NOTICIAS FARMACEUTICAS INTERNACIONALES DEL 18 DE AGOSTO AL 22 DE AGOSTO DEL 2014.

INDEX:

Jim Hindman to replace outgoing Allergan CFO Jeff Edwards.

Allergan said to have contacted Salix about possible takeover.
Data back Amgen drug for overactive thyroid in dialysis patients.
AZ gets all-clear in the USA over Brilinta data.
AZ inks diabetic nephropathy pact with Mitsubishi Tanabe.
B-MS hooks up with Celgene to test cancer combo.
FDA approves Biogen MS drug Plegridy.
GlaxoSmithKline’s Arnuity Ellipta cleared by FDA for asthma.

Glenmark starts IND-enabling studies of new bispecific antibody.

Lilly says Ixekizumab superior to Enbrel, placebo in Phase III psoriasis studies.

Novartis takes option to buy Israel’s Gamida Cell.
Novo accepts Denmark fine in Tresiba disclosure case.
Pfizer completes filing of palbociclib for breast cancer.
Roche’s Avastin plus chemotherapy gets FDA approval for cervical cancer treatment.
Chugai denies talks with Roche about buy-out.
Sanofi’s oral Gaucher disease therapy Cerdelga garners FDA approval.
Valeant extends tender offer to acquire Allergan to December 31.

Jim Hindman to replace outgoing Allergan CFO Jeff Edwards.
Allergan disclosed Monday that chief financial officer Jeff Edwards is stepping down “due to family commitments,” adding that company veteran Jim Hindman was selected as his replacement and will assume the role of executive vice president for finance and business development, effective immediately. Hindman, who joined Allergan in 1984, has served as senior vice president for treasury, risk and investor relations at the drugmaker since 2002. Meanwhile, Edwards will remain employed by Allergan in a non-executive officer capacity “to facilitate a smooth transition.”
http://www.firstwordpharma.com/node/1230588?tsid=28&region_id=6#axzz3Al85LxLE, Published 18 August 2014

Allergan said to have contacted Salix about possible takeover.
According to people close to the matter, Allergan has approached Salix Pharmaceuticals and at least one other drugmaker regarding a possible acquisition as it looks to rebuff a hostile takeover attempt from Valeant Pharmaceuticals, The Wall Street Journal reported Tuesday. One person suggested that Allergan could reach a deal with one of the companies as early as next month. Salix is currently completing its acquisition of Italian drugmaker Cosmo Pharmaceuticals, which it is purchasing in an all-stock transaction as part of a tax-inversion deal. It is unclear whether Allergan would also purchase Cosmo if it acquires Salix, or whether the deal would itself be a tax inversion. Allergan was previously rumoured to have interest in an acquisition of Shire, which subsequently agreed to a merger with AbbVie. Allergan’s reported interest in Salix comes as Valeant and Allerganm shareholder Pershing Square Capital Management pursue an acquisition of the US company. Earlier this week, Valeant revealed that it is extending its tender offer to acquire all outstanding shares of Allergan until December 31, while a source indicated that Pershing Square is nearly at the 25-percent threshold of shareholders needed to call a special shareholder meeting to potentially oust six Allergan directors. Meanwhile, Allergan, which unanimously rejected Valeant’s exchange offer in June, filed a US lawsuit earlier this month accusing the Canadian drugmaker and Pershing Square of “violating federal laws” prohibiting insider trading.
http://www.firstwordpharma.com/node/1230902?tsid=28&region_id=2#axzz3AwH8fCb6, Published 20 August 2014

Data back Amgen drug for overactive thyroid in dialysis patients.
A second Phase III trial of Amgen’s AMG 416 has also hit targets showing that the drug is effective in reducing thyroid levels in kidney disease patients receiving dialysis who have developed secondary hyperparathyroidism. Secondary HPT is a common, serious and often progressive condition among patients with chronic kidney disease. It develops in response to declining kidney function, when the parathyroid (PTH) glands increase the production of thyroid to maintain normal levels of calcium and phosphorus. However, eventually this excess production is not enough to maintain normal levels, and at the point of CKD dialysis, this manifests as abnormal amounts of PTH, calcium and phosphorus that, in turn, can lead to significant clinical consequences, such as weakness and thinning of the bones. In the Phase III trial, 74% of patients given AMG 416 experienced a greater than 30% reduction from baseline in PTH compared with 8.3% in the placebo arm. Secondary goals of change in serum phosphorus concentration (mean changes of -7.71% and -1.31% in the AMG 416 and placebo arms, respectively) and corrected calcium concentration (-7.29% and 1.18%), were also met.

http://www.pharmatimes.com/Article/14-08-19/Data_back_Amgen_drug_for_overactive_thyroid_in_dialysis_patients.aspx, Published 19 August 2014

AZ gets all-clear in the USA over Brilinta data.
AstraZeneca has been boosted by the news that the US government has closed its investigation into a Phase III trial that formed the basis for the approval of its closely-watched heart drug Brilinta and will take no further action. Last October, AstraZeneca received a civil investigative demand from the Department of Justice seeking documents and information related to the 18,624-patient PLATO trial. Data from the latter led to a US Food and Drug Administration green light in 2011 for Brilinta (ticagrelor) for acute coronary syndrome and the drug has now been approved in over 100 countries. However, certain aspects of the study, which established the superiority of Brilinta over Sanofi’s Plavix (clopidogrel) had been criticised in some quarters. Concerns included difference in treatment effect observed in the US and non-US patient subsets (Poland and Hungary accounted for 21% of patients evaluated) and a paper published in the International Journal of Cardiology last year, which alleged “multiple serious deficiencies” in the PLATO data. AstraZeneca chief executive Pascal Soriot said the firm welcomes the DoJ’s decision not to pursue further action, noting that “we have always had absolute confidence in the integrity of the PLATO trial and we are proud of the important benefit Brilinta offers”. He added that “as one of AstraZeneca’s growth platforms, we are committed to delivering the full potential of this important medicine.” Brilinta, sold as Brilique in the UK, has struggled to make much impact since launch, although second-quarter sales leapt 78% to $114 million and the DoJ decision should help. In the wake of Pfizer’s hostile takeover bid earlier this year, AstraZeneca set a sales target for Brilinta of $3.5 billion by 2023. AstraZeneca recently announced the start of the SOCRATES trial, studying Brilinta for patients with acute ischemic stroke or transient ischemic attack, and the THEMIS study in patients with type 2 diabetes and coronary atherosclerosis. They form part of PARTHENON, the company’s largest ever clinical trial programme, involving more than 80,000 patients.

http://www.pharmatimes.com/Article/14-08-19/AZ_gets_all-clear_in_the_USA_over_Brilinta_data.aspx, Published 19 August 2014

AZ inks diabetic nephropathy pact with Mitsubishi Tanabe.
AstraZeneca and Mitsubishi Tanabe Pharma Corp are linking up to find treatments for diabetic nephropathy. The companies have signed an early-stage three-year research collaboration to develop small molecule candidates from their respective portfolios that have been identified as treatments for the disease which involves kidney failure due to diabetes. Diabetic nephropathy occurs in as many as 50% of patients who have diabetes for 20 years or more. The research will be performed at MTPC’s facilities in Japan and at AstraZeneca’s cardiovascular and metabolic disease innovative medicines unit in Molndal, Sweden. There is no financial commitment for the research involved and each firm will contribute equal resources at their own cost. Marcus Schindler, head of the CVMD iMed, said diabetes is a key growth platform for AstraZeneca, noting that “with current approaches to diabetic nephropathy resulting in patients needing expensive and limited treatment options, such as dialysis or kidney transplantation, there’s a significant unmet clinical need”. He added that the MTPC pact “will allow us to focus on early-stage programmes and generate decision-making data faster than working alone.”
http://www.pharmatimes.com/Article/14-08-20/AZ_inks_diabetic_nephropathy_pact_with_Mitsubishi_Tanabe.aspx, Published 20 August 2014

B-MS hooks up with Celgene to test cancer combo.
Bristol-Myers Squibb and Celgene have formed a clinical trial alliance to work together on a potential new cancer combination therapy. The firms will conduct a Phase I study to evaluate the safety, tolerability and early efficacy of a regimen of B-MS’ investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) and Celgene’s chemotherapy Abraxane (paclitaxel protein-bound particles for injectable suspension). The study – which is expected to begin in the fourth quarter of 2014 and will be carried out by Celgene – will look at multiple tumour types, including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC). The companies are hoping that combining the immunotherapy Opdivo, which targets distinct regulatory components of the immune system, with the chemotherapy Abraxane, which works by interfering with the ability of cancer cells to divide, will lead to a greater anti-tumour response than either agent alone. Further details on the deal, the latest in a growing line of clinical trial hook ups within the cancer immunotherapy field, were not disclosed.
http://www.pharmatimes.com/Article/14-08-20/B-MS_hooks_up_with_Celgene_to_test_cancer_combo.aspx, Published 21 August 2014

FDA approves Biogen MS drug Plegridy.
Regulators in the USA have given the green light to another Biogen Idec multiple sclerosis drug, this time Plegridy. The US Food and Drug Administration has approved Plegridy (peginterferon beta-1a) for relapsing forms of MS. dosed once every two weeks. The treatment, which has got the thumbs-up based on data from a 1,500-patient study, can be administered subcutaneously with a ready-to-use autoinjector or a prefilled syringe. Biogen quoted Peter Wade of the Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research in Hartford, Connecticut, as saying that Plegridy is “a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every two-week dosing schedule administered by an innovative delivery system”. He added that “as a treating neurologist, I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness”. While the MS market now has oral treatments, including Biogen’s own Tecfidera (dimethyl fumarate), Plegridy is still expected to be a successful product thanks to offering less frequent injections and it should also be less painful than the company’s older blockbuster Avonex (interferon beta-1a) which is given intramuscularly. In March, the FDA extended the initial Prescription Drug User Fee Act (PDUFA) date for Plegridy by three months, saying it needed more time to review the file. The European Commission approved the therapy last month.
http://www.pharmatimes.com/Article/14-08-16/FDA_approves_Biogen_MS_drug_Plegridy.aspx, Published 18 August 2014

GlaxoSmithKline’s Arnuity Ellipta cleared by FDA for asthma.
GlaxoSmithKline announced Wednesday that the FDA approved Arnuity Ellipta (fluticasone) as a once-daily maintenance treatment for asthma in patients aged 12 and older. The company said approval of the corticosteroid, which is administered via the Ellipta dry-powder inhaler, was supported by safety and efficacy data in more than 3600 patients with asthma. Darrell Baker, head of GlaxoSmithKline’s global respiratory franchise, described the regulatory clearance as “an important development for [the company] and our expanding respiratory portfolio.” The drugmaker specified that Arnuity Ellipta is not cleared for the treatment of acute bronchospasm
http://www.firstwordpharma.com/node/1231256?tsid=28&region_id=2#axzz3AwH8fCb6, Published 21 August 2014

Glenmark starts IND-enabling studies of new bispecific antibody.
Glenmark Pharmaceuticals has started the investigational new drug (IND)-enabling studies of a new bispecific antibody. Discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland, GBR 1302 is a HER2xCD3 bispecific antibody based on the company’s BEAT antibody technology platform. Also known as HER2/neu, or receptor tyrosine-protein kinase erbB-2, HER2 is the target of the antibody cancer drugs trastuzumab, pertuzumab and trastuzumab emtansine and is involved in breast cancer and ovarian cancer. GBR 1302 differs from existing HER2 targeting antibodies by redirecting cytotoxic T cells through its CD3 binding arm onto HER2 expressing cancer cells and inducing the killing of the cancer cells. The antibody kills cancer cells more rapidly and completely, and the killing is not subjected to the same resistance escape mechanisms as competing therapies. Glenmark Pharmaceuticals Biologics chief scientific officer and president Dr. Michael Buschle said: “GBR 1302 is significant for Glenmark on multiple levels: It is our first bispecific antibody, it is our first antibody based on our proprietary BEAT antibody engineering platform and it represents the entry of Glenmark into the Oncology innovator space, which has a huge commercial potential.” The company expects to secure approval for the initiation of GBR 1302 clinical studies during the current financial year.
http://drugdiscovery.pharmaceutical-business-review.com/news/glenmark-starts-ind-enabling-studies-of-new-bispecific-antibody-210814-4349389, Published 22 August 2014

Lilly says Ixekizumab superior to Enbrel, placebo in Phase III psoriasis studies.
Eli Lilly announced Thursday that the experimental drug ixekizumab was “statistically superior” to Amgen’s Enbrel (Etanercept) and placebo on all skin clearance measures in three Phase III studies in patients with moderate-to-severe plaque psoriasis. “These data are important…as up to 41 percent of those treated with ixekizumab were able to achieve clear skin at week 12, with just one injection per dose,” remarked David Ricks, president of Lilly Bio-Medicines. The UNCOVER studies included a total of 3866 patients who had a confirmed diagnosis of chronic plaque psoriasis for at least six months prior to randomisation. In all three trials, subjects were assigned to receive either placebo or ixekizumab. In UNCOVER-1, responders to treatment were assigned to continue treatment with placebo or ixekizumab for up to 60 weeks, while in UNCOVER-2 and 3, patients could be assigned to receive Enbrel twice weekly for 12 weeks. Eli Lilly noted that all primary and key secondary goals were met in the studies. Specifically, top-line results showed that for patients treated with ixekizumab either every four weeks or every two weeks, between 78 percent and 90 percent of patients achieved at least a 75 percent reduction in PASI score at 12 weeks. In addition, 31 percent to 41 percent of these patients achieved PASI 100 at week 12, versus between 5 percent and 7 percent of those given Enbrel in the UNCOVER-2 and 3 studies.
http://www.firstwordpharma.com/node/1231285?tsid=28&region_id=6#axzz3AwH8fCb6, Published 21 August 2014

Novartis takes option to buy Israel’s Gamida Cell.
Novartis has bought a 15% stake in Gamida Cell, with an option to acquire the Israel-headquartered stem cell specialist. The Swiss major is investing $35 million initially and if it exercises the option, which expires in the first half of 2016 would pay the other shareholders in Gamida some $165 million. Novartis could also pay up to $435 million, depending on certain development, regulatory and sales milestones. These would relate to NiCord, a stem cell treatment which is in Phase I/II for haematological malignancies such as leukaemia and lymphoma. In March, main Gambia stakehiolder Elbit Medical said it had received a buyout bid from an unnamed global pharmaceutical firm, widely reported to be Novartis and thought to be worth $600 million, including an upfront fee of $170 million. However in May, Elbit said talks had been terminated.
http://www.pharmatimes.com/Article/14-08-19/Novartis_takes_option_to_buy_Israel_s_Gamida_Cell.aspx, Published 20 August 2014

Novo accepts Denmark fine in Tresiba disclosure case.
Novo Nordisk has accepted a fine from Danish regulators over allegations of violating disclosure obligations concerning US rejection of its diabetes drugs Tresiba and Ryzodeq.
A 500,000 kroner fine (just under £53,600) has been imposed by the public prosecutor in a suit filed by the Danish Financial Supervisory Authority. The case stems from Novo’s receipt of a complete response letter from the US Food and Drug Administration for Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart) on the evening of Friday February 8 in 2013. Novo published the FDA’s decision on Sunday 10 February 2013 “following an intensive investigation and evaluation of the implications and impact of the agency’s decision”. However, in the opinion of the FSA and the public prosecutor, the announcement should have been issued on the Friday evening because, even though the market in Denmark was closed, Novo shares could still be traded in the USA.
In February last year, the Nasdaq in Copenhagen launched a similar investigation but declared in May 2013 that it found no basis for concluding Novo had violated the rules, and that it considered the matter closed. Novo insists that the announcement was issued “in a timely manner [and] was entitled to delay public disclosure until the implications of the decision had been adequately analysed, which they had been on the Sunday”. However, “for resource reasons”, the company’s management has chosen to accept the fine “to avoid a lengthy lawsuit”. Novo expects to resubmit Tresiba for US approval in mid-2015 as a cardiovascular outcomes trial requested by the FDA is progressing quicker than scheduled. It is already approved in Europe
http://www.pharmatimes.com/Article/14-08-18/Novo_accepts_Denmark_fine_in_Tresiba_disclosure_case.aspx, Published 19 August 2014

Pfizer completes filing of palbociclib for breast cancer.
Pfizer says it has completed the submission of a New Drug Application to US regulators for its breast cancer drug palbociclib. The drugs giant is hoping to get approval from the US Food and Drug Administration for palbociclib, in combination with the aromatase inhibitor letrozole, for the treatment of postmenopausal women with oestrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a Phase II trial comparing palbociclib plus letrozole versus the latter alone in this population of patients. The Pfizer drug received breakthrough therapy designation from the FDA in April 2013 based on interim data from the mid-stage study which showed a statistically significant improvement in median progression free survival compared to letrozole alone (26.1 months versus 7.5 months). The FDA has a 60-day filing review period to determine whether the NDA is acceptable for filing. Palbociclib selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumour cell proliferation.
http://www.pharmatimes.com/Article/14-08-19/Pfizer_completes_filing_of_palbociclib_for_breast_cancer.aspx, Published 19 August 2014

Roche’s Avastin plus chemotherapy gets FDA approval for cervical cancer treatment.
Roche has received approval from the US Food and Drug Administration (FDA) for Avastin (bevacizumab) in combination with paclitaxel and cisplatin or paclitaxel and topotecan to treat women with persistent, recurrent or metastatic carcinoma of the cervix. With this approval in advanced cervical cancer, Avastin is approved in the US for the treatment of five distinct tumor types. The FDA approval is based on the GOG-0240 study, which evaluated the efficacy and safety profile of Avastin plus chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in these women. GOG-0240 is an independent, National Cancer Institute (NCI)-sponsored study of the Gynecologic Oncology Group (GOG). Roche Global Product Development chief medical officer and head Dr Sandra Horning said with the approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone. “Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread,” Horning said. Data from 452 women showed that the GOG-0240 study met its primary endpoint of improving overall survival (OS) with a statistically significant 26% reduction in the risk of death for women who received Avastin plus chemotherapy compared to those who received chemotherapy alone. According to the study, women who received Avastin plus chemotherapy had a significantly higher rate of tumor shrinkage (objective response rate, ORR) compared to chemotherapy alone.
http://drugdiscovery.pharmaceutical-business-review.com/news/roches-avastin-plus-chemotherapy-gets-fda-approval-for-cervical-cancer-treatment-180814-4345268, Published 18 August 2014

Chugai denies talks with Roche about buy-out.
Chugai Pharmaceutical Co has denied a report published by Bloomberg that Roche was going to pay $10 billion to take full control of the Japanese company. The Tokyo-based firm said that the report “is not based on any announcement made by Chugai or Roche”. It is “in no way in the process of reviewing any plan to become a wholly-owned subsidiary of Roche, nor discussing with [the Swiss major] about such a transaction”. Bloomberg had cited unnamed sources supposedly familiar with the matter that Roche was in talks to buy the 38% of Chugai it does not own. It took a controlling 50.1% stake back in October 2002 for about $1.4 billion and has increased its stake since then. Roche has shied away from major acquisitions of late and chief executive Severin Schwan said last month he is more interested in bolt-ons. Recently it has bought US firm’s Seragon Pharmaceuticals (up to $1.7 billion) and Genia Technologies (up to $350 million), plus Denmark’s Santaris (up to $450 million). Chugai is focused on oncology, as well as renal and bone diseases. Sales reached $4.4 billion last year.
http://www.pharmatimes.com/Article/14-08-17/Chugai_denies_talks_with_Roche_about_buy-out.aspx, Published 18 August 2014

Sanofi’s oral Gaucher disease therapy Cerdelga garners FDA approval.
Sanofi’s Genzyme unit announced that Cerdelga (eliglustat) gained approval from the FDA, making the drug the “only first-line oral therapy” for certain adults with Gaucher disease type 1. The company noted that the glucosylceramide analogue is expected to be available to patients within a month. Commenting on the news, Amy G. Egan, deputy director of the Office of Drug Evaluation III in the FDA’s Center for Drug Evaluation and Research, said the “approval offers another important treatment option for patients with Type 1 Gaucher disease.” The agency, which granted Genzyme’s filing for Cerdelga priority review last year, noted that the decision was based on safety and effectiveness data from two Phase III trials that included 199 patients with Type 1 Gaucher disease. In one study that included 40 patients who had not previously received enzyme replacement therapy, results showed that compared to placebo, treatment with Cerdelga resulted in a greater reduction in spleen volume from baseline to the end of the study. In addition, Cerdelga also resulted in greater improvements in liver volume, blood platelet count and haemoglobin levels versus placebo. The second trial included 159 patients previously treated and stabilised on enzyme replacement therapy. Results of the study demonstrated that treatment with Cerdelga resulted in similar stabilisation of haemoglobin levels, platelet count and spleen and liver volume as Genzyme’s Cerezyme (imiglucerase). The company said that patients who metabolise Cerdelga more quickly or at an undetermined rate, as detected by an established genetic laboratory test, will not be eligible for treatment with the drug. Marketing applications for Cerdelga are also currently under review by the European Medicines Agency and other regulatory bodies.
http://www.firstwordpharma.com/node/1231027?tsid=28&region_id=2#axzz3AwH8fCb6, Published 20 August 2014

Valeant extends tender offer to acquire Allergan to December 31.
Valeant Pharmaceuticals disclosed Friday that it was extending itstender offer to acquire all outstanding shares of Allergan until December 31. The exchange offer was previously scheduled to expire on August 15. Valeant initiated the hostile move of taking its most recentunsolicited bid directly to Allergan’s shareholders in June. Valeant said that as of August 15, approximately 12.5 million Allergan shares had been properly tendered and not validly withdrawn. Under the terms of the offer, Allergan stockholders would be able to exchange each of their shares for $72 in cash and 0.83 Valeant common shares, or an amount of cash, or a number of Valeant common shares. Separately, Allergan shareholder Pershing Square Capital Management, which is assisting Valeant in its efforts to purchase the US drugmaker, has called for a special shareholders meeting in an effort to replace several members of Allergan’s board. Pershing Square requires the support of at least 25 percent of Allergan shareholders in order to hold the meeting, and the solicitation is expected to conclude in the coming days, according to people close to the matter. Meanwhile, Allergan’s board, which has frequently criticised Valeant’s business model, unanimously rejected the exchange offer as “grossly inadequate.” The US drugmaker later announced its intentions to reduce its workforce by 1500 positions as part of a restructuring initiative (For related analysis, see ViewPoints: Allergan delivers cost cuts, but acquisition of its own still needed to derail Valeant’s approach). Allergan also recently filed a lawsuit accusing the Canadian drugmaker and Pershing Square of violating US federal laws prohibiting insider trading. Sources have since revealed that the US Securities and Exchange Commission opened a probe into Valeant and Pershing Square’s hostile bid.
http://www.firstwordpharma.com/node/1230532?tsid=28&region_id=2#axzz3Al85LxLE, Published 18 August 2014

NOTICIAS FARMACEUTICAS INTERNACIONALES DEL 11 DE AGOSTO AL 15 DE AGOSTO DEL 2014.

INDEX:

Amgen, Onyx Pharmaceuticals’ Kyprolis fails to meet primary endpoint in Phase III trial in multiple myeloma.
Astellas links up with CR UK for pancreatic cancer.
AstraZeneca’s gout drug lesinurad succeeds in Phase III.
AstraZeneca advances experimental asthma drug tralokinumab into Phase III trials.
Another green light in Europe for Bayer’s Eylea.
Boehringer suffers tough first half but pipeline positive.
Boehringer acquires licensing rights for Artilysin technology from Lysando.
FDA approves J&J diabetes drug Invokamet.
British drugmaker GlaxoSmithKline (GSK) spokesperson has said that its experimental Ebola vaccine may enter into clinical trial “later this year.”
GSK investigates new bribery claims in Syria.
Solid quarter for Merck KGaA but Rebif under pressure.
Merck & Co.’s insomnia drug Belsomra, gets U.S. approval.
Pfizer explores IBD in pact with 23andMe.
Sanofi to pay up to $900m to Mannkind for share in insulin Afrezza.
Sanofi licenses preclinical drugs to China’s Zai Lab.
Sanofi’s US pharma head joins Synta as CEO.
Sun Pharma likely to enter Japanese market in four years
WHO panel says ethical to use unproven drugs, vaccines to fight Ebola outbreak.

Amgen, Onyx Pharmaceuticals’ Kyprolis fails to meet primary endpoint in Phase III trial in multiple myeloma.
Amgen and subsidiary Onyx Pharmaceuticals on Wednesday announced that Kyprolis (carfilzomib) did not meet its primary endpoint of improving overall survival (OS) compared to an active comparator in a Phase III trial involving patients with relapsed and advanced refractory multiple myeloma. “While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase III clinical trial will be sufficient to support regulatory submissions around the world,” remarked Onyx Pharmaceuticals president Pablo J. Cagnoni. The FOCUS trial randomised 315 patients to receive Kyprolis or an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide. Amgen noted that patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry. Secondary endpoints of the study included progression-free survival, overall response rate, clinical benefit rate, duration of response and safety. Amgen noted that treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms, although there was an increase in the incidence of renal adverse events of all grades observed in the Kyprolis arm. Further, the rate of cardiac events observed in the Kyprolis arm was consistent with the current US Kyprolis label. The drugmaker noted that detailed results from the trial will be submitted for presentation at an upcoming scientific meeting. Kyprolis was acquired by Amgen last year as part of its $9.7 billion takeover of Onyx Pharmaceuticals. The therapy previously garnered FDA approval for treating advanced multiple myeloma based on data showing that patients responded to the drug.
http://www.firstwordpharma.com/node/1230145?tsid=28&region_id=2#axzz3ANQplMs6, Published 14 August 2014

Astellas links up with CR UK for pancreatic cancer.
Cancer Research UK has linked up with Astellas Pharma to find new drug targets for pancreatic cancer. The two-year collaboration is based on research which suggests that certain pancreatic cancers are dependent on autophagy, the process of consuming a person’s own cellular parts for energy, in order to grow. The first stage of the pact aims to identify and then validate the best possible drug targets to block the autophagy pathway in pancreatic cancer cells. Astellas has an exclusive licence to progress the most promising candidates and will pay undisclosed milestone and royalty payments to Cancer Research UK’s commercial arm, Cancer Research Technology. Kenji Yasukawa, chief strategy officer at Astellas, said that since May 2013, the company has been looking to establish links with overseas researchers “who have ideas that possess a high level of novelty and creativity”.
http://www.pharmatimes.com/Article/14-08-11/Astellas_links_up_with_CR_UK_for_pancreatic_cancer.aspx, Published 11 August 2014

AstraZeneca’s gout drug lesinurad succeeds in Phase III.
AstraZeneca has posted positive top-line late-stage results on its investigational gout drug lesinurad. Three Phase III studies looked at lesinurad, a selective uric acid (sUA) re-absorption inhibitor, in combination with xanthine oxidase inhibitors – two trials with allopurinol and one with Takeda’s Uloric (febuxostat). The drug reached its primary endpoints, by reducing sUA levels and AstraZeneca is looking to file its 200mg combo dose: the incidence of renal-related adverse events and kidney stones was higher with lesinurad 400mg plus an XO inhibitor. Chief medical officer Briggs Morrison said there is a significant unmet need, with 40%-70% of gout patients not reaching target levels of sUA with the current standard of care. He added that these data indicate that combination therapy with lesinurad may be a potential treatment option. AstraZeneca got hold of lesinurad through its $1.26 billion acquisition of Ardea Biosciences in June 2012.
http://www.pharmatimes.com/Article/14-08-13/AstraZeneca_s_gout_drug_lesinurad_succeeds_in_Phase_III.aspx, Published 13 August 2014
AstraZeneca advances experimental asthma drug tralokinumab into Phase III trials.
AstraZeneca announced Thursday that it has begun late-stage trials evaluating the safety and effectiveness of tralokinumab at lowering the rate of asthma exacerbations in adults and adolescents with severe, inadequately controlled asthma despite receiving inhaled corticosteroids plus long-acting beta 2-agonist. The company said the Phase III programme will also assess the effect of tralokinumab on lung function, patient-reported asthma symptoms and quality of life, as well as evaluate whether potential clinical biomarkers could identify patients who are more likely to respond to the experimental IgG4 monoclonal antibody, which targets the asthma-associated cytokine interleukin-13
http://www.firstwordpharma.com/node/1230239?tsid=28&region_id=6#axzz3ANQplMs6, Published 14 August 2014

Another green light in Europe for Bayer’s Eylea.
The European Commission have granted a fresh approval to Bayer’s eye drug Eylea, this time for diabetic macular oedema. Eylea (aflibercept), the European rights for which are licensed from Regeneron, can now be used for the treatment of visual impairment due to DMO, which is estimated to affect 3-4% of people with diabetes. This makes it the most frequent cause of blindness in young and mid-aged adults in most developed countries and Bayer says it plans an immediate roll-out with Germany being one of the first launch countries in Europe. The company quoted Jean-Francois Korobelnik of the Centre Hospitalier Universitaire de Bordeaux as saying that the results of two Phase III studies “were very encouraging with the majority of patients with visual impairment due to DMO experiencing a significant two-line improvement in visual acuity” with the injection. He added that early diagnosis “is critical, and if not treated rigorously, there is a high risk of DMO leading to blindness”. Eylea is already approved in Europe for wet age-related macular degeneration and macular oedema following central retinal vein occlusion. It was given the green light for DMO in the USA at the end of last month, going up against Novartis/Roche’s Lucentis (ranibizumab) and the latter’s Avastin (bevacizumab), which is used off-label to treat the condition.
http://www.pharmatimes.com/Article/14-08-11/Another_green_light_in_Europe_for_Bayer_s_Eylea.aspx, Published 15 August 2014

Boehringer suffers tough first half but pipeline positive.
Boehringer Ingelheim says it overcame “major challenges” in the first half of 2014 which saw sales fall 7.9% to around 6.5 billion euros. The decline was due principally to the effects of currency and price reductions in the USA. Prescription medicines sales were down 5.4% (currency adjusted) to 4.79 billion euros, driven again by its blockbuster chronic obstructive pulmonary disease therapy Spiriva (tiotropium), bringing in 1.62 billion euros. Trajenta (linagliptin) for type 2 diabetes, which BI is not launching in Germany (after regulators there decided the therapy did not warrant premium pricing) climbed over 63% to over 300 million euros (currency adjusted). The greatest growth was achieved by its new lung cancer, Giotrif (afatinib). However, privately-owned BI did not give any details about sales of its anticoagulant Pradaxa (dabigatran), the subject of a $650 million payment to settle 4,000 lawsuits in the USA in May. Chairman Andreas Barner said that “we can now concentrate all our efforts on the development and launch of new medicines and on the expansion of our biopharmaceutical business”.
http://www.pharmatimes.com/Article/14-08-11/Boehringer_suffers_tough_first_half_but_pipeline_positive.aspx, Published 12 August 2014

Boehringer acquires licensing rights for Artilysin technology from Lysando.
Artilysin, a new and innovative technological approach in the fight against pathogenic and multi-resistant bacteria, developed by the research & development company Lysando, has arrived in the pharmaceutical industry. Boehringer Ingelheim Vetmedica has secured the licensing rights for the technology platform Artilysin®. The company is hopeful to receive significant momentum and solutions from this new substance class for the problem of multi-resistant bacteria, which also is an increasing threat to the animal world. Artilysin®s are proteins that, through a physical mechanism, selectively eliminate pathogenic, multi-resistant and persisting bacteria. By way of license, Boehringer Ingelheim Vetmedica is taking advantage of the possibilities presented by this technology. The scope of applications for Artilysins spans from human and animal medicine to the food industry and the area of hygiene. They work quickly and with their “friend or foe” identification very specifically and are completely biodegradable. Additionally, no resistances occurred during the expansive studies. Multi-resistant bacteria pose a significant threat to health due to the increasing ineffectiveness of antibiotics. The EU Commission estimates the annual number of deaths caused by multi-resistant bacteria at 25,000. Massive economic effects are linked to this fact. The Boehringer Ingelheim Group is among the 20 leading pharmaceutical companies worldwide. Their focus areas include research & development, production and marketing of new medicines with significant therapeutic benefits for human and animal health. In 2013, Boehringer Ingelheim reported revenues of appr. 14.1 bn Euros. Lysando itself is not a manufacturer of pharmaceutical products nor will it become one in the future; it only provides its new technology platform through licensing. „The acquisition of licensing rights for the Artilysin® technology by Boehringer Ingelheim Vetmedica is a decisive step in the acceptance of this new class of substances”, explains Markus Matuschka v. Greiffenclau, CEO of Lysando AG.
http://contractresearch.pharmaceutical-business-review.com/news/boehringer-acquires-licensing-rights-for-artilysin-technology-from-lysando-130814-4342712, Published 13 August 2014

FDA approves J&J diabetes drug Invokamet.
Regulators in the USA have given the green light to Johnson & Johnson’s new diabetes combo Invokamet. The US Food and Drug Administration has approved Invokamet, a fixed-dose therapy combining Invokana (canagliflozin) and metformin. The former, a member of the new class of drugs known as sodium glucose co-transporter 2 (SGLT2) inhibitors, was approved in the USA as a single agent in March last year. The thumbs-up is based on Phase III studies which showed that the combo lowered blood sugar and reduced secondary endpoints of body weight and systolic blood pressure to a greater degree than metformin alone. Invokamet is the first fixed–dose combination of an SGLT2 inhibitor with metformin to be approved in the USA and is available at two doses (50mg/500mg or 150mg/1000 mg, to be taken twice daily. Canagliflozin works with the kidney to promote the loss of glucose in the urine, whereas metformin decreases the production of glucose in the liver and improves the body’s response to insulin. Jimmy Ren, head of metabolics medical affairs at J&J’s Janssen Pharmaceuticals unit, said that the two doses allow physicians “to tailor therapy for individual patient needs and offer an alternative for patients who may be able to reduce the number of tablets they take each day”. As for Invokana, it is the number–one branded non–insulin type 2 diabetes medication newly prescribed by US endocrinologists and since its launch, more than one million prescriptions have been written. The combo was approved in Europe in April, where it is marketed as Vokanamet.
http://www.pharmatimes.com/Article/14-08-10/FDA_approves_J_J_diabetes_drug_Invokamet.aspx, Published 11 August 2014

British drugmaker GlaxoSmithKline (GSK) spokesperson has said that its experimental Ebola vaccine may enter into clinical trial “later this year.”
The vaccine is being developed by GSK in collaboration with scientists at the US National Institute of Allergy and Infectious Diseases (NIAID). In primates, the vaccine has already shown promising results and is likely to get underway into Phase I testing in humans following approval from the US Food and Drug Administration (FDA). NIAID said in a statement that testing would start “as early as fall 2014” or in September. Noting that the vaccine may not be put in place for widespread deployment before 2015, a GSK official was quoted by The Guardian as saying: “It is right at the beginning of the development journey and still has a very long way to go.” The new experimental vaccine, which was acquired by GSK after the purchase of the Swiss-based biotech company Okairos, is based on a chimpanzee adenovirus. The World Health Organisation (WHO) has recently declared an international health emergency for Ebola, which has been reported to have claimed the lives of nearly 1,000 people in the Liberia, Sierra Leone and Guinea, Africa. The US has already partnered with European countries and WHO to combat the widespread of Ebola. Johnson & Johnson’s Crucell unit is also working on an early-stage Ebola vaccine, which may enter Phase I clinical testing in late 2015 or early 2016. Additionally, NewLink Genetics had received a letter contract from the US Defense Threat Reduction Agency (DTRA) for testing and evaluating an Ebola virus vaccine.
http://drugdiscovery.pharmaceutical-business-review.com/news/glaxosmithklines-ebola-vaccine-may-enter-clinical-trials-soon-110814-4339539, Published 11 August 2014

GSK investigates new bribery claims in Syria.
GlaxoSmithKline is investigating fresh bribery allegations reported by Reuters concerning its operations in Syria.The news agency published details of an anonymous internal email containing claims that Syrian doctors were bribed with cash, trips and free samples to help boost cancer and blood-clotting sales. Just last month, similar allegations emerged about its consumer business in the country. GSK said that “we have zero tolerance for any kind of unethical behaviour and we welcome people speaking up if they have concerns about alleged misconduct”. It added that all the claims in the email “will be thoroughly investigated using internal and external resources as part of our ongoing investigation into operations in Syria”. The UK-based giant stated that “we have suspended our relationship with our distributors in the country pending the outcome of our investigation”.
http://www.pharmatimes.com/Article/14-08-12/GSK_investigates_new_bribery_claims_in_Syria.aspx, Published 12 August 2014

Solid quarter for Merck KGaA but Rebif under pressure.
Merck KGaA has posted a reasonable set of financials for the second quarter, although competition from oral therapies is beginning to hurt sales of the German firm’s multiple sclerosis drug Rebif. Net income was down 4.1% to 303.3 million euros, while sales were up 1.9% to 2.80 billion euros, despite being hit by negative foreign exchange effects of around 4.5%. The company noted that “strong currency headwinds” overshadowed solid organic sales growth at its Merck Serono unit where turnover dipped 1.4% to 1.45 billion euros. Rebif (interferon beta-1a) was down 7.0% to 464 million euros “against the backdrop of an increasingly difficult competitive situation” and price rises last year did not compensate for lower sales hit by pills such as Novartis’ Gilenya (fingolimod), Biogen Idec’s Tecfidera (dimethyl fumarate) and Sanofi’s Aubagio (teriflunomide). In June, Merck pulled the plug on investigational MS drug after “considering the significant change in market circumstances”. The colorectal/head and neck cancer drug Erbitux (cetuximab) contributed 229 million euros, up 6.5% despite negative currency effects of -4.9%. Sales of the fertility drug Gonal-f (follitropin)rose 3.9% to 161 million euros, helped by a strong showing in China. Merck chairman Karl-Ludwig Kley described the quarter as sold, noting that all of the company’s businesses performed well in the emerging markets, saying that its focus “on this attractive region is visibly paying off”. On a conference call, he repeated his view that Merck could join the M&A merry-go-round, thanks to its strong balance sheet and cash flow “but we don’t have to pursue acquisitions”.
http://www.pharmatimes.com/Article/14-08-13/Solid_quarter_for_Merck_KGaA_but_Rebif_under_pressure.aspx, Published 14 August 2014

Merck & Co.’s insomnia drug Belsomra, gets U.S. approval.
The FDA said Wednesday that it approved Merck & Co.’s Belsomra (suvorexant) to treat people with insomnia, making it the first orexin receptor antagonist cleared for use in the country. The agency, which has previously rejected the drug on grounds that evidence did not support approval at higher doses, cleared Belsomra at dosage strengths ranging from 5 mg to 20 mg, lower than what Merck had originally sought to market. After issuing a complete response letter for the therapy, the FDA directed the drugmaker to conduct a study assessing next-day driving performance in individuals who used the therapy, with the data identifying driving impairment in both males and females who received the 20-mg dose. Consequently, the regulator cautioned that patients using the highest dose should be advised against next-day driving and other activities requiring mental alertness, while those using lower doses should also be warned of the potential for next-day driving impairment due to individual variation in sensitivity to the drug. “Using the lowest effective dose can reduce the risk of side effects, such as next-morning drowsiness,” remarked Ellis Unger, director of the Office of Drug Evaluation I in the FDA’s Center for Drug Evaluation and Research. The efficacy of Belsomra was supported by three trials involving more than 500 patients. In the studies, patients who received the drug fell asleep faster and spent less time awake throughout the night than those who received placebo. The FDA noted that because the therapy was not compared to other approved drugs, its safety and efficacy relative to other medicines are unknown. Analysts project that Belsomra will generate revenue of $305 million by 2017, down from an earlier estimate of $516 million before the FDA declined to approve the therapy at higher doses. Meanwhile, the US Drug Enforcement Agency has proposed that the drug be classified as a Schedule IV product because of its potential for abuse and dependence. Merck noted it expects the therapy to be available in the US in late 2014 or early 2015, once the Drug Enforcement Agency has made its decision on the scheduling of the drug.
http://www.firstwordpharma.com/node/1230146?tsid=28&region_id=2#axzz3ANQplMs6, Published 14 August 2014

Pfizer explores IBD in pact with 23andMe.
Pfizer has linked up with personal genetics company 23andMe to explore the underlying cause of inflammatory bowel disease. The companies aim to enroll 10,000 patients with Crohn’s disease or ulcerative colitis to explore the genetic factors associated with the onset, progression, severity and response to treatments for IBD. Participants, who will receive 23andMe’s Personal Genome Service kit (including ancestry analysis and uninterpreted raw genetic data), will need to provide a DNA saliva sample, answer online surveys, and agree to share their data with researchers.Some 1.4 million people suffer from IBD in the USA and the disease accounts for an overall healthcare cost of more than $1.7 billion. Jose Carlos Gutierrez-Ramos, head of biotherapeutics R&D at Pfizer, said that “by enhancing our understanding of the underlying biology of the disease, we hope to better support our clinical research activities and development programmes”.Those programmes include studies on tofacitinib for UC (Phase III) and Crohn’s (Phase II) and two Phase II monoclonal antibodies being investigated in IBD

http://www.pharmatimes.com/Article/14-08-12/Pfizer_explores_IBD_in_pact_with_23andMe.aspx, Published 13 August 2014

Sanofi to pay up to $900m to Mannkind for share in insulin Afrezza.
Sanofi and Mannkind have signed an exclusive licensing agreement to develop and market the latter’s inhaled insulin diabetes therapy Afrezza. Sanofi and Mannkind have signed an exclusive licensing agreement to develop and market the latter’s inhaled insulin diabetes therapy Afrezza. Under the terms of the agreement, France-based Sanofi will pay Mannkind $150m upfront and make subsequent milestone payments of up to $775m. The French company will advance the payment of its share of expenses up to $175m to Mannkind. Sanofi will have a share of 65% in profits and loses while Mannkind will receive 35%. Mannkind chairman and CEO Alfred Mann said: “Our profit-sharing agreement aligns the interests of MannKind and Sanofi to optimize development, commercialization and manufacturing costs.” Afrezza is the first inhaled insulin to be approved by the US Food and Drug Administration for adults with type 1 and type 2 diabetes. Mannkind obtained the approval earlier this year. Sanofi senior vice-president diabetes division Pierre Chancel said: “Afrezza is an innovative drug-device combination product consisting of a dry formulation of human insulin delivered through a small, discreet inhaler. “It is uniquely positioned to provide patients with another insulin therapy option to manage their diabetes but does not require multiple daily injections.” The companies plan to launch Afrezza in the US in the first quarter of 2015.
http://drugdelivery.pharmaceutical-business-review.com/news/sanofi-to-pay-up-to-900m-to-mannkind-for-share-in-insulin-afrezza-4340096, Published 11 August 2014

Sanofi licenses preclinical drugs to China’s Zai Lab.
Sanofi is licensing two preclinical respiratory compounds to China’s Zai Lab.The drugs show promise as potential treatments for chronic obstructive pulmonary disease, asthma and idiopathic pulmonary fibrosis. Financial details of the deal were not disclosed but Sanofi will be eligible to receive development and regulatory milestones, plus tiered royalties. In China, according to the World Health Organisation, chronic respiratory diseases are the second leading cause of death. It is estimated that over 50% of Chinese men smoke and the worsening pollution levels is also a major contributor. Samantha Du, Zai Lab’s chief executive, said diseases such as COPD and asthma are becoming a leading cause of morbidity and mortality in China “with no effective treatments”. The Shanghai-based company has launched over half a dozen drugs globally and successfully taken five candidates into clinical trials in China.

http://www.pharmatimes.com/Article/14-08-13/Sanofi_licenses_preclinical_drugs_to_China_s_Zai_Lab.aspx, Published 13 August 2014

Sanofi’s US pharma head joins Synta as CEO.
Sanofi’s US pharma head joins Synta as CEO, Synta Pharmaceuticals has named the former head of Sanofi’s pharma operations in the US and Canada as its new CEO. Anne Whitaker served as president, North America pharmaceuticals, at Sanofi since September 2011 overseeing all pharma and consumer healthcare operations within the region. She also served as a member of Sanofi’s global leadership team, global commercial operations committee and US regional management committee. She now leads an emerging US-based biopharma focused on the development of small molecule drugs to treat patients with severe medical conditions, including cancer and chronic inflammatory diseases. “Synta presents an exciting opportunity defined by a late stage product, ganetespib, that has shown promising activity in multiple indications and a pre-clinical programme, HDC, that has significant potential to generate new drug candidates,”
http://manufacturing.pharmaceutical-business-review.com/news/fda-accepts-to-review-pfizers-bla-for-meningococcal-b-vaccine-candidate-150814-4344662, Published 15 August 2014

Sun Pharma likely to enter Japanese market in four years.
Sun Pharmaceuticals is reportedly planning to enter the Japanese market riding on its association with Daiichi Sankyo from which it is buying Ranbaxy Laboratories. The Economic Times has reported that the drug company is likely to introduce its generic drugs in Japan in three to four years after the deal with Ranbaxy is closed. The company strategy would get a push with the Japanese Government’s decision to increase the penetration of generic drugs in the country to 60% by 2017 from the current 20%. Also, Sun Pharma expects to begin recovering its research and development costs through the sale of Ranbaxy’s generic versions of Nexium and Valcyte in the US in a year after the closure of the deal. Meanwhile, the Competition Commission of India (CCI) has sought more details from Sun and Ranbaxy on their transaction to ensure that the deal does not mar competition in the pharma industry, reported Press Trust of India. A senior official told the news agency: “We have sought more information from the two companies. We will take a final view after getting the required information.” Sun signed $4 billion deal in April to buy Ranbaxy from Daiichi, to create the fifth-largest speciality generics company in the world. The sale is currently awaiting approvals from the Indian Government.
http://www.pharmaceutical-business-review.com/news/sun-pharma-likely-to-enter-japanese-market-in-four-years-110814-4339872, Published 11 August 2014

WHO panel says ethical to use unproven drugs, vaccines to fight Ebola outbreak.
The World Health Organization said Tuesday that a panel convened to assess the ethics of using experimental therapies against Ebola reached a consensus that drugs and vaccines “with as yet unknown efficacy and adverse effects” may be used to potentially treat or prevent the infection. The panel also said “more detailed analysis and discussion” are needed to decide how to prioritise the use of unregistered experimental drugs and vaccines and achieve their fair distribution due to the limited supply of the therapies.
http://www.firstwordpharma.com/node/1229835?tsid=28&region_id=6#axzz3A61R2dFw, Published 12 August 2014

NOTICIAS FARMACEUTICAS INTERNACIONALES DEL 21 DE JULIO AL 25 DE JULIO DEL 2014.

INDEX:
Actelion boosts earnings guidance following “strong” first half for Opsumit.
Allergan to cut 1500 jobs; posts Q2 rise in sales, profit.
Amgen reports positive Phase III results for AMG 416 to treat secondary hyperparathyroidism in CKD patients.
AZ inks cancer immunotherapy combo deal with Advaxis.
Boehringer, University of Toronto form alliance for new therapeutic concepts in ubiquitin biology.
Bristol-Myers enters into immuno-oncology collaboration with Ono Pharmaceutical.
FDA approves Avanir’s Phase II trial of MDD candidate AVP-786.
FDA grants Genentech’s Avastin priority review for recurrent platinum-resistant ovarian cancer.
Gilead’s Sovaldi soars with sales of $3.48 billion.
GlaxoSmithKline says growth not expected this year after Q2 sales fall 16 percent.
Merck KgAa strengthens commitment to Chinese growth market.
CEO says Roche to stick to small acquisitions, partnerships.
UCB epilepsy drug brivaracetam shines again in Phase III.
Valeant wants Allergan shareholders to see growth at Bausch & Lomb.

Actelion boosts earnings guidance following “strong” first half for Opsumit.
Actelion on Tuesday lifted its earnings forecast for the year following “strong launch momentum” for its pulmonary arterial hypertension (PAH) therapy Opsumit, which recorded 53 million Swiss francs ($59 million) in sales during the first half of 2014. “Since the product contribution has exceeded previous forecasts, we are now able to significantly upgrade our guidance for the full year,” remarked chief financial officer André C. Muller. Specifically, the company said it now expects earnings growth to be at least in the mid-teen percentage range at constant exchange rates, up from prior guidance of growth at a low single-digit percentage rate. Actelion added that it will review its 2015 forecast early next year after predicting profit growth by a single-digit percentage. For the first half, overall product sales jumped 12 percent to 993 million francs ($1.1 billion), with revenue from Tracleer rising 3 percent to 791 million francs ($878 million). Meanwhile, net income more than doubled from 199 million francs ($221 million) in the year-ago period to 420 million francs ($466 million), as the company benefited from higher prices for Tracleer, as well as over-budgeting for rebates it pays to Medicaid on the therapy. CEO Jean-Paul Clozel suggested that Opsumit will be even more successful than Tracleer, which starts to lose patent protection in 2015, in terms of sales. “Frankly I don’t think it’s a question of if, it’s a question of when,” Clozel remarked, although he declined to predict peak sales for Opsumit. The product, which was approved by the FDA and European Commission last year, has been launched in the US, Germany, Austria, Switzerland, Canada, the UK, Ireland, Denmark, Norway, Sweden and the Netherlands. Actelion indicated that further launches are planned for Australia and Italy in the second half and for France and Spain in 2015. Meanwhile, Opsumit was approved in Australia and Mexico in the first half, with the therapy also being filed in Japan. Last month, Actelion reported top-line results demonstrating that its first-in-class selective oral prostacyclin IP receptor agonist selexipag met the primary endpoint of a Phase III study in patients with PAH. The company indicated that it also expects to announce results in the second half for a number of its other experimental drugs, including the antibiotic cadazolid for Clostridium difficile-related diarrhea and ponesimod in multiple sclerosis. “We have a fantastic pipeline which is not valued or very well known, which is because we didn’t really want to describe it up until now,” Clozel remarked. Commenting on rumours that Actelion could be a potential target for US drugmakers seeking to undertake tax-inversion deals, Clozel said the company hasn’t received any takeover approaches. “For me it does not make sense to make a deal because of a tax ruling, because it’s just a short-term view,” Clozel noted, adding “we have the support of shareholders, and any person thinking of a tax inversion needs to think of that before making any decision.”
http://www.firstwordpharma.com/node/1225602?tsid=28&region_id=3#axzz3873HsuH1, Published 22 July 2014

Allergan to cut 1500 jobs; posts Q2 rise in sales, profit.
Allergan announced Monday alongside its second-quarter financial results that it will reduce its workforce by approximately 1500 employees, or around 13 percent of its current global headcount, as part of efforts to boost stockholder value. The company said that the restructuring, along with other measures, will lead to savings of about $475 million in 2015. According to Allergan, the savings “will come from efficiencies and reductions in spend across the commercial organisation, general and administrative functions, manufacturing and the research and development organisation.” The company noted that “additional strategic options are available including business development / acquisitions and capital return.” Allergan indicated that the job cuts, under which it will also eliminate approximately 250 vacant positions, follow a review of its operations, including its portfolio of R&D projects. The drugmaker said that all pharmaceutical research programmes in the clinic will continue, while any reductions in discovery programmes “will not impact approvals within the strategic plan period” through 2019. “With continuing strong momentum, Allergan recorded the strongest increase in absolute dollar sales in any quarter in our history, and again delivered sales and earnings per share growth above the high end of our expectations,” remarked CEO David E.I. Pyott. Product sales in the second quarter jumped 15.9 percent year-over-year to $1.8 billion, coming in ahead of analyst estimates, while sales of Botox rose 12.9 percent to $579.4 million. Further, net income reached $417.2 million, versus $359.9 million in the same period of last year. For the full year, Allergan said it expects total product sales of between $6.9 billion and $7.05 billion. The drugmaker also reaffirmed its target for double-digit sales growth through 2019, noting that earnings are predicted to have a compounded annual growth rate of greater than 20 percent. Specifically, Allergan estimated that earnings per share this year will be between $5.74 and $5.80, rising to between $8.20 and $8.40 next year and reaching approximately $10.00 in 2016. Allergan also reiterated the rejection of a recent takeover proposal from Valeant Pharmaceuticals comprising 0.83 common shares of Valeant and $72.00 in cash, or an equal amount of cash or number of shares of Valeant common stock. The company has concluded that the offer “is grossly inadequate, substantially undervalues Allergan [and] creates significant risks and uncertainties.” Allergan has also criticised Valeant’s business model, although the Canadian company on Monday said it contacted regulators in the US and Canada over “false and misleading statements” made by the US drugmaker.
http://www.firstwordpharma.com/node/1225366?tsid=28#axzz3873HsuH1, Published 21 July 2014

Amgen reports positive Phase III results for AMG 416 to treat secondary hyperparathyroidism in CKD patients.
Amgen has announced that a Phase III study evaluating AMG 416 (formerly known as velcalcetide) for the treatment of secondary hyperparathyroidism (SHPT) in patients with chronic kidney disease (CKD), receiving hemodialysis, met its primary and all secondary endpoints. The primary endpoint was the proportion of patients with > 30 percent reduction from baseline in parathyroid hormone (PTH) levels during an Efficacy Assessment Phase (EAP) defined as the period between weeks 20 and 27. Amgen obtained AMG 416 as part of the acquisition of KAI Pharmaceuticals, Inc. in July 2012 and these are the first results to be reported from the Phase III program. In the AMG 416 group, 75.3 percent of patients achieved a > 30 percent reduction from baseline in PTH compared with 9.6 percent in the placebo arm, a statistically significant result. Secondary endpoints included the percent change from baseline during the EAP in serum phosphorus (P) concentration (mean changes of -9.63 and -1.60 percent among patients in the AMG 416 and placebo arms, respectively) and corrected calcium (cCa) concentration (mean changes of -6.69 and 0.58 percent among patients in the AMG 416 and placebo arms, respectively). Both of these secondary endpoint results were statistically significant. “Secondary hyperparathyroidism can be a challenging disease to manage and control. There is an important role for an effective calcimimetic that can be administered intravenously with hemodialysis to help treat this disease,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “We are encouraged by the results of this study and look forward to sharing results from a second placebo-controlled study later this year, and a head-to-head study evaluating AMG 416 compared to cinacalcet next year.” Treatment-emergent adverse events (TEAEs) were reported in 91.7 and 81.1 percent of patients who received AMG 416 and placebo, respectively. TEAEs that were reported in > 10 percent of patients who received AMG 416 included (AMG 416 vs placebo, respectively): blood calcium decreased (66.7 and 12.0 percent), diarrhea (14.3 and 10.0 percent), and muscle spasms (11.1 and 6.2 percent). Serious adverse events (SAEs) were reported in 24.6 and 27.4 percent of patients who received AMG 416 and placebo, respectively. TEAEs of nausea were reported in 9.1 and 7.3 percent of patients who received AMG 416 and placebo, respectively. TEAEs of vomiting were reported in 7.5 and 3.1 percent of patients treated with AMG 416 and placebo, respectively. TEAEs of hypocalcemia (symptomatic) were reported in 6.7 percent of patients who received AMG 416 versus none in the placebo group. This was a 26-week, randomized, double-blind, placebo-controlled study (study number 20120230) that evaluated the efficacy and safety of AMG 416 for the treatment of SHPT in 515 patients with CKD receiving hemodialysis. Patients received AMG 416 or placebo three times per week by intravenous injection with each hemodialysis treatment. Doses ranged from a minimum of 2.5 mg to a maximum of 15 mg. Patients also received standard of care which could include calcium supplements, vitamin D sterols and phosphate binders, if prescribed by the individual physician. Secondary endpoints included the proportion of patients with PTH = 300 pg/mL during the EAP and the percent change from baseline during the EAP in values for PTH, serum cCa, corrected calcium-phosphorus product (cCa x P) and P.
http://drugdelivery.pharmaceutical-business-review.com/news/amgen-reports-positive-phase-iii-results-for-amg-416-to-treat-secondary-hyperparathyroidism-in-ckd-patients-210714-4322068, Published 21 July 2014

AZ inks cancer immunotherapy combo deal with Advaxis.
AstraZeneca has linked up with US biotech Advaxis to develop their respective cancer immunotherapies in combination. Specifically, the firms will evaluate AstraZeneca’s closely-watched PD-L1 checkpoint inhibitor MEDI4736 in a Phase I/II study with Advaxis’ cancer vaccine ADXS-HPV in patients with human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. MEDI4736, developed by AstraZeneca’s MedImmune unit, blocks a signal that helps tumours avoid detection, while ADXS-HPV enhances the ability of immune cells to combat the tumour. Preclinical evidence suggests that the combination of ADXS-HPV with a checkpoint inhibitor can enhance overall anti-tumour response. Daniel O’Connor, Advaxis chief executive claimed that this is the first time a PD-L1 checkpoint inhibitor will be used with a new class of immunotherapies, adding that “as multiple companies vie for a competitive advantage in the future PD-L1 market, the ability of our immunotherapy platform to attack multiple tumour targets makes it an attractive combination therapy”. AstraZeneca has recently initiated other immuno-oncology combination trials, including a collaboration to study MEDI4736 with Incyte’s oral indoleamine dioxygenase-1 inhibitor INCB24360.
http://www.pharmatimes.com/Article/14-07-22/AZ_inks_cancer_immunotherapy_combo_deal_with_Advaxis.aspx, Published 22 July 2014

Boehringer, University of Toronto form alliance for new therapeutic concepts in ubiquitin biology.
Germany-based Boehringer Ingelheim has entered into a research alliance with the University of Toronto through the Toronto Recombinant Antibody Centre (TRAC), together with Toronto-based University Health Network and Mount Sinai Hospital to investigate new therapeutic targets in the field of ubiquitin signalling biology. The ubiquitin system alterations are related to many common diseases, including cancer, diabetes, inflammation and several central nervous system (CNS) disorders. Scientists from Boehringer and the Toronto academic community will work together to explore different therapeutic concepts within the ubiquitin system. As part of the deal, research capabilities of the three research institutes and Boehringer will be brought together to offer new starting points for drug discovery in a multi-year research program focusing on the development and characterization of new ubiquitin binding variants developed at the TRAC. Boehringer Ingelheim Research and Non-clinical Development senior corporate vice-president Michel Pairet said the company is happy to work closely in a joint research program with the distinguished scientists at the University of Toronto, the University Health Network and the Mount Sinai Hospital in this emerging field of breakthrough therapeutics. “We believe that this research program, headed by Sachdev Sidhu at the University of Toronto, will further strengthen our strong commitment in initiating new drug discovery programmes in areas of high unmet medical need,” Pairet said.
http://contractresearch.pharmaceutical-business-review.com/news/boehringer-university-of-toronto-form-alliance-for-new-therapeutic-concepts-in-ubiquitin-biology-230714-4323946, Published 23 July 2014

Bristol-Myers enters into immuno-oncology collaboration with Ono Pharmaceutical.
Bristol-Myers Squibb (BMS) and Ono Pharmaceutical have entered into a strategic agreement to jointly develop and commercialize multiple immunotherapies as single agents and combination regimens for cancer patients in Japan, South Korea and Taiwan. Under the deal, both the firms will jointly develop and commercialize Opdivo (nivolumab) and Yervoy (ipilimumab) across a broad range of tumor types. Development costs and commercial profits will be shared equally when Opdivo is used in combination with any BMS compounds. The deal has three additional early-stage clinical immuno-oncology assets from BMS, which include lirilumab, an antibody that blocks the KIR receptor on natural killer cells, urelumab, an agonist of the CD137 co-stimulatory receptor, and BMS-986016, a LAG3 immune checkpoint inhibitor. Both the firms will jointly pursue development of monotherapy and combination regimens, with Opdivo as the foundational therapy in Japan, South Korea and Taiwan, and leverage global clinical trials by including patients from the three countries. Bristol-Myers Squibb chief executive officer Lamberto Andreotti said the collaboration with Ono supports the company’s goal to maximize the full potential of our immuno-oncology portfolio for patients worldwide. “This collaboration combines our leadership in immuno-oncology with both companies’ experience and capabilities in Asia, and strengthens our long-standing relationship with Ono,” Andreotti said. In Japan, the PD-1 immune checkpoint inhibitor ‘Opdivo’ is approved for treatment of patients with unresectable melanoma, making it the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world. Currently, Opdivo is being developed in multiple tumor types in more than 35 clinical trials. Yervoy, a CTLA-4 immune checkpoint inhibitor, is approved in Taiwan to treat patients with advanced melanoma who have received prior therapy. The drug is currently in late-stage development as a potential treatment option for melanoma, small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) in Japan.
http://drugdiscovery.pharmaceutical-business-review.com/news/bms-enters-into-immuno-oncology-collaboration-with-ono-pharmaceutical-240714-4325415, Published 24 July 2014

FDA approves Avanir’s Phase II trial of MDD candidate AVP-786.
The US Food and Drug Administration (FDA) has accepted Avanir Pharmaceuticals’ investigational new drug (IND) application for a Phase II trial evaluating the safety and efficacy of its next generation compound AVP-786. Avanir intends to start the trial by evaluating AVP-786 for the adjunctive treatment of major depressive disorder (MDD) during the third quarter of 2014. Avanir Pharmaceuticals chief medical officer Joao Siffert said the endorsement of the Phase II trial by the division of Psychiatry Products at the FDA lends support for the expedited development path for AVP-786 and is allowing it to reference the extensive data generated during AVP-923 development programs. “This is an important moment for the company, as this will be our first clinical study evaluating AVP-786 in patients,” Siffert said. “There are millions of patients with MDD who do not respond adequately to existing therapies. With a mechanism of action addressing multiple neurotransmitter systems involved in depression, AVP-786, if approved, could offer a potential new treatment option for these patients. We look forward to initiating our clinical research program in the coming months.” The submission of this IND represents the first step in the company’s plan to develop AVP-786 for a broad array of neurological and psychiatric conditions. The Phase II trial will evaluate the efficacy and safety of AVP-786 in patients suffering from MDD who have had an inadequate response to commonly prescribed antidepressants, including selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs). About 200 patients in the US will be enrolled in the multicenter, randomized, double-blind, placebo-controlled proof-of-concept trial. During the trial, eligible patients will be randomized to receive either AVP-786 or placebo for 10 weeks.
http://processandproduction.pharmaceutical-business-review.com/news/fda-approves-avanirs-phase-ii-trial-of-mdd-candidate-avp-786-220714-4322944, Published 22 July 2014

FDA grants Genentech’s Avastin priority review for recurrent platinum-resistant ovarian cancer.
Genentech, a member of the Roche Group, has announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) and granted Priority Review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer. “The majority of women with ovarian cancer will become resistant to platinum therapy and a quarter of women will have platinum-resistant disease at the time of a first recurrence. New treatment options are needed,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “We look forward to working with the FDA to bring this potential option to women with this difficult-to-treat cancer as soon as possible.” The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide “significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.” The sBLA for Avastin plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from the Phase III AURELIA trial with an FDA action date of November 19, 2014.
http://regulatoryaffairs.pharmaceutical-business-review.com/news/fda-grants-genentechs-avastin-priority-review-for-recurrent-platinum-resistant-ovarian-cancer-230714-4324611, Published 25 July 2014

Gilead’s Sovaldi soars with sales of $3.48 billion.
An excellent day for Gilead Sciences has seen the US biotech post record-breaking sales of its hepatitis C pill Sovaldi and approval in the USA for Zydelig to treat three types of blood cancer. Second-quarter group revenues leapt 135% to $6.53 billion, with net income reaching $3.66 billion, up from $772.6 million in the like, year-earlier period. Sales of Sovaldi (sofosbuvir), which costs $1,000 a pill in the USA, came in at $3.48 billion, bringing its total revenues since the beginning of the year to over $5.75 billion. Since its launch in December, Gilead chief executive John Martin noted that Sovaldi has been prescribed for more than 70,000 patients in the USA and 10,000 in Europe, “underscoring the medical community’s recognition of the benefits of this product.” He added that “we look forward to making Sovaldi available in additional countries”. Gilead faces near-constant criticism about the price of Sovaldi, which is unlikely to diminish as the revenues keep rising. However the company’s stance is that the drug represents excellent value for money given that it is actually curing people. Aside from Sovaldi, Gilead’s HIV franchise also performed well. Its once-daily, single pill Stribild – a combination of elvitegravir, cobicistat, emtricitabine and tenofovir – soared 171% to $269.5 million, although the triple combo Atripla (efavirenz/tenofovir/emtricitabine) slipped 7% to $870.7 million. Sales of Truvada (tenofovir/emtricitabine) were flat at $806.6 million. The good news continued for Gilead with the approvals from the US Food and Drug Administration for Zydelig (idelalisib). First up, the oral inhibitor of phosphoinositide 3-kinase (PI3K) delta is being granted traditional approval to treat patients whose chronic lymphocytic leukaemia has returned. Used in combination with Rituxan (rituximab), Zydelig is to be used in patients for whom the Roche drug alone would be considered appropriate. The FDA is also granting Zydelig accelerated approval to treat patients with relapsed follicular B-cell non-Hodgkin lymphoma and relapsed small lymphocytic lymphoma, another type of non-Hodgkin lymphoma. The drug is intended to be used in patients who have received at least two prior systemic therapies. Under the accelerated approval programme, companies must conduct confirmatory trials. Also, Zydelig will carry a boxed warning about the risk of serious and potentially fatal toxicities, including liver toxicity, diarrhea, colon and lung inflammation and intestinal perforation.
http://www.pharmatimes.com/Article/14-07-24/Gilead_s_Sovaldi_soars_with_sales_of_3_48_billion.aspx, Published 24 July 2014

GlaxoSmithKline says growth not expected this year after Q2 sales fall 16 percent.
GlaxoSmithKline said Wednesday alongside its second-quarter financial results that it doesn’t expect sales and profit to grow this year as previously anticipated. CEO Andrew Witty remarked “it is now unlikely that we will deliver sales growth,” while earnings per share are expected “to be broadly similar to last year.” Shares in the company fell as much as around 3 percent on the news. Witty indicated in April that sales would increase in 2014 at constant exchange rates with earnings growing between 4 percent and 8 percent. However, the executive noted Wednesday that its progress with newly launched products “is being offset by pricing and contracting pressure in the US,” which he said has “resulted in a “step change” reduction in Advair market share and pricing.” Witty added that competition to Lovaza in the US “has been more substantive and began earlier than we expected,” with Teva gaining FDA approval for its generic version of the high-dose omega-3 prescription product in April. For the second quarter, GlaxoSmithKline said that sales from its respiratory medicines declined 8 percent year-over-year on a constant exchange rate basis to 1.6 billion pounds ($2.7 billion), with revenue from Seretide/Advair down 12 percent to 1.1 billion pounds ($1.9 billion). The company noted that sales of Advair in the US slumped 19 percent on a constant exchange rate basis to 528 million pounds ($899 million). “Our strategy to transition and diversify our respiratory portfolio is underway,” remarked Witty, noting that new products, including Breo Ellipta and Anoro Ellipta, are expected to generate sales growth. GlaxoSmithKline reported that three-monthly sales from prescription drugs slipped 6 percent on a constant exchange rate basis to 3.8 billion pounds ($6.5 billion), with revenue from Lovaza plunging 81 percent versus the year-ago period to 27 million pounds ($46 million). Meanwhile, quarterly sales from the company’s vaccine unit rose 5 percent on a constant exchange rate basis to 766 million pounds ($1.3 billion). In the quarter, sales of prescription drugs and vaccines fell 10 percent on a constant exchange rate basis to 1.2 billion pounds ($2 billion), with revenue in Europe flat at 1 billion pounds ($1.7 billion). GlaxoSmithKline said that sales in emerging markets increased 11 percent on a constant exchange rate basis to 822 million pounds ($1.4 billion), although revenue in China, where the drugmaker is facing an ongoing bribery probe, declined 25 percent to 129 million pounds ($220 million).
http://www.firstwordpharma.com/node/1225958?tsid=28&region_id=6#axzz38Ibzznsl, Published 23 July 2014

GlaxoSmithKline says growth not expected this year after Q2 sales fall 16 percent.
GlaxoSmithKline said Wednesday alongside its second-quarter financial results that it doesn’t expect sales and profit to grow this year as previously anticipated. CEO Andrew Witty remarked “it is now unlikely that we will deliver sales growth,” while earnings per share are expected “to be broadly similar to last year.” Shares in the company fell as much as around 3 percent on the news. Witty indicated in April that sales would increase in 2014 at constant exchange rates with earnings growing between 4 percent and 8 percent. However, the executive noted Wednesday that its progress with newly launched products “is being offset by pricing and contracting pressure in the US,” which he said has “resulted in a “step change” reduction in Advair market share and pricing.” Witty added that competition to Lovaza in the US “has been more substantive and began earlier than we expected,” with Teva gaining FDA approval for its generic version of the high-dose omega-3 prescription product in April. For the second quarter, GlaxoSmithKline said that sales from its respiratory medicines declined 8 percent year-over-year on a constant exchange rate basis to 1.6 billion pounds ($2.7 billion), with revenue from Seretide/Advair down 12 percent to 1.1 billion pounds ($1.9 billion). The company noted that sales of Advair in the US slumped 19 percent on a constant exchange rate basis to 528 million pounds ($899 million). “Our strategy to transition and diversify our respiratory portfolio is underway,” remarked Witty, noting that new products, including Breo Ellipta and Anoro Ellipta, are expected to generate sales growth. GlaxoSmithKline reported that three-monthly sales from prescription drugs slipped 6 percent on a constant exchange rate basis to 3.8 billion pounds ($6.5 billion), with revenue from Lovaza plunging 81 percent versus the year-ago period to 27 million pounds ($46 million). Meanwhile, quarterly sales from the company’s vaccine unit rose 5 percent on a constant exchange rate basis to 766 million pounds ($1.3 billion). In the quarter, sales of prescription drugs and vaccines fell 10 percent on a constant exchange rate basis to 1.2 billion pounds ($2 billion), with revenue in Europe flat at 1 billion pounds ($1.7 billion). GlaxoSmithKline said that sales in emerging markets increased 11 percent on a constant exchange rate basis to 822 million pounds ($1.4 billion), although revenue in China, where the drugmaker is facing an ongoing bribery probe, declined 25 percent to 129 million pounds ($220 million).
http://www.firstwordpharma.com/node/1225958?tsid=28&region_id=6#axzz38Ibzznsl, Published 24 July 2014

Merck KgAa strengthens commitment to Chinese growth market.
Merck, a leading company for high-tech products in the pharmaceutical and chemical sectors, today reiterated its commitment to investments in the Chinese market, strengthening a major pillar of its emerging markets growth strategy. Merck’s Executive Board this week met in Shanghai, a month before the groundbreaking of its new pharmaceutical plant in Nantong, which from 2017 will be the Group’s second-largest pharmaceutical manufacturing facility globally. Merck currently employs more than 2,000 people at over 40 sites in China, with the most important products including Erbitux to treat cancer, Gonal-f to treat infertility as well as life science tools and liquid crystals (LC) for flat panel displays. In total, Merck has committed more than € 100 million to investments in China over that past three years. “China is of strategic importance to Merck,” said Karl-Ludwig Kley, Chairman of the Executive Board.” Together with government officials, customers, partners and our highly motivated local colleagues, we will explore ways to further address critical health care needs of the Chinese population – both with our high-quality drugs and our life science tools for biopharmaceutical R&D. We’re also meeting with customers in the display industry to continue our constant dialogue about innovative solutions to meet the needs of the ever-changing high -tech market.”
http://www.worldpharmanews.com/merckkgaa/2838-merck-strengthens-commitment-to-chinese-growth-market, Published 23 July 2014.

CEO says Roche to stick to small acquisitions, partnerships.
Roche CEO Severin Schwan said the company will continue with its focus on smaller acquisitions and partnerships rather than pursuing large deals, Finanz und Wirtschaft reported. “We’re sticking to our previous strategy. This includes targeted, small acquisitions and partnerships like the ones we have carried out in recent months,” Schwan remarked. The executive suggested that Roche isn’t interested in the potential tax advantages from large takeovers, similar to AbbVie’s proposed acquisition of Shire for about 32 billion pounds ($54.7 billion) and Mylan’s recent $5.3-billion deal to buy Abbott’s international generic-drug business. “We are certainly seeing a consolidation in the pharmaceutical industry, and my theory is that in a couple of years it will be mostly drugmakers who are either innovative or successful in making cheaper drugs who will be successful,” Schwan commented. Earlier this month, Roche agreed to buy Seragon Pharmaceuticals for $1.7 billion, but Schwan suggested that high valuations of companies “is another reason why we have been less active than we once were.” The executive noted “we take a look at everything. But at present the calculations only add up in the fewest cases.” Schwan said “we have to weigh up internal and external opportunities. It can’t be that we have to put important internal opportunities on ice because of too-expensive acquisitions.”
http://www.firstwordpharma.com/node/1225321?tsid=28&region_id=2#axzz3873HsuH1, Published 21 July 2014

UCB epilepsy drug brivaracetam shines again in Phase III.
UCB has posted positive topline results from its latest Phase III study with its epilepsy drug brivaracetam, which will provide the basis for filings on both sides of the Atlantic early next year. This study was designed to evaluate brivaracetam compared to placebo, as adjunctive treatment in adults not fully controlled despite treatment with one or two concomitant antiepileptic drugs. The results showed that brivaracetam reduced partial-onset seizure frequency and improved responder rates. UCB chief medical officer Iris Loew Friedrich said the results were consistent with previous brivaracetam trials, noting that the trial was the largest Phase III study conducted in epilepsy patients with partial-onset seizures. Overall, “the brivaracetam development programme has involved over 3,000 people and offers over eight years of clinical experience with some patients”, she added, noting that “we look forward to discussing the data with the regulatory authorities and the scientific community”. Jean-Christophe Tellier, the company’s chief executive-elect, stated that “as the newest product to emerge from our late-stage pipeline, brivaracetam is leading the way for UCB’s new era of patient-centric solutions.
http://www.pharmatimes.com/Article/14-07-23/UCB_epilepsy_drug_brivaracetam_shines_again_in_Phase_III.aspx, Published 23 July 2014

Valeant wants Allergan shareholders to see growth at Bausch & Lomb.
Valeant, which is trying to overcome resistance from the management of Allergan for its $53 billion buyout offer, has filed a new presentation with the SEC in preparation for an investor meeting. Refuting Allergan’s contention that its growth has been mostly tied to its nonstop M&A action, Valeant says the data shows 12% organic growth at Bausch & Lomb since it bought it out last year and takes credit for 90% of that improvement. The announcement does not mention the thousands of employees who got the boot as a result of the merger.
http://www.fiercepharma.com/story/valeant-wants-allergan-shareholders-see-growth-bausch-lomb/2014-07-18, Published 21 July 2014

NOTICIAS FARMACEUTICAS INTERNACIONALES DEL 14 DE JULIO AL 18 DE JULIO DEL 2014.

INDEX:

Abbott, Mylan in $5.3-billion branded generics deal.
Abbott reports 2014 second quarter results.
AbbVie reaches deal to buy Shire for around 32 billion pounds.
Allergan again criticises Valeant’s business model.

AstraZeneca reveals designs for new Global R&D Centre and Corporate Headquarters in Cambridge, UK
Baxter’s BioScience sales up 7 percent in second quarter, lifted by Advate.
BI’s nintedanib gets FDA breakthrough status for IPF.
B-MS set to file PD-1 drug Opdivo for melanoma in USA.
U.S. FDA has granted Priority Review for OLYSIO in combination with sofosbuvir supplementary New Drug Application.
US priority review for Avastin in metastatic cervical cancer.
GSK and Theravance put triple COPD combo into Phase III.
Johnson & Johnson’s Q2 drug sales up 21.1 percent, boosted by new products.
J&J books 13% profit rise for second quarter.
Novartis to study two experimental Alzheimer’s disease drugs in patients without symptoms.
Pfizer says once-weekly BeneFIX cuts bleeding rate versus on-demand use in haemophilia B.
Pfizer to buy InnoPharma for up to $360 million.
Roche melanoma combo boosts disease-free survival.
Sanofi weighing sale of mature products portfolio: reports.
Teva Announces FDA Acceptance of NDA Filing for Investigational Short-Acting Beta-Agonist (SABA) Inhaler (Albuterol MDPI).

Abbott, Mylan in $5.3-billion branded generics deal.
Mylan entered a definitive agreement to acquire Abbott’s developed markets branded generics unit in an all-stock transaction valued at approximately $5.3 billion, the companies announced Monday. Mylan executive chairman Robert J. Coury remarked “the acquisition of this business is absolutely the right next strategic transaction for Mylan as it builds on our strong momentum [and] expands and further diversifies our business in our largest markets outside of the US.” According to Mylan, the deal includes more than 100 of Abbott’s specialty and branded generic drugs across the therapeutic areas of cardio/metabolic, gastrointestinal, anti-infective/respiratory, CNS/pain and women’s and men’s health. Mylan indicated that the products, which include Creon, Influvac, Brufen, Amitiza and Androgel, and are sold in Europe, Japan, Canada, Australia and New Zealand, are expected to provide approximately $1.9 billion in additional annual revenue. The business being acquired also includes a sales organisation of approximately 2000 staff and two manufacturing facilities in France and Japan. Mylan noted that the transaction, which has been unanimously approved by its board and is expected to close in the first quarter of 2015, will double its revenues in Europe by boosting the company’s presence in Italy, the UK, Germany, France, Spain and Portugal. The drugmaker said the deal is also expected to more than double sales in Canada and Japan, and build on Mylan’s business in Australia and New Zealand. Mylan added that the purchase will also give it “a meaningful presence” in the specialty and branded generics market in Central and Eastern Europe. JPMorgan Chase & Co. analyst Michael Weinstein said the agreement could be a win for both companies. Weinstein noted that Abbott will get cash for its eroding European drug business and raise the growth prospects of its remaining units, while Mylan will get a lower tax rate. Sources recently suggested that the companies were in late-stage negotiations regarding a transaction. Under the deal, Abbott will transfer the assets to a new public company organised in the Netherlands, with Mylan subsequently merging with the new entity. Abbott will receive 105 million shares of the new company, representing an ownership stake of around 21 percent. Mylan noted that it will continue to be led by its current leadership team and maintain its headquarters in Pittsburgh, PA. Abbott CEO Miles D. White said that following the transaction, the company’s remaining “branded generics pharmaceuticals business will focus on emerging markets, where demographic changes and increasing access to healthcare are expected to drive sustainable growth.” The company noted that its retained branded generics business generated revenue of $2.9 billion in 2013 and is expected to have sales growth in the upper-single to double digits. Abbott added that it “does not expect to be a long-term shareholder in Mylan,” and will use the proceeds from the transaction for “opportunities that would be accretive to earnings over time.”
http://www.firstwordpharma.com/node/1223984?tsid=28#axzz37SHyuy2E, Published 14 July 2014

Abbott reports 2014 second quarter results.
Abbott today announced financial results for the second quarter ended June 30, 2014. Ongoing diluted EPS was $0.54 in the second quarter, representing growth of 17.4 percent, and above the previous guidance range of $0.50 to $0.52; reported diluted EPS from continuing operations under GAAP was $0.30. Abbott is raising its full-year 2014 ongoing EPS guidance to $2.19 to $2.29 from $2.16 to $2.26, reflecting double-digit growth at the mid-point of the range. Projected full-year 2014 EPS from continuing operations under GAAP is $1.16 to $1.26. Guidance for both ongoing and GAAP EPS from continuing operations includes the developed markets branded generics pharmaceuticals business, which is expected to be reported as discontinued operations starting in the third quarter of 2014. Second-quarter worldwide sales increased 3.0 percent on an operational basis and 1.9 percent on a reported basis, including an unfavorable 1.1 percent effect of foreign exchange. On July 14, 2014, Abbott announced that it will sell its developed markets branded generics pharmaceuticals business to Mylan. This transaction is expected to positively impact Abbott’s 2015 sales and earnings-per-share growth rates as the company focuses its branded generics pharmaceuticals business on emerging markets. In the second quarter, Abbott announced agreements to acquire Latin American pharmaceutical company, CFR Pharmaceuticals and Russian pharmaceutical company, Veropharm. CFR Pharmaceuticals will more than double Abbott’s branded generics presence in Latin America. Through the acquisition of Veropharm, Abbott will immediately establish a larger footprint and manufacturing presence in Russia. On July 10, 2014, Abbott and Fonterra announced a strategic alliance to develop a proposed dairy farm hub in China, establishing direct ownership and operation of dairies and production of milk inChina. “We’re ahead of our expectations through the first half of the year and are raising our EPS guidance range as we continue to shape the company for long-term growth,” said Miles D. White, chairman and chief executive officer, Abbott.
http://abbott.mediaroom.com/2014-07-16-Abbott-Reports-Second-Quarter-2014-Results, Published 16 July 2014

AbbVie reaches deal to buy Shire for around 32 billion pounds.
AbbVie reached an agreement to acquire Shire for 52.48 pounds ($89.80) per share, or about 32 billion pounds ($54.7 billion), the companies announced Friday. The deal, which represents a premium of 53 percent to the Irish drugmaker’s closing share price on May 2, the day before AbbVie’s initial proposal was made, comprises 24.44 pounds ($41.82) in cash and 0.8960 shares of new AbbVie per Shire share. Commenting on the transaction, AbbVie CEO Richard A. Gonzalez said the combination will create “a unique, diversified biopharmaceutical company,” adding that “the combined company would benefit from a best-in-class product development platform, a stronger pipeline and more enhanced R&D capabilities.” Meanwhile, Shire chairman Susan Kilsby remarked “we believe that the combined group represents an exciting fit of two complementary businesses that will create a new market leader in specialty pharmaceuticals,” including in immunology, rare diseases, neuroscience, metabolic diseases and liver disease. Along with Shire’s drugs for attention deficit disorder, which include Vyvanse (lisdexamfetamine) and Adderall XR (amphetamine/dextroamphetamine), AbbVie will gain a number of therapies for rare diseases through the acquisition. Shire markets Elaprase (idursulfase) for Hunter syndrome and Replagal (agalsidase alfa) to treat Fabry disease, while it is developing the experimental drugs lifitegrast for dry eye and Premiplex for the prevention of retinopathy of prematurity.
http://www.firstwordpharma.com/node/1225107?tsid=28#axzz37pNPhEms, Published July 18 2014

Allergan again criticises Valeant’s business model.
Allergan on Monday reiterated its concerns over suitor Valeant Pharmaceuticals’ business model, highlighting the latter’s “anaemic organic growth driven by unsustainable price increases, among other fundamental…issues.” Allergan made its claims as the company attempts to resist Valeant’s takeover efforts after the latter drugmaker’s decision to initiate an exchange offer taking itsMay 30 proposal, valued at approximately $53.8 billion, directly to shareholders. In an investor presentation filed with the US Securities and Exchange Commission, Allergan also raised doubts about Valeant’s commitment to transparency and the performance of its acquisitions of Separately, Valeant on Monday disclosed that it had filed a premerger notification with the US Federal Trade Commission regarding its proposed acquisition of Allergan.
http://www.firstwordpharma.com/node/1224049?tsid=28&region_id=2#axzz37SHyuy2E, Published 15 July 2014

AstraZeneca reveals designs for new Global R&D Centre and Corporate Headquarters in Cambridge, UK

AstraZeneca today revealed the proposed designs for its new Global R&D Centre and Corporate Headquarters in Cambridge in the UK. The plans for the new facility, which will be located on the Cambridge Biomedical Campus (CBC), include designs for the Global Centre, an R&D Enabling Building and an Energy Centre. Mene Pangalos, Executive Vice President, Innovative Medicines & Early Development at AstraZeneca said: “We are very excited to be able to reveal the plans for our new site in Cambridge today. Our aim is to create an open, welcoming and vibrant centre that will inspire our teams and partners to push the boundaries of scientific innovation.” The new site will bring together AstraZeneca’s small molecule and biologics research and development activity, opening up opportunities to exploit the promise of biologics and small molecule combinations. The CBC will be the new UK home for biologics research and protein engineering carried out by MedImmune, AstraZeneca’s biologics arm.

http://www.worldpharmanews.com/astrazeneca/2833-astrazeneca-reveals-designs-for-new-global-rad-centre-and-corporate-headquarters-in-cambridge-uk, Published 18 July 2014

Baxter’s BioScience sales up 7 percent in second quarter, lifted by Advate.
Baxter announced Thursday that second-quarter sales from its BioScience unit rose 7 percent year-over-year to $1.8 billion, boosted by double-digit growth for Advate. The company’s overall revenue grew 16 percent to $4.3 billion, while net income reached $520 million, versus $590 million in the year-ago period, hit by charges of $172 million. CEO Robert L. Parkinson remarked “we are driving solid performance across our entire business portfolio, and advancing care across our key franchises in both developed and emerging markets.” He added that the company has made “marked progress towards our separation into two leading healthcare companies,” remaining “on track to complete the separation by mid-year 2015.” Baxter said that for the full year, it now expects sales growth of 10 percent to 11 percent, versus an earlier estimate of 9 percent to 10 percent. Earnings are forecast to be in the range of $5.10 per share to $5.20 per share, revised from a previous prediction of $5.05 per share to $5.25 per share.
http://www.firstwordpharma.com/node/1224910?tsid=28&region_id=6#axzz37SHyuy2E, Published 17 July 2014

BI’s nintedanib gets FDA breakthrough status for IPF.
Boehringer Ingelheim’s nintedanib has been awarded breakthrough therapy designation by the US Food and Drug Administration as a treatment for idiopathic pulmonary fibrosis. IPF, a serious and life-threatening disease that causes permanent scarring of the lungs, affects as many as 132,000 Americans and there are currently no FDA-approved treatments. However, that situation is likely to change in the near future given that nindetanib was filed earlier this month with the agency, five weeks after InterMune’s rival IPF product Esbriet (pirfenidone) was resubmitted to the FDA, having been rejected in May 2010. Sabine Luik, head of medicine and regulatory affairs at Boehringer’s US pharmaceuticals unit, said that getting breakthrough designation “will help expedite its development and review as a potential treatment option for patients with IPF”. The tyrosine kinase inhibitor has already been granted a priority review (in June 2014) and fast-track designation a year earlier.
http://www.pharmatimes.com/Article/14-07-17/BI_s_nintedanib_gets_FDA_breakthrough_status_for_IPF.aspx, Published 17 July 2014

B-MS set to file PD-1 drug Opdivo for melanoma in USA.
Bristol-Myers Squibb will be filing its much-touted PD-1 checkpoint inhibitor nivolumab in the near future in the USA as a treatment for melanoma. The US major says that following discussions with the US Food and Drug Administration, it is planning a third-quarter submission of Opdivo (nivolumab) for previously-treated advanced melanoma. This will be the second tumour type for which B-MS has filed for Opdivo across the pond, having initiated a rolling submission with the FDA in third-line pre-treated squamous cell NSCLC in April; it expects to complete that particular filing by year-end. The melanoma filing, which will come considerably earlier than expected, is based on data from Checkmate -037, a Phase III trial evaluating Opdivo compared to dacarbazine or carboplatin/paclitaxel in patients with unresectable or metastatic melanoma who have been previously treated with B-MS’ own licensed drug Yervoy (ipilimumab) and, if BRAF-mutation positive, a BRAF inhibitor regimen. Last month, the company stopped another Phase III study assessing nivolumab in melanoma after independent regulators found it showed a superior survival benefit over dacarbazine. In 2013, the FDA granted fast-track designation for Opdivo in NSCLC, melanoma and renal cell carcinoma and in May this year gave the drug breakthrough therapy designation for the treatment of patients with Hodgkin lymphoma. Last week, it was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world after Japan gave the green light to Opdivo, which was filed by B-MS partner Ono Pharmaceutical Co. Nivolumab will compete with Merck & Co’s PD-1 checkpoint inhibitor pembrolizumab, which has already been filed on both sides of the Atlantic, and has a Prescription Drug User Fee Act date of October 28. A number of other of companies are exploring the PD-1 class, notably Roche and AstraZeneca.
http://www.pharmatimes.com/Article/14-07-10/B-MS_set_to_file_PD-1_drug_Opdivo_for_melanoma_in_USA.aspx#ixzz37SO3IHUi, Published 14 July 2014

U.S. FDA has granted Priority Review for OLYSIO in combination with sofosbuvir supplementary New Drug Application.
Medivir AB announces that the Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) for the use of once-daily Olysio (simeprevir) in combination with sofosbuvir for 12 weeks treatment of adult patients with genotype 1 chronic hepatitis C. The sNDA was filed in May by Medivir’s strategic partner Janssen Research & Development LLC. The regulatory submission for Olysio and sofosbuvir is supported by data from the phase II COSMOS study which included treatment-naïve patients with advanced fibrosis (METAVIR F3 to F4 scores) and prior null-responder patients with all stages of liver fibrosis (METAVIR F0 to F4 scores). “The Priority Review designation by the FDA shows the high priority and great importance of making interferon-free treatment regiments available to the many difficult to cure hepatitis C patients groups”, says Charlotte Edenius, EVP Development, Medivir.
http://www.firstwordpharma.com/node/1224326?tsid=28&region_id=3#axzz37SHyuy2E, Published 15 July 2014

US priority review for Avastin in metastatic cervical cancer.
Regulators in the USA have granted a priority review to Roche’s blockbuster Avastin in another indication, this time for cervical cancer. Specifically, the US Food and Drug Administration has accepted the company’s supplemental Biologics License Application and granted priority review for Avastin (bevacizumab) plus chemotherapy for the treatment of women with persistent, recurrent or metastatic cervical cancer. This means that the Prescription Drug User Fee Act (PDUFA) date is October 24. The filing is based on a 452-patient Phase III trial which showed that Avastin improved overall survival with a statistically significant 29% reduction in the risk of death for women who received Avastin plus chemotherapy compared to those on chemo alone (median OS: 17.0 months versus 13.3 months). They also lived longer without disease worsening, i.e. progression free survival of 8.2 months vs 5.9 months. Sandra Horning, Roche’s chief medical officer, said that this regulatory application for Avastin is important “because chemotherapy is the only approved treatment for women with metastatic, recurrent or persistent cervical cancer”. The drug is already approved in the USA for a variety of cancers, notably colorectal, lung and kidney. In March, NHS England added Avastin to the country’s Cancer Drugs Fund for Advanced cervical cancer.
http://www.pharmatimes.com/Article/14-07-15/US_priority_review_for_Avastin_in_metastatic_cervical_cancer.aspx, Published 16 July 2014

GSK and Theravance put triple COPD combo into Phase III.
GlaxoSmithKline and partner Theravance have begun a Phase III trial looking at a triple therapy for chronic obstructive pulmonary disease. The study will evaluate a once-daily ‘closed’ triple combination of the corticosteroid fluticasone furoate, umeclidinium, a long-acting muscarinic antagonist and vilanterol, a long-acting beta2- agonist. The 10,000-patient trial will investigate whether the FF/UMEC/VI combo, delivered through GSK’s Ellipta inhaler, can reduce the annual rate of moderate and severe exacerbations compared with two of the company’s already-approved once-daily COPD treatments, Relvar/Breo (FF/VI) and Anoro Ellipta (UMEC/VI) Dave Allen, head of respiratory R&D at GSK, said that “we recognised the need to offer a range of molecules that could be co-formulated in different combinations to meet the needs of individual patients”. Furthermore, “we know from the scientific literature and prescribing data that there are already COPD patients who receive three medicines in different inhalers, for whom a once-daily treatment in a single ‘closed’ device could be valuable”. Dr Allen concluded by saying that the study, called IMPACT, will be important in advancing our understanding of how the combination of FF/UMEC/VI could be used in this setting when compared to dual combination therapy options”. In the highly competitive COPD market, having a triple therapy delivered in as single device would significantly strengthen GSK’s already-strong position in this area.
http://www.pharmatimes.com/Article/14-07-16/GSK_and_Theravance_put_triple_COPD_combo_into_Phase_III.aspx, Published 16 July 2014

Johnson & Johnson’s Q2 drug sales up 21.1 percent, boosted by new products.
Johnson & Johnson reported Tuesday that second-quarter sales of prescription drugs jumped 21.1 percent year-over-year to $8.5 billion, boosted by new products including Olysio, Xarelto and Zytiga. The company’s overall revenue in the three-month period rose 9.1 percent to $19.5 billion, topping analyst estimates of just under $19 billion, while profit increased 12.9 percent to $4.3 billion. Sales of prescription drugs in the US surged 36.6 percent versus the year-ago quarter to $4.6 billion, while revenue outside the country increased 6.8 percent to $3.9 billion. Johnson & Johnson said that quarterly sales of the hepatitis C treatment Olysio, which was approved by the FDA in November last year, reached $831 million, versus $354 million in the first quarter. “Our strong second-quarter results reflect the continued success of our new product launches and the progress we have made in achieving our near-term priorities,” commented CEO Alex Gorsky. For the full year, Johnson & Johnson lifted its earnings guidance and now expects earnings of $5.85 per share to $5.92 per share, compared with a prior forecast of $5.80 per share to $5.90 per share.
http://www.firstwordpharma.com/node/1224293?tsid=28&region_id=6#axzz37SHyuy2E, Published 15 July 2014
J&J books 13% profit rise for second quarter.
Johnson & Johnson has seen its profit jump 13% for the second quarter on the back of strong sales of its new -generation medicines. The healthcare giant beat expectations with earnings of $4.3 billion for the period, compared to $3.8 billion posted a year ago. Excluding special items, earnings per share came in at $1.66, up 12.2%.The rise was largely driven by a sales increase of 9.1% to $19.5 billion which, in turn, was driven by solid performances by new drugs in its pharma segment. Worldwide pharmaceutical sales topped $8.5 billion, marking enviable growth of 21.1%, helped by turnover of: the chronic hepatitis C drug Olysio/Sovriad (simeprevir), which hit $831 million; the blood thinner Xarelto (rivaroxaban), rocketing 91% to $361 million; and prostate cancer drug Zytiga (abiraterone acetate), up 42% at $562 million, among others. It was also noted that the US Food and Drug Administration has assigned a priority review designation to the firm’s supplemental New Drug Application for the use of Olysio in combination with Gilead Science’s gamechanger HCV drug Sovaldi (sofosbuvir). On the downside, sales of attention deficit hyperactivity disorder (ADHD) drug Concerta (methylphenidate HCI) fell 33% to $145 million as generic competition continued to bite. Elsewhere, worldwide consumer sales were also up, albeit by a smaller magnitude of 2.4% to $3.7 billion, which includes a currency drag of 1.2%.
http://www.pharmatimes.com/Article/14-07-15/J_J_books_13_profit_rise_for_second_quarter.aspx, Published 16 July 2014

Novartis to study two experimental Alzheimer’s disease drugs in patients without symptoms.
Novartis announced Tuesday plans to conduct a clinical study in collaboration with Banner Alzheimer’s Institute (BAI) to determine whether two of the company’s experimental anti-amyloid treatments can prevent or delay the emergence of symptoms of Alzheimer’s disease in people at genetic risk for developing the late-onset form of the condition. David Epstein, head of Novartis Pharmaceuticals, noted that “there is a huge unmet need for treatments that prevent or delay the development of the disease and we are excited about taking research in Alzheimer’s to the next level.” The trial, which is expected to start next year, will include more than 1300 cognitively healthy adults, aged 60 to 75, who have inherited two copies of the APoE4 allele, a gene that is known to raise the risk of developing Alzheimer’s disease. Patients in the study will receive either an active immunotherapy that triggers the production of natural antibodies against amyloid, a BACE inhibitor designed to prevent the production of different forms of amyloid or placebo. The active immunotherapy is given via an injection and is in Phase II development, while the oral BACE inhibitor is about to enter Phase I trials. Novartis noted that the aim of the study is to assess whether the therapies can prevent, slow or delay the loss of memory and other cognitive abilities associated with Alzheimer’s disease. Michael Ryan, vice president at Novartis Pharmaceuticals, suggested that since only about 2 percent of the global population have two copies of the ApoE4 gene, the study could take over a year to recruit. Ryan added that the trial, which will be conducted in North America and Europe pending government approval, could take up to nine years to show results.
http://www.firstwordpharma.com/node/1224176?tsid=28&region_id=2#axzz37SHyuy2E, Published 15 July 2014

Pfizer says once-weekly BeneFIX cuts bleeding rate versus on-demand use in haemophilia B.
Pfizer announced Wednesday that a Phase III study of BeneFIX (nonacog alfa) as a prophylaxis regimen for people with moderately severe to severe haemophilia B met its primary endpoint. The company noted that top-line results showed that patients taking once-weekly BeneFIX had a significant reduction in the annualised bleeding rate versus those given on-demand treatment with BeneFIX. “These results are important because they add to the growing body of clinical evidence showing that prophylaxis treatment has the potential to reduce the number of bleeds in a year, the most critical factor in haemophilia management,” commented Steven J. Romano, Medicines Development Group Head, Global Innovative Pharmaceuticals at Pfizer.

http://www.firstwordpharma.com/node/1224587?tsid=28&region_id=6#axzz37SHyuy2E, Published 16 July 2014

Pfizer to buy InnoPharma for up to $360 million.
Pfizer entered into an agreement to buy pharmaceutical development company InnoPharma for an upfront cash payment of $225 million, with up to $135 million of contingent milestone payments, the companies announced Wednesday. Pfizer Global Established Pharma group president John Young remarked that the acquisition “is an important milestone as we continue to look for innovative growth opportunities for our sterile injectables portfolio, which will increase to 73 products with this acquisition.” InnoPharma develops novel formulations of existing drugs, “including hard-to-make products,” in areas such as cancer and central nervous disorders. InnoPharma’s current portfolio includes 10 FDA approved generic products, along with a pipeline of 19 products filed with regulator and “more than 30 injectable and ophthalmic products under development,” the companies added. The transaction is expected to close in the third quarter. Also on Wednesday, Pfizer announced that a Phase III study of BeneFIX (nonacog alfa) as a prophylaxis regimen for people with moderately severe to severe haemophilia B met its primary endpoint
http://www.firstwordpharma.com/node/1224662?tsid=28&region_id=2#axzz37SHyuy2E, Published 17 July 2014

Roche melanoma combo boosts disease-free survival.
Patients with a particular form of melanoma taking a combination of Roche’s cobimetinib (being developed with Exelixis) and Zelboraf (vemurafenib) lived significantly longer without their disease worsening than those taking the latter alone, trial results show. While keeping specific data under wraps for now, the Swiss drug giant said that the international, randomised, double-blind, Phase III CoBRIM study met its primary endpoint in showing improved progression-free survival. The trial, which pitted the two regimens against each other in 495 patients with unresectable, locally-advanced, previously untreated metastatic melanoma carrying a mutation called BRAF V600, “support the potential combined use of cobimetinib with Zelboraf to block tumour growth longer than Zelboraf alone,” noted Sandra Horning, Chief Medical Officer and Head of Global Product Development. The two-pronged approach sees cobimetinib selectively block the activity of the protein MEK 2, which is involved in regulating cell division and survival, and Zelboraf bind to mutant BRAF, another protein on the pathway, to interrupt abnormal signalling that fuel tumour growth. More than 232,000 people worldwide are currently diagnosed with melanoma each year, of which around half will be carrying the BRAF mutation. Data from the trial will be presented at an upcoming medical meeting, said Roche.
http://www.pharmatimes.com/Article/14-07-14/Roche_melanoma_combo_boosts_disease-free_survival.aspx, Published 15 July 2014

Sanofi weighing sale of mature products portfolio: reports.
According to reports on Wednesday, Sanofi has held talks with Mylan, Abbott and private-equity firms about a possible sale of its mature products portfolio for up to 6.3 billion euros ($8.5 billion). Jack Cox, a spokesman for the French drugmaker, said that no decision has yet been made on the portfolio of products. Sanofi is considering whether to sell, carve out or create a joint venture for the portfolio of 200 mature drugs, which include Plavix (clopidogrel) and had combined annual sales of about 2.1 billion euros ($2.8 billion). Reports said the plan, dubbed “Phoenix,” was detailed in an internal document presented to the company’s investment committee on May 6. Earlier this week, Mylan announced a deal valued at approximately $5.3 billion to acquire Abbott’s branded generics business in developed markets including Europe, Japan, Canada, Australia and New Zealand.
http://www.firstwordpharma.com/node/1224610?tsid=28&region_id=4#axzz37SHyuy2E, Published 16 July 2014

Teva Announces FDA Acceptance of NDA Filing for Investigational Short-Acting Beta-Agonist (SABA) Inhaler (Albuterol MDPI).
Teva Pharmaceuticals Industries Ltd. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s new drug application (NDA) for albuterol multi-dose dry-powder inhaler (MDPI), an investigational breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older. “We are extremely pleased the FDA has accepted for review the NDA for albuterol MDPI. If approved, albuterol MDPI would become the first breath-actuated dry-powder symptomatic and rescue inhaler available to asthma patients,” said Tushar Shah, MD, Senior Vice President, Teva Global Respiratory Research and Development. “As the current market-leader in asthma rescue inhalers, it is our hope that the new dry-powder innovation utilized with albuterol MDPI will help fill an unmet need in the existing asthma market.” The NDA filing includes data from eight clinical studies that evaluated the safety and efficacy of albuterol MDPI in adults and adolescents (12 years of age and older) with asthma and exercise-induced bronchospasm (EIB). The NDA for albuterol MDPI has been accepted by the FDA for standard review, with a FDA Regulatory Action expected in March 2015.
http://www.firstwordpharma.com/node/1224052?tsid=28&region_id=4#axzz37SHyuy2E, Published 14 July 2014

NOTICIAS FARMACEUTICAS INTERNACIONALES DEL 7 DE JULIO AL 11 DE JULIO DEL 2014.

INDEX:

AbbVie lifts offer to acquire Shire by 11 percent to about $51.5 billion.
Allergan looks to boost profit with cost cuts, pipeline review to ward off Valeant: report.
AstraZeneca and Max Planck Institute announce research agreement.
Bristol-Myers Squibb’s combination drug for Hepatitis C treatment gets Japanese approval.
Bristol-Myers Squibb plans third-quarter FDA filing for Opdivo.
European Commission grants marketing approval for GSK and Genmab’s Arzerra.
Lilly enters into China diabetes pact with Yabao.
Santen closes asset purchase agreement with Merck and Co. for ophthalmology assets.
Novartis leukaemia bags breakthrough status in USA.
Novartis accused again of kickback tactics in new whistleblower suit.
CliniWorks, Pfizer to develop population health management platform.
Roche’s lung cancer drug alectinib gets approval in Japan.
Sanofi’s marketing application for basal insulin Toujeo, gets FDA approval.
Sanofi/Regeneron’s dupilumab succeeds for skin disorder.
Sanofi dengue vaccine shows promise.
Teva’s oral contraceptive Seasonique gets CHMP recommendation of approval.
UCB, Dermira to develop and commercialize Cimzia in dermatology.
Valeant Pharmaceuticals Completes Sale Of Filler And Toxin Assets To Galderma.

AbbVie lifts offer to acquire Shire by 11 percent to about $51.5 billion.
AbbVie on Tuesday raised its offer to acquire Shire to 51.15 pounds ($87.56) per share, representing an increase of approximately 11 percent, or around 3 billion pounds ($5.1 billion), to its previously rejected bid of 46.26 pounds per share ($79.19), or about 27 billion pounds ($46 billion). Shire said that its board will meet to consider the revised proposal. According to AbbVie the new proposal includes 22.44 pounds ($38.41) in cash and 0.8568 ordinary shares for each Shire share, representing an increase of 2.00 pounds ($3.42) and approximately 10 percent in cash. The US company added that the revised offer, which is worth about 30.1 billion pounds ($51.5 billion), increases the ownership that will be held by Shire shareholders to approximately 24 percent of the combined group. AbbVie CEO Richard Gonzalez, who noted that the company talked with Shire’s top 20 shareholders before making its latest bid, remarked that the drugmaker “has made a compelling offer…that creates immediate and long-term value to shareholders of both companies.” Analysts suggested last month that AbbVie would likely need to increase its takeover offer to about 51 pounds ($87.30) per share in order to acquire Shire. However, Ori Hershkovitz of Sphera Funds Management said that AbbVie may need to pay 55 pounds ($94.16) a share to get Shire’s board to agree to sell. The Irish drugmaker had rejected AbbVie’s earlier bid as it “fundamentally undervalued” the company, particularly its prospects in rare diseases and specialty markets. Gonzalez remarked “this transaction is a combination of two leading companies with leadership positions in specialty pharmaceuticals that would create a global market leader with unique characteristics and a compelling investment thesis.” He added that “AbbVie will bring greater financial strength and R&D experience to this combination that will enable both companies to reach their full potential for their shareholders.” AbbVie said it “strongly encourages shareholders” to consider the proposal and communicate their perspective to Shire’s board by July the 18th.
http://www.firstwordpharma.com/node/1223010?tsid=28#axzz36tGm6jCA, Published 8 July 2014

Allergan looks to boost profit with cost cuts, pipeline review to ward off Valeant: report.
According to people close to the matter, Allergan plans to cut costs and end development of some pipeline compounds in an effort to boost profit and lift forecasts, Bloomberg reported Wednesday. Allergan, which sources noted will also overhaul management incentives, is trying to convince shareholders that the company has better prospects as a standalone business as it looks to fend off a takeover attempt from Valeant Pharmaceuticals and William Ackman’s Pershing Square Capital Management. Last month, Allergan CEO David Pyott indicated that the company would provide a more detailed plan including cost reductions when it released its second-quarter earnings at the end of July. The people said that Allergan along with cost cuts, which will include some legacy expenses, the company plans to tie management compensation more closely to achieving higher forecasts. The sources added that Allergan has also considered strategic options including an acquisition that would add growth product lines or buying back shares to appease investors and avoid being bought by Valeant. Allergan, which has rejected Valeant’s takeover offers, including the most recent comprising $72.00 in cash and 0.83 Valeant common shares, has faced criticism from the Canadian company and Pershing Square. Earlier this week, Pershing Square proposed a slate of six nominees for Allergan’s board of directors ahead of a planned special shareholder meeting that will include a vote on the drugmaker’s board.
http://www.firstwordpharma.com/node/1223107?tsid=28&region_id=2#axzz36tGm6jCA, Published 9 July 2014

AstraZeneca and Max Planck Institute announce research agreement.
AstraZeneca today announced an agreement with the Max Planck Institute of Molecular Physiology (MPI), Germany, to establish a ‘satellite unit’ in cardiovascular and metabolic disease (CVMD), linked to AstraZeneca’s CVMD Innovative Medicines unit (iMed) in Mölndal, Sweden, to study new modalities chemistry. The new collaboration will see AstraZeneca scientists working side-by-side with researchers from the Max Planck Institute of Molecular Physiology, in the Department of Chemical Biology, led by Professor Herbert Waldmann. The satellite unit will focus on novel chemistry and chemical biology in areas of new modality chemistry such as stabilised peptides, macrocycles and conjugation chemistry. Marcus Schindler, Vice President and Head of CVMD iMed, AstraZeneca, said: “I’m very pleased to collaborate with an internationally recognised academic institution such as the Max Planck Institute of Molecular Physiology. Based on our excellent ongoing collaboration with Professor Waldmann’s group and the interdisciplinary Chemical Genomics Centre, we are confident that this innovative new partnership will result in exciting scientific findings, addressing chemical challenges primarily in the field of new modalities.” Professor Herbert Waldmann, Director of the Department of Chemical Biology, MPI Dortmund, said: “This novel concept for a strategic alliance between an innovation-driven pharmaceutical company and a leading biomedical institute like the Max Planck Institute of Molecular Physiology promises to break new ground for drug discovery. AstraZeneca is one of the leading global pharmaceutical companies and we are pleased and very much looking forward to the collaboration. Uniting our strengths will give rise to novel innovative approaches to drug discovery.” Cardiovascular and metabolic diseases represent one of AstraZeneca’s three core therapeutic areas, with the aim of developing innovative treatments that address the underlying biology to stop, reverse or cure diseases with high unmet medical need. The collaboration with the Max Planck Institute will support identification of new targets in the company’s three areas of research focus in CVMD: cardiac regeneration, islet health (diabetes) and diabetic nephropathy. In March 2013 AstraZeneca initiated a similar collaboration with the Swedish medical university Karolinska Institutet that created an Integrated Translational Research Centre (ICMC) for cardiovascular and metabolic disease and regenerative medicine located at Karolinska Institutet’s site in Stockholm, Sweden. The ICMC conducts preclinical and clinical studies aimed at advancing the understanding of cardiovascular and metabolic disease pathophysiology and assessing new drug targets for AstraZeneca’s two biotech units, the iMed and MedImmune.
http://www.worldpharmanews.com/astrazeneca/2822-astrazeneca-and-max-planck-institute-announce-research-agreement, Published 9 July 2014

Bristol-Myers Squibb’s combination drug for Hepatitis C treatment gets Japanese approval.
Bristol-Myers Squibb (BMS) has received approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for Daklinza (daclatasvir) and Sunvepra (asunaprevir), as a new treatment that can lead to cure for many patients with genotype 1 chronic hepatitis C virus (HCV) infection in Japan. Daklinza is a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), while Sunvepra is a NS3/4A protease inhibitor. Currently there are no treatment options for this disease in Japan, and the combination drug is the country’s first all-oral, interferon- and ribavirin-free treatment regimen for patients with genotype 1 chronic HCV infection, including those with compensated cirrhosis. Hiroshima University lead study investigator Kazuaki Chayama said Japan has a unique hepatitis C patient population, many of whom are older and have been unable to take, or respond to, traditional therapies, so we have a real sense of urgency to treat these patients now. “The approval of the Daklinza+Sunvepra Dual Regimen offers for the first time a treatment option that addresses many of the unmet needs for our HCV patients,” Chayama said. Bristol-Myers Squibb chief executive officer Lamberto Andreotti said the approval of Daklinza+Sunvepra in Japan reflects the company’s strategic focus on developing a treatment option that meets the needs of the Japanese HCV patient population. “This milestone underscores the company’s commitment to delivering innovative medicines to patients with the highest unmet needs, and we believe Daklinza-based regimens will play a significant role in the evolution of HCV treatment for patients in Japan, and globally,” Andreotti said.
http://regulatoryaffairs.pharmaceutical-business-review.com/news/bristol-myers-squibbs-combination-drug-for-hepatitis-c-treatment-gets-japanese-approval-080714-4312262, Published 8 July 2014
Bristol-Myers Squibb plans third-quarter FDA filing for Opdivo.
Bristol-Myers Squibb stated Thursday that the company intends to apply for FDA approval of Opdivo (nivolumab) in the third quarter for the treatment of patients with previously treated advanced melanoma. The planned submission marks the second tumour type for which a US regulatory filing is under way for the experimental PD-1 immune checkpoint inhibitor. The drugmaker indicated it has already held discussions with the FDA about the filing, and Michael Giordano, who heads oncology development at Bristol-Myers Squibb, said “we continue to collaborate closely” with the regulator on Opdivo. The application will be supported by data from the ongoing Phase III Checkmate-037 study testing Opdivo against either dacarbazine or carboplatin and paclitaxel in patients with unresectable or metastatic melanoma who were previously treated with Yervoy (ipilimumab) and, if BRAF-mutation positive, a BRAF inhibitor regimen. Commenting on the news, ISI analyst Mark Schoenebaum noted that several analysts had anticipated a mid-2015 filing for the drug, though he and some other industry observers suggested the company could potentially submit its application earlier.
http://www.firstwordpharma.com/node/1223416?tsid=28&region_id=6#axzz374oezsrv, Published 10 July 2014

European Commission grants marketing approval for GSK and Genmab’s Arzerra.
The European Commission has granted marketing authorisation for GlaxoSmithKline (GSK) and Genmab’s Arzerra as first-line treatment for chronic lymphocytic leukaemia in combination with chlorambucil or bendamustine for patients ineligible for fludarabine-based therapy. The marketing authorisation is for a new indication for the use of Arzerra (ofatumumab) in combination with chlorambucil or bendamustine to treat patients with chronic lymphocytic leukaemia (CLL) who have not received prior therapy and who are not eligible for fludarabine-based therapy. Genmab CEO Jan van de Winkel said that the company is happy to receive this decision that Arzerra is approved in the EU in the front-line setting in combination with two different alkylating chemotherapies. “This is another important milestone and we look forward to a successful launch under this new indication of the drug in Europe in the coming months. We hope to receive additional approvals in frontline across the globe in the future,” Winkel added. The EC authorisation for Arzerra is based on positive data from two clinical trials, including a Phase III trial and a Phase II trial. The randomized, multicentre Phase III trial (OMB110911, COMPLEMENT 1) evaluated the combination of ofatumumab and chlorambucil versus chlorambucil alone in CLL patients. The company said that results from the open-label, parallel-arm, pivotal trial showed that the combination statistically improved median progression-free survival compared to chlorambucil alone. The Phase II trial (OMB115991) evaluated ofatumumab in combination with bendamustine in 44 patients with previously untreated CLL.
http://regulatoryaffairs.pharmaceutical-business-review.com/news/european-commission-grants-marketing-approval-for-gsk-and-genmabs-arzerra-4311023, Published 7 July 2014

Lilly enters into China diabetes pact with Yabao.
Eli Lilly has linked up with Yabao Pharmaceutical Co to develop and sell one of the US major’s early-stage diabetes drugs in China. The drug in question is a glucokinase activator (GKA), codenamed LY2608204, which has completed Phase I studies in the USA following “extensive pre-clinical development”. GKAs have the potential to differentiate from other anti-diabetic agents by promoting insulin secretion and decreasing glucose production by the liver. As a result, Yabao says these drugs may “exert powerful anti-hyperglycaemic effects, even in patients who are relatively unresponsive to other oral drugs”. Under the terms of the agreement, the financial terms from which have not been disclosed, Yabao receives rights to develop and commercialise the GKA in China and the partners will collaborate “to determine a strategic development plan”. The Shanxi-based group will initially perform and fund all development, with Lilly having future buy-in options for China. Peng Wang, head of R&D at Yabao, said that Lilly’s GKA has the “potential to be best-in-class”. He added that the company brings “strong clinical and regulatory capabilities” to this “ground-breaking partnership”. Yabao, founded in 1978, has 13 subsidiaries with more than 6,000 employees. It is now looking at innovative pharmaceuticals in addition to its well-established business in modern traditional Chinese medicines and generics.
http://www.pharmatimes.com/Article/14-07-07/Lilly_enters_into_China_diabetes_pact_with_Yabao.aspx#ixzz36tPIq1ic, Published 8 July 2014

Santen closes asset purchase agreement with Merck and Co. for ophthalmology assets.
Japan-based Santen Pharmaceutical has closed an asset purchase agreement which was entered on 13 May 2014 with Merck regarding the acquisition of certain ophthalmology assets, following the fulfillment of all of the transfer conditions, except in some territories, in accordance with the terms of the agreement. The completed acquisition concerns products primarily intended for Asia including Japan, South Korea and Europe excluding some countries. Santen’s payment for the closed transaction totalled about $550m and total amount of consideration for the transfer, when completed as provided for under the agreement, will reach about $600m, with additional contingency payments based on certain sales milestones and an agreement to purchase product supply from Merck. According to the company, the remaining assets will be transferred as soon as the closing conditions are fulfilled. Santen intends to disclose separately information relating to the impact that this transaction may have on the company’s forecasted fiscal performance for the fiscal year ending on 31 March 2015.
http://manufacturing.pharmaceutical-business-review.com/news/santen-closes-asset-purchase-agreement-with-merck-for-ophthalmology-assets-040714-4310965, Published 7 July 2014

Novartis leukaemia bags breakthrough status in USA.
Novartis’ leukaemia drug CTL019 has been awarded ‘breakthrough’ status in the USA, giving the personalised cell therapy a potential fast pass to market approval. The filing was submitted by the Swiss drug giant’s development partner the University of Pennsylvania’s Perelman School of Medicine (Penn), and seeks to develop the cancer immunotherapy as a treatment for paediatric and adult patients with relapsed/refractory acute lymphoblastic leukaemia (r/r ALL). There remains a high unmet need for patients with the condition, and researchers say they are “excited about the strength of the positive early data” reaped from clinical trials thus far. CTL019 uses CAR technology to reprogram a patient’s own T cells to hunt down cancer cells expressing specific proteins called CD19. Once reprogrammed, these T cells (now called CTL019) are re-introduced into the patient’s blood, where they proliferate and bind to the targeted cancer cells and destroy them. Novartis holds the worldwide rights to CARs developed through the collaboration with Penn for all cancer indications, including the lead program CTL019, which is currently being investigated in Phase II clinical trials. This is the fifth breakthrough therapy designation for Novartis.
http://www.pharmatimes.com/Article/14-07-08/Novartis_leukaemia_bags_breakthrough_status_in_USA.aspx, Published 8 July 2014

Novartis accused again of kickback tactics in new whistleblower suit.
Kickback accusations have yet again been raised against Novartis, a company that four years ago promised to live by a new integrity code. Already embroiled with the Justice Department over accusations that Novartis put together kickback schemes with pharmacies, a former exec now suggests she was fired for suggesting similar methods in the way Novartis planned to award a contract to wholesaler and health services company McKesson. The whistleblower lawsuit was filed in New Jersey by Min Amy Guo, the former executive director of Novartis’ Health Economics and Outcomes Research Group, according to the Star-Ledger. Guo claims in her lawsuit that she was fired last year after suggesting the way Novartis proposed awarding a contract to McKesson for a study of cancer drug Afinitor “it presented a conflict of interest and an appearance of kickbacks under the disguise of research.” Novartis denies Guo’s charges, telling the Star-Ledger it “is committed to the highest standards of ethical and compliant business conduct in all aspects of its business and invests significant time and resources to ensure it does business in a responsible manner.” Guo’s suit suggests otherwise. She said the project was proposed in 2012 and was going to take a month to complete, but cost $400,000, a figure she said was “too costly.” And instead of the study of breast cancer drug Afinitor going through Guo’s group as protocol for third-party studies called for, it was going to be overseen by the Oncology Scientific Operations-Managed Markets group, which Guo said is “focused on client interaction,” not on research. Guo said in her lawsuit that her position was “vindicated” when the executive director of clinical operations nixed the contract “for many of the same reasons.” But she says Novartis retaliated against her, letting her go for raising objections.
http://www.fiercepharma.com/story/novartis-accused-again-kickback-tactics-new-whistleblower-suit/2014-07-08, Published 9 July 2014

CliniWorks, Pfizer to develop population health management platform.
CliniWorks has announced a strategic alliance between its subsidiary from Israel CliniWorks (Israel) and Pfizer to jointly advance the parties’ respective capabilities in working with healthcare provider organizations to identify and close clinical or quality gaps to improve population health. The two companies are partnering to develop a population health management platform solution that leverages CliniWorks’ technologies in disparate data aggregation and Natural Language Processing (which interprets free text information) of de-identified healthcare data and Pfizer’s scientific, clinical and disease expertise. This platform will aim to enable large medical groups and integrated delivery system institutions to deliver near real-time and more efficient and effective quality healthcare, as well as improve patient engagement or activation, reaching the Centers for Medicare and Medicaid (CMS) Triple Aim. The development work will be partially supported by a grant received by CliniWorks and Pfizer from the BIRD Foundation. Nitzan Sneh, CliniWorks CEO, said, “Pfizer’s leadership position in global healthcare and patient care complements our technology capabilities and, collectively, will bring about significant efficiencies for healthcare delivery organizations involved in the continuum of patient care.” “This alliance builds on our existing relationship with CliniWorks and will allow us to collaborate with our key customers in innovative and impactful ways to potentially improve healthcare delivery and patient outcomes,” said Teresa Griesing, VP North America Medical Affairs, Pfizer Global Innovation Pharma Business Unit.
http://itsoftware.pharmaceutical-business-review.com/news/cliniworks-pfizer-to-develop-population-health-management-platform-080714-4312695, Published 8 July 2014

Roche’s lung cancer drug alectinib gets approval in Japan.
Roche has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for alectinib to treat people living with non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase fusion gene-positive (ALK+). Alectinib’s approval was based on data from a Japanese Phase I/II clinical trial (AF-001JP) for people whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable). The trial was carried out in 13 medical institutions in ALK fusion gene positive recurrent or advanced non-small cell lung cancer patients with a treatment history of one or more chemotherapy regimens. It included two phases: Phase I that assessed safety, tolerability, pharmacokinetic parameters and recommended dose (24 patients), and a Phase II part that evaluated the efficacy and safety of the recommended dose (46 patients). The company intends to make the drug available in Japan later in 2014. In June 2013, the US Food and Drug Administration (FDA) had granted breakthrough therapy designation (BTD) to alectinib for patients with ALK+ NSCLC who progressed on crizotinib. Roche chief medical officer and head of Global Product Development Sandra Horning said the approval of alectinib, a treatment specifically targeted to ALK+ lung cancer, in Japan is great news for people living with this difficult to treat disease. “Another interesting aspect of alectinib is that based on early studies it may also work in people living with tumours that have spread to the brain, a difficult area to reach with current medicines. Our research will continue in this area,” Horning said. Currently, alectinib is evaluated in global pivotal studies, which will further inform on the clinical value of the drug in this disease setting as well as in treatment-naïve patients. The company said that the results of these studies will be used in future regulatory submissions in the US and in Europe.
http://regulatoryaffairs.pharmaceutical-business-review.com/news/roches-lung-cancer-drug-alectinib-gets-approval-in-japan-070414-4311194, Published 7 July 2014

Sanofi’s marketing application for basal insulin Toujeo, gets FDA approval.
Sanofi said Tuesday that the FDA has accepted for review a filing for its experimental basal insulin Toujeo (insulin glargine), also known as U300. Pierre Chancel, senior vice president of Global Diabetes at the company, noted “we are anticipating the regulatory decision for marketing authorisation for Toujeo in the US in the first half of 2015.” According to Sanofi, the submission for Toujeo is based on results from the EDITION clinical trial programme, which is evaluating the efficacy and safety of the therapy in more than 3500 people from broad and diverse diabetes populations. The company added that in May, the European Medicines Agency accepted a marketing application for Toujeo.
http://www.firstwordpharma.com/node/1222912?tsid=28&region_id=2#axzz36tGm6jCA, Published 8 July 2014

Sanofi/Regeneron’s dupilumab succeeds for skin disorder.
Sanofi and Regeneron’s dupilumab has shown positive results in a Phase IIb study for moderate-to-severe atopic dermatitis, a serious, chronic form of eczema. The data showed that all five subcutaneous doses of dupilumab showed an improvement in the primary endpoint, the mean percent change in the Eczema Area and Severity Index (EASI) score score from baseline to week 16. These ranged from a high of 74% for patients on 300mg weekly to a low of 45% for those on 100mg monthly; this compared to 18% for all doses for patients in the placebo group. Meantime, data from two Phase IIa trials and two Phase I studies of dupilumab, which blocks the action of two proteins involved in inflammation, interleukin-4 and IL-13, were published in the New England Journal of Medicine. The data showed that the drug as monotherapy or in combination with topical glucocorticoids improved skin lesions and itching. The data, “coupled with our Phase IIa results in asthma last year, support the growing scientific evidence that the IL4/IL-13 pathway may be a fundamental driver in allergic diseases,” said George Yancopoulos, Regeneron’s chief scientific officer. He added that blocking IL-4/IL-13 signalling “may provide an important new approach to atopic conditions, including asthma, atopic dermatitis and nasal polyposis”. Elias Zerhouni, Sanofi’s R&D chief, said atopic dermatitis is known to have “a profoundly negative effect on quality of life and people with more severe forms of this disease have limited therapeutic choices”. He added that “we are now able to select the optimal doses for the phase 3 studies, which we anticipate to begin later this year”.

http://www.pharmatimes.com/Article/14-07-10/Sanofi_Regeneron_s_dupilumab_succeeds_for_skin_disorder.aspx, Published 10 July 2014

Sanofi dengue vaccine shows promise.
Detailed analysis of Sanofi’s dengue vaccine, the first to show efficacy against the fever, has excited observers even if its benefits are more moderate than had been hoped. The French giant’s Sanofi Pasteur division announced the publication in The Lancet of its first landmark Phase III dengue vaccine efficacy study conducted in five countries in Asia. Results show overall efficacy against symptomatic dengue of 56.5% in children aged two to 14 after a three-dose vaccination schedule and an 88.5% reduction of dengue haemorrhagic fever, the severest form. The study also showed a clinically important reduction in the risk of hospitalisation due to dengue by 67% during the study. Each year, some 500,000 people, including children, require hospitalisation from dengue, which caused by four virus serotypes and is a threat to nearly half of the world’s population; the World Health Organisation estimates up to 100 million infections per year. The study’s authors wrote that in view of the high disease burden in endemic countries, Sanofi’s dengue vaccine, “despite moderate overall efficacy, could have a substantial effect on public health”. Maria Rosario Capeding from the Research Institute for Tropical Medicine in the Philippines and the study’s principal investigator, noted that the vaccine’s impact on preventing dengue haemorrhagic fever is noteworthy, and a treatment “that is able to avoid the personal suffering and reduce this significant health burden would change the lives of millions”. John Shiver, R&D chief at Sanofi Pasteur, said the results “take us closer to our ambition to bring the first vaccine against dengue to the world”. He added that “after more than 20 years of commitment in collaboration with the scientific community, we are on course to make dengue the next vaccine-preventable disease”.
http://www.pharmatimes.com/Article/14-07-11/Sanofi_dengue_vaccine_shows_promise.aspx, Published 11 July 2014

Teva’s oral contraceptive Seasonique gets CHMP recommendation of approval.
Teva announced Friday that its application to market the extended-regimen oral contraceptive Seasonique (levonorgestrel/ethinyl estradiol) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP). The company said the regimen’s seven-day ethinyl estradiol intervals, rather than placebo intervals, allow women to have four periods per year and can “potentially [lessen] the withdrawal symptoms that result from a sudden, sharp decrease in hormones.” Aine Scibelli, senior director of global marketing women’s health at Teva, suggested “many women may not be aware that they can space their periods.” She added that, if approved, Seasonique would give “women a new choice in contraception to achieve greater freedom and confidence in their birth control.” Upon approval, Teva indicated that it expects to introduce the product by the end of the year, starting in Austria, Slovakia and Poland, with additional country launches to follow. The contraceptive was approved in 2006 in the US, where the drugmaker says “it gained 25 percent of the market share within two years.” A lower-dose formulation of the product was cleared there in 2008. Meanwhile, Teva said Seasonique was also approved in Chile last November and in Brazil this past April.
http://www.firstwordpharma.com/node/1222563?tsid=28&region_id=2#axzz36n8QnjQa, Published 7 July 2014

UCB, Dermira to develop and commercialize Cimzia in dermatology.
Belgium-based biopharmaceutical firm UCB has entered into an exclusive licensing agreement with Dermira, a US-based dermatology firm, to develop and future commercialize Cimzia (certolizumab pegol) in dermatology. The deal aims to broaden patient access to Cimzia and make it available to patients with psoriasis, a chronic autoimmune disorder. Currently, Cimzia is not approved for the treatment of psoriasis by any regulatory authority. UCB chief medical officer and executive vice president Iris Loew-Friedrich said the Dermira team has a track record in dermatology drug development and commercialization and the company looks forward to its collaboration. “Since the first US approval of Cimzia in 2008, we continue to evaluate its potential across severe immunological diseases with the goal of bringing this treatment option to more patients,” Loew-Friedrich said. “The exploratory Phase 2 studies in patients with plaque psoriasis have shown promising data that support further clinical development. “In addition, the improvement in psoriasis skin symptoms observed in patients with significant skin involvement in the pivotal RAPID-Psoriatic Arthritis study, were consistent with those seen in our Phase 2 study in patients with plaque psoriasis. “The RAPID study supported the approval of Cimzia in psoriatic arthritis in US and EU in 2013. With Dermira, we now have a strong specialized partner with whom to move forward to make Cimzia available to patients living with psoriasis and their physicians.” As part of the deal, UCB grants Dermira an exclusive license to develop certolizumab pegol in psoriasis in the US, Canada and the EU. Dermira will be responsible for Phase III development costs as well as will receive payments of about $49.5m on the achievement of development and regulatory milestones. Subject to regulatory approval of Cimzia in psoriasis, Dermira is granted an exclusive commercial license to market the drug to dermatologists in the US and Canada. The deal will see UCB record the sales and Dermira receive tiered royalty payments on those product sales which are attributable to dermatologists in the US and Canada and about $40m upon the achievement of tiered commercial milestones. In order to support the partnership, UCB has made a $5m equity investment in Dermira and a commitment to invest about an additional $15m in future Dermira equity financings.
http://contractservices.pharmaceutical-business-review.com/news/ucb-dermira-to-develop-and-commercialize-cimzia-in-dermatology-040714-4310942, Published 7 July 2014

Valeant Pharmaceuticals Completes Sale Of Filler And Toxin Assets To Galderma.
Valeant Pharmaceuticals International, Inc. today announced it has completed the sale to Galderma of all rights to Restylane, Perlane, Emervel, Sculptra, and Dysport owned or held by Valeant for $1.4 billion in cash, pursuant to the previously announced agreement with Nestle S.A, which recently completed its acquisition of Galderma. “We are pleased to complete the divestiture of our products to a company that is firmly committed to the aesthetic dermatology market,” said J. Michael Pearson, chairman and chief executive officer. “Humberto Antunes, CEO of Galderma, has embraced our commercial team and I know he will continue our efforts to build strong relationships with the healthcare leaders in this industry.”
http://www.firstwordpharma.com/node/1223461?tsid=28&region_id=4#axzz374oezsrv, Published 10 July 2014

NOTICIAS FARMACEUTICAS INTERNACIONALES DEL 9 DE JUNIO AL 13 DE JUNIO DEL 2014.

INDEX:

Allergan refuses Valeant’s latest revised takeover offer.
AstraZeneca signs $232 million pact with UK’s Synairgen.
Bristol-Myers Squibb loses US appeal to overturn patent invalidity ruling for Baraclude.
FDA approves Biogen haemophilia A therapy Eloctate.
FDA launches openFDA to provide easy access to valuable FDA public data.

GlaxoSmithKline to pay $105m in asthma, antidepressant drugs settlement.
GlaxoSmithKline, Theravance report positive Phase III results for COPD regimen.
Lilly’s Cyramza misses main goal in late-stage liver cancer study.
Merck & Co. expands in hepatitis C with deal to buy Idenix for $3.85 billion.
MorphoSys and Merck Serono Enter Strategic Immuno-Oncology Collaboration.
X-Chem, Pfizer to develop new treatments for inflammatory, orphan diseases.

Roche’s Herceptin tied to low incidence of cardiac events: study
Sanofi and Lilly announce licensing agreement for Cialis® (tadalafil) OTC.
Teva’s AZILECT gets FDA approval to treat all stages of Parkinson’s disease.
Valeant’s Jublia for onychomycosis gets FDA approval.

Allergan refuses Valeant’s latest revised takeover offer.
Allergan announced Tuesday that its board of directors unanimously rejected Valeant Pharmaceuticals’ latest revisedmerger proposal. The drugmaker said the offer submitted on May 30, which boosted the cash component of the bid to $72 per share, “substantially undervalues the company” and also “creates significant risks and uncertainties for the stockholders.” Last week, Valeant CEO Michael Pearson indicated the Canadian drugmaker may soon attempt a hostile takeover Allergan, while partner Pershing Square Capital Management, which is working jointly with Valeant in its takeover bid, is seeking to replace six of Allergan’s nine directors.
http://www.firstwordpharma.com/node/1216228?tsid=28&region_id=6#axzz349hIORIy, Published 10 June 2014

AstraZeneca signs $232 million pact with UK’s Synairgen.

AstraZeneca has boosted its blossoming respiratory franchise by bagging rights to Synargen of the UK’s investigational asthma drug. The treatment in question is SNG001, a novel, inhaled interferon beta in clinical development for treating respiratory tract viral infections in patients with severe asthma. Cashwise, the Southampton-headquartered company will bank $7.25 million upfront and potential development, regulatory and commercial milestones of up to $225 million. Synairgen is also eligible for tiered royalties up to mid-teens on commercial sales, while AstraZeneca will be responsible for future development costs. The latter will begin a Phase IIa study early next year. Maarten Kraan, head of respiratory, inflammation and autoimmune innovative medicines, said that respiratory is a core therapeutic area for AstraZeneca “and a key growth platform for the company”. He added that SNG001 is “an innovative and targeted therapy that has, if successful, the potential to offer a step-change in the treatment of severe asthma, and possibly chronic obstructive pulmonary disease.”

http://www.pharmatimes.com/Article/14-06-12/AstraZeneca_signs_232_million_pact_with_UK_s_Synairgen.aspx, Published 12 June 2014

Bristol-Myers Squibb loses US appeal to overturn patent invalidity ruling for Baraclude.
The US Court of Appeals for the Federal Circuit on Thursday upheld a February 2013 lower court ruling that invalidated a patent for Bristol-Myers Squibb’s hepatitis B drug Baraclude (entecavir). The company said it is “reviewing the decision and considering all its legal options.” Specifically, Teva challenged a patent held by Bristol-Myers Squibb covering the active ingredient in Baraclude, which was scheduled to expire in 2015, stating that it is invalid because of the “obviousness” of its invention. Bristol-Myers Squibb subsequently challenged the ruling by the US District Court in Delaware in a bid to keep Teva’s product off the market until the patent expires. Meanwhile, Teva stated that its generic drug application for Baraclude has received tentative FDA clearance, and that it will finalise launch plans for the product once it receives final approval.
http://www.firstwordpharma.com/node/1217153?tsid=28&region_id=2#axzz34WiogaIh, Published 13 June 2014

FDA approves Biogen haemophilia A therapy Eloctate.
Biogen Idec been boosted by approval in the USA for its haemophilia A treatment Eloctate. The Food and Drug Administration’s green light for Eloctate, (antihaemophilic factor [recombinant] Fc fusion protein) makes it the first haemophilia A treatment designed to require less frequent injections when used to prevent or reduce the frequency of bleeding. Approval of the drug, which was co-developed with partner Swedish Orphan Biovitrum (Sobi), is based on data from a trial of 164 patients which demonstrated its effectiveness and no safety concerns were identified. Biogen chief executive George Scangos said that “the proven ability of Eloctate to provide protection from bleeding episodes with prolonged circulation marks the first significant haemophilia A treatment advance in more than 20 years”. Current treatments must be infused two to three times a week, while Eloctate infusions are every three-to-five days. The inherited blood clotting disorder, which primarily affects males, is caused by defects in the Factor VIII gene and affects one in every 5,000 males born in the USA. The Eloctate thumbs-up comes on the back of Biogen and Sobi’s Alprolix (recombinant factor IX Fc fusion protein) getting the green light by the FDA in March for haemophilia B.
http://www.pharmatimes.com/Article/14-06-07/FDA_approves_Biogen_haemophilia_A_therapy_Eloctate.aspx, Published 9 June 2014
FDA launches openFDA to provide easy access to valuable FDA public data.

The U.S. Food and Drug Administration has launched openFDA, a new initiative designed to make it easier for web developers, researchers, and the public to access large, important public health datasets collected by the agency. In alignment with the recent Presidential Executive Order on Open Data and the Department of Health and Human Services Health Data Initiative, openFDA will make the FDA’s publicly available data accessible in a structured, computer readable format that will make it possible for technology specialists, such as mobile application creators, web developers, data visualization artists and researchers to quickly search, query, or pull massive amounts of public information instantaneously and directly from FDA datasets on an as needed basis. OpenFDA utilizes a search-based Application Program Interface (API) to collect large amounts of existing publicly available data, offering developers the ability to search through text within that data, ranking results much like a search using Google would do. This method then allows them to build their own applications on top of openFDA, giving them a large amount of flexibility to determine what types of data they would like to search and how they would like to present that data to end-users. This enables a wide variety of applications to be built on one common platform. “The openFDA initiative leverages new technologies and methods to unlock the tremendous public data and resources available from the FDA in a user-friendly way,” said Walter S. Harris, the FDA’s chief operating officer and acting chief information officer. “OpenFDA is a valuable resource that will help those in the private and public sectors use FDA public data to spur innovation, advance academic research, educate the public, and protect public health.” The initiative is the result of extensive research with internal officials and external developers to identify those datasets that are in recurrent demand and are traditionally fairly difficult to use. Based on this research, the FDA decided to phase in openFDA beginning with an initial pilot program involving the millions of reports of drug adverse events and medication errors that have been submitted to the FDA from 2004 to 2013. Previously, the data was only available through difficult to use reports or Freedom of Information Act requests. The adverse events data made available under this initiative do not contain any data that could potentially be used to identify individuals or other private information. The pilot will later be expanded to include the FDA’s databases on product recalls and product labeling. “Through this new and novel approach to data organization, these reports will be available in their entirety so that software developers can build tools to help signal potential safety information, derive meaningful insights, and get information to consumers and health care professionals in a timely manner,” said Taha Kass-Hout, M.D., the FDA’s chief health informatics officer. ” More information can be found at open.FDA.gov or you can email the FDA for more information at open@fda.hhs.gov.
http://www.worldpharmanews.com/fda/2803-fda-launches-openfda-to-provide-easy-access-to-valuable-fda-public-data, Published 13 June 2014

GlaxoSmithKline to pay $105m in asthma, antidepressant drugs settlement.
UK pharmaceutical firm GlaxoSmithKline (GSK) has agreed to pay $105m to settle allegations that it illegally promoted its asthma drug Advair, and anti-depressant drugs Paxil and Wellbutrin. The payment settles charges brought by 45 state attorneys general, while California’s portion of the settlement is around $7.1m. The settlement prohibits the UK drug-maker from providing incentive payments to its salespeople that encourages the use of drugs not indicated on their labels, and from using paid doctors to promote its products. California attorney-general Kamala Harris said: “Patient care is undermined when pharmaceutical companies promote uses for drugs that have not been approved by the FDA or pay medical professionals to promote certain drugs. This settlement requires GSK to pay a significant penalty and imposes strong new rules designed to prevent future misrepresentations of GSK products.” The complaint and stipulated judgment that is submitted to the San Diego County Superior Court alleges that GSK violated state consumer protection laws by misrepresenting the uses and qualities of certain drugs. Under the settlement, the company is also required to continue its Patient First programme at least through March 2019, reducing financial incentives for sales representatives who engage in deceptive marketing. The settlement also needs scientifically trained personnel to be ultimately responsible for developing and approving responses to health care provider questions and for these responses to be unbiased and non-promotional.
http://manufacturing.pharmaceutical-business-review.com/news/glaxosmithkline-to-pay-105m-in-asthma-antidepressant-drugs-settlement-060614-4287587, Published 9 June 2014

GlaxoSmithKline, Theravance report positive Phase III results for COPD regimen.

GlaxoSmithKline and Theravance on Wednesday said data from two Phase III studies demonstrated that adding the anticholinergic Incruse Ellipta (umeclidinium) to Breo Ellipta (fluticasone furoate/vilanterol) significantly improved lung function in patients with chronic obstructive pulmonary disease (COPD), compared with Breo Ellipta plus placebo. Darrell Baker, head of GlaxoSmithKline’s global respiratory franchise, said the results “are an important addition to the evidence base supporting the efficacy and safety of Incruse,” adding that “these studies are also the first to investigate the combined effect of two of the newest medicines from our respiratory portfolio.” The trials involved 1238 patients with an established clinical history of COPD and a forced expiratory volume in one second (FEV1) of 70 percent or less. Patients were randomised to once-daily treatments with either one of two doses of Incruse Ellipta plus Breo Ellipta, or Breo Ellipta plus placebo. In both 12-week studies, the combination treatments were associated with significant improvements in the primary endpoint of trough FEV1 at day 85, versus Breo Ellipta alone. The drugmaker indicated that full study results would be presented at a future scientific meeting. Incruse Ellipta was recently cleared by regulatory authorities in the US, Canada andEurope for the treatment of COPD. The FDA approved Breo Ellipta for COPD in May 2013, while the therapy was later granted approval by European regulators for the same indication under the name Relvar Ellipta. The product is also marketed in Japan under the Relvar Ellipta brand as a treatment for bronchial asthma, while GlaxoSmithKline and Theravance withdrew their Japanese application for the medicine in the COPD indication last July.

http://www.firstwordpharma.com/nod de/1216709?tsid=28&region_id=6#axzz34L8JqDkO, Published 12 June 2014

Lilly’s Cyramza misses main goal in late-stage liver cancer study.
Eli Lilly announced top-line results Wednesday demonstrating that Cyramza (ramucirumab) failed to significantly improve overall survival compared with placebo in a Phase III trial involving patients with hepatocellular carcinoma. Richard Gaynor, senior vice president of product development and medical affairs at Eli Lilly’s oncology division, commented that while the REACH study did not “achieve statistical significance for survival, we are encouraged by the efficacy seen overall, especially in specific subpopulations.” He added that the company “[plans] to discuss these results with regulatory authorities.” In April, the drug gained US approval for patients with unresectable or metastatic gastric cancer or gastroesophageal junction adenocarcinoma angiogenesis after being treated with a fluoropyrimidine- or platinum-containing therapy.
http://www.firstwordpharma.com/node/1216586?tsid=28&region_id=6#axzz34L8JqDkO, Published 11 June 2014

Merck & Co. expands in hepatitis C with deal to buy Idenix for $3.85 billion.
Merck & Co. announced Monday a definitive agreement to acquire Idenix Pharmaceuticals for $24.50 per share in cash, or approximately $3.85 billion, boosting its pipeline of hepatitis C drugs. The companies noted that the transaction, which represents a premium of more than triple Idenix’s closing share price on June 6, has been approved by both boards of directors and is expected to close in the third quarter. Roger Perlmutter, president of Merck Research Laboratories, remarked “Idenix has established a promising portfolio of hepatitis C candidates,” adding that the compounds “complement our promising therapies in development and will help advance our work to develop a highly effective, once-daily, all oral, ribavirin-free, pan-genotypic regimen.” Perlmutter suggested that “the future” in HCV treatment lies in triple drug combinations, commenting “we’re looking to bring this to patients around the world to ultimately cure hepatitis C virus infection in everyone.” Merck noted that Idenix currently has three HCV drug candidates in clinical development, including the two nucleotide prodrugs IDX21437 and IDX21459, along with the NS5A inhibitor samatasvir. Meanwhile, Merck is developing the NS3/4A protease inhibitor MK-5172 and the NS5A replication complex inhibitor MK-8742. In April, the company announced the initiation of Phase III studies for the combination of MK-5172 and MK-8742, which has received FDA breakthrough therapy status, with and without ribavirin in various genotypes and across a broad range of patient populations with chronic HCV. In June last year, Idenix said that clinical trials of its experimental HCV drug IDX20963 would be delayed after the FDA requested further preclinical safety information on the experimental uridine nucleotide prodrug. Earlier in 2013, the drugmakerterminated development of the nucleotide polymerase inhibitors IDX184 and IDX19368 for HCV after the FDA placed the programmes on clinical hold.
http://www.firstwordpharma.com/node/1215861?tsid=28#axzz349hIORIy, Published 9 June 2014

MorphoSys and Merck Serono Enter Strategic Immuno-Oncology Collaboration.

Co-development and license agreement that complements and further expands Merck Serono’s immuno-oncology portfolio MorphoSys’ Ylanthia next-generation antibody technology to be leveraged for the rapid identification of inhibitors against immune checkpoints MorphoSys AG (FSE: MOR; Prime Standard Segment, TecDAX, OTC: MPSYY) and Merck today announced that they have signed an agreement to discover and develop therapeutic antibodies against undisclosed immune checkpoints. Under the terms of the agreement, MorphoSys and Merck Serono, the biopharmaceutical division of Merck, will join forces to develop therapies that modulate the immune system’s natural ability to fight tumors. MorphoSys, a leader in fully human antibody technologies, will apply its proprietary Ylanthia® antibody phage library and technology platform to identify antibodies against the targets of interest. Merck Serono with its strong portfolio and capabilities in the field of immuno-oncology and clinical development will be fully responsible for execution of development from Phase 1 onwards. “The establishment of partnerships with companies with innovative technology platforms is an integral part of Merck Serono’s strategy to further expand upon our already diverse immuno-oncology portfolio,” said Dr. Helen Sabzevari, Senior VP of Immuno-Oncology at Merck Serono. “Combining Merck Serono’s extensive expertise in immuno-oncology with MorphoSys’s next-generation antibody technology provides us with an exciting opportunity to rapidly generate novel therapies with a clear potential to benefit cancer patients.” “Therapeutic agents in the immuno-oncology field are set to transform cancer therapy, and we are delighted to work with Merck Serono in this area”, commented Dr. Simon Moroney, Chief Executive Officer of MorphoSys. “We believe that our Ylanthia technology has the potential to provide truly differentiated antibodies against the targets that will be the subject of the collaboration. Merck Serono’s expertise in immuno-oncology, together with their strength in developing and commercializing therapeutic antibodies make them an ideal partner for MorphoSys.” With this partnership, Merck Serono, is committed to strengthen its existing portfolio of cancer immunotherapies that work as monotherapies or in combination with other therapeutic modalities. Under the terms of the co-development and license agreement, MorphoSys will co-fund research & development costs with the option to opt-out at predefined stages. MorphoSys will be eligible to receive development and commercial milestone payments, and in addition, tiered royalties on product sales that will reflect the extent of MorphoSys co-funding. Merck Serono will have sole responsibility for commercializing of any resulting products. Further financial details are not being disclosed.

http://www.firstwordpharma.com/node/1216882?tsid=28&region_id=3#axzz34L8JqDkO, Published 12 June 2014

X-Chem, Pfizer to develop new treatments for inflammatory, orphan diseases.
X-Chem, a privately held biotechnology company applying its cutting-edge lead discovery capabilities to the generation of novel small molecule therapeutics, has announced a multi-target collaboration with Pfizer. The collaboration is focused on the potential development of several programs for the treatment of inflammatory and orphan diseases. Under the terms of the agreement, X-Chem is applying its discovery engine, which leverages a high diversity, proprietary DNA-encoded small molecule library to seek the identification of novel leads for the Pfizer programs. Pfizer has an exclusive option to license any compounds generated in the course of the collaboration. The financial terms of the agreement were not disclosed. “The use of ultra-large and highly diverse DNA-encoded small molecule libraries has emerged as a novel technology with potential to generate leads for difficult targets of high importance,” said Tony Wood, Senior Vice President, Worldwide Medicinal Chemistry, Pfizer. “At Pfizer we are keen to explore new technologies that may help expand our pipeline of innovative medicines and are pleased to initiate this collaboration with X-Chem to access their innovative lead generation approach.” “With the ongoing expansion of X-Chem’s library, informatics capabilities, and screening expertise, we continue to identify lead molecules to challenging, high value therapeutic targets,” said Rick Wagner, Ph.D., Chief Executive Officer of X-Chem. “Our vision is to enable breakthroughs in the treatment of diseases with high unmet medical need by partnering our lead discovery engine with leaders in the pharmaceutical industry such as Pfizer.” “Through a series of strategic research collaborations, and repeated success at reaching collaboration goals and licensing programs to our partners, X-Chem has demonstrated its ability to structure and execute partnerships that bring significant value to both parties,” said Diala Ezzeddine, Ph.D., Chief Business Officer of X-Chem.
http://contractservices.pharmaceutical-business-review.com/news/x-chem-pfizer-to-develop-new-treatments-for-inflammatory-orphan-diseases-120614-4291630, Published 13 June 2014

Roche’s Herceptin tied to low incidence of cardiac events: study
Results from a long-term study published in the Journal of Clinical Oncology confirmed that a low incidence of cardiac events is associated with Roche’s breast cancer drug Herceptin (trastuzumab) when given sequentially after chemotherapy and radiotherapy. Researchers noted that the “cardiac events were reversible in the vast majority of patients,” with study author Brian Leyland-Jones saying “the overall message here is one of tremendous reassurance.” In the randomised HERA study, investigators evaluated cardiovascular outcomes in 5102 women with early-stage, HER2-positive breast cancer who either did not receive the drug, or were given adjuvant Herceptin therapy for one or two years. Eligible patients, who were followed for a median of eight years, displayed a left ventricular ejection fraction (LVEF) of at least 55 percent following neoadjuvant chemotherapy with or without radiotherapy. The researchers found that adverse cardiac events requiring Herceptin discontinuation occurred in 9.4 percent of patients in the two-year arm and in 5.2 percent of patients in the one-year arm. Further, the incidence of severe congestive heart failure was 0.8 percent in both the one- and two-year groups, compared with no cases in the observation group, while the number of cardiac deaths recorded in the two-year, one-year and observation arms was three, zero and two, respectively. “What this confirms is a very low incidence of cardiac events, even when you give two years of the drug, which is no longer practiced,” commented Leyland-Jones. Meanwhile, researchers said rates of significant decreases in LVEF were 7.2 percent and 4.1 percent in the two- and one-year arms, respectively, versus 0.9 percent in the observation arm. However, 87.5 percent of patients in the two-year group and 81.2 percent of those in the one-year group achieved acute recovery after treatment discontinuation. The authors speculated that since HER2 is linked with the regulation of cell growth and survival in the heart, using Herceptin may possibly diminish those protective effects.
http://www.firstwordpharma.com/node/1216320?tsid=28&region_id=2#axzz34L8JqDkO, Published 11 June 2014

Sanofi and Lilly announce licensing agreement for Cialis® (tadalafil) OTC.
Sanofi and Eli Lilly and Company have announced an agreement to pursue regulatory approval of nonprescription Cialis (tadalafil). Cialis is currently available by prescription only worldwide for the treatment of men with erectile dysfunction (ED). Under the terms of the agreement, Sanofi acquires the exclusive rights to apply for approval of Cialis OTC in the United States, Europe, Canada and Australia. Sanofi also holds exclusive rights to market Cialis OTC following Sanofi’s receipt of all necessary regulatory approvals. If approved, Sanofi anticipates providing Cialis OTC after expiration of certain patents. Terms of the licensing agreement were not disclosed. “This agreement provides us with an opportunity to work with Lilly, a leader in men’s health, to transform how this important medicine is offered to millions of men throughout the world,” said Vincent Warnery, senior vice president, Global Consumer Healthcare Division, Sanofi. “The opportunity to forge an industry-leading partnership that adds to Sanofi Consumer Healthcare’s leading portfolio and successful track record of over-the-counter switches reinforces consumer health care as a major growth platform for Sanofi.” “Millions of men worldwide trust Cialis to treat ED. We are pleased to work with Sanofi to pursue a path that could allow more men who suffer from ED to obtain convenient access to a safe and reliable product without a prescription,” said David Ricks, senior vice president, Lilly, and president, Lilly Bio-Medicines. “Switching a medicine to over-the-counter is a highly regulated process that is data-driven and scientifically rigorous. Together with Sanofi, we look forward to working closely with regulatory authorities to define the proper actions and necessary precautions to help patients use over-the-counter Cialis appropriately.” Cialis was first approved by the European Medicines Agency in 2002, then by the U.S. Food and Drug Administration in 2003, for the treatment of erectile dysfunction. Ultimately, Cialis has received approval in more than 120 countries for indications that vary by country, including erectile dysfunction and erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (BPH). Cialis reached $2.16 billion USD (€1.58 billion) in worldwide sales in 2013 and has recorded total global sales of more than $14 billion USD (€10.2 billion) since launch. To date, more than 45 million men worldwide have been treated with Cialis.
http://www.worldpharmanews.com/sanofi/2797-sanofi-and-lilly-announce-licensing-agreement-for-cialisr-tadalafil-otc, Published 10 June 2014

Teva’s AZILECT gets FDA approval to treat all stages of Parkinson’s disease.
Teva Pharmaceutical Industries has announced the US Food and Drug Administration (FDA) has expanded the indication for AZILECT (rasagiline tablets) from monotherapy and adjunct to levodopa (LD) to now include adjunct to dopamine agonists (DAs). The new indication reflects that AZILECT can be used alone or in combination with other Parkinson’s disease (PD) medications. The approval reinforces the growing clinical evidence demonstrating the benefit of AZILECT across all stages of PD. “The FDA approval of the expanded label for AZILECT® will be a welcome addition in the treatment of PD,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva Pharmaceutical Industries Ltd. “Teva continues its commitment to those living with PD and to research in areas of neurodegenerative diseases to develop solutions for patients with unmet needs.” The FDA approval of the expanded label is based on a supplemental new drug application (sNDA) submitted by Teva, supported by data from the ANDANTE study (Add oN to Dopamine AgoNists in the TrEatment of Parkinson’s disease). The study demonstrated AZILECT provides a clinical benefit by significantly improving total Unified Parkinson’s Disease Rating Scale (UPDRS) scores compared to placebo in patients on DA monotherapy, while demonstrating tolerability. “AZILECT has been well studied and has been shown to be safe and effective as monotherapy in early PD and as an adjunct to LD in moderate-to-advanced PD. The ANDANTE study provides evidence that AZILECT is also effective as an adjunct to dopamine agonist therapy,” said Robert A. Hauser, M.D., MBA, Professor of Neurology, Molecular Pharmacology, and Physiology at the University of South Florida. “The expanded AZILECT indication supports the concept of adding AZILECT to DA monotherapy to improve symptoms while offering another treatment option prior to either increasing the dose of DA monotherapy or initiating LD.”
http://regulatoryaffairs.pharmaceutical-business-review.com/news/tevas-azilect-gets-fda-approval-to-treat-all-stages-of-parkinsons-disease-100614-4289261, Published 10 June 2014

Valeant’s Jublia for onychomycosis gets FDA approval.
Valeant Pharmaceuticals said Monday that the FDA approved Jublia (efinaconazole), making the drug the first topical triazole approved for the treatment of onychomycosis of the toenails. CEO Michael Pearson noted “we are working quickly to get this important product launched in the US…in the third quarter,” adding that the therapy is expected to generate “peak sales of $300-$800 million in the US alone.” Valeant noted that Jublia was gained via the acquisition of Dow Pharmaceutical Sciences in 2008.
http://www.firstwordpharma.com/node/1215846?tsid=28&region_id=3#axzz349hIORIy, Published 9 June 2014

NOTICIAS FARMACEUTICAS INTERNACIONALES DEL 19 DE MAYO AL 23 DE MAYO

INDEX:

Abbott enhances its position in fast-growing Latin American market.
AstraZeneca rejects Pfizer’s improved final bid.
BI’s Nintedanib impresses.
Europe approves J&J hepatitis C drug Olysio.
FDA rejects Novartis heart failure drug Serelaxin.
FDA grants Breakthrough status for B-MS/AbbVie myeloma drug.
More criticism for Gilead over Sovaldi price.
GSK/Genmab’s Arzerra fails in Ph III lymphoma trial.

GlaxoSmithKline accused of failing to pay tax in China: report.
Novartis acquires non-US rights to Ophthotech’s experimental wet AMD drug Fovista.
Novartis’ COPD inhaler hits targets in QUANTIFY trial.
Pfizer seeks FDA approval for breast cancer drug palbociclib.
Roche unveils more plans for plant expansions in Switzerland.
Roche confirms visit by Chinese authorities.
Takeda, ASKA sign distribution deal for hypertension drug Candesartan ASKA.
Takeda’s Entyvio gets FDA approval to treat ulcerative colitis, Crohn’s disease.
Teva/Active Biotech MS pill rejected again by CHMP.
Valeant says new bid for Allergan will not be an all-cash offer.

Abbott enhances its position in fast-growing Latin American market.
Abbott has announced a definitive agreement to acquire Latin American pharmaceutical company CFR Pharmaceuticals, more than doubling its Latin American branded generics pharmaceutical presence and further expanding Abbott’s presence in fast-growing markets. Under the terms of the agreement, Abbott will acquire the holding company that indirectly owns approximately 73 percent of CFR Pharmaceuticals and will conduct a public cash tender offer for all of the outstanding shares of CFR. Assuming all publicly-held shares are tendered, the total purchase price would be approximately $2.9 billion, plus the assumption of net debt of approximately $430 million. This acquisition immediately establishes Abbott among the top 10 pharmaceutical companies in Latin America, further broadening Abbott’s geographic presence across the region. “With its scale and leadership positions in the region, strong commercial and development organizations, well-respected leadership team and a trusted portfolio of recognized brands, CFR is one of the leading branded generic companies in Latin America,” said Miles D. White, chairman and chief executive officer, Abbott. “This acquisition will significantly enhance and broaden Abbott’s Latin American footprint, and is well aligned with our long-term strategy and commitment to fast-growing markets.” Abbott expects the acquisition to add approximately $900 million to its sales in the first full year (2015), with expected double-digit sales growth over the next several years. CFR Pharmaceuticals, headquartered in Santiago, Chile, participates in 15 Latin American markets and has a comprehensive product portfolio that is well aligned with Abbott’s current pharmaceutical therapeutic areas of focus in women’s health, central nervous system, cardiovascular and respiratory diseases. The addition of CFR’s business will significantly improve Abbott’s position in several markets, and provide the opportunity to expand each company’s portfolio across Latin America. “We are pleased to join with Abbott to enhance CFR’s leadership across Latin America,” said Alejandro Weinstein, chief executive officer, CFR Pharmaceuticals. “CFR and its employees will become part of an organization much like itself, a well-respected company with a long heritage and commitment to delivering quality health care products that improve people’s lives.” CFR currently markets more than 1,000 products and has a proven track record of rapidly developing and bringing new products to market. In addition to leading products and a robust pipeline, the acquisition adds approximately 7,000 employees, and R&D and manufacturing facilities in Chile, Colombia, Peru and Argentina. The Latin American pharmaceutical market is expected to reach $73 billion in sales this year, and is expected to reach $124 billion by 2018, with estimated annual growth rates of two to three times that of developed markets over the coming years, according to IMS forecasts.
http://www.worldpharmanews.com/abbott/2777-abbott-enhances-its-position-in-fast-growing-latin-american-market, Published 21 May 2014

AstraZeneca rejects Pfizer’s improved final bid.
Pfizer’s sweetened bid to acquire AstraZeneca for £55, up from £50 per share, has been rejected. The new offer, suggested over the weekend, values the Anglo-Swedish drugmaker at £69.3 billion and increases the cash element to 45% from 32%, with the rest payable in Pfizer shares. The US major stressed that the “improved proposal is final and cannot be increased” and it will not make a hostile offer directly to shareholders. The company “will only proceed with an offer with the recommendation of the AstraZeneca board”. The figure of £55 has been mentioned in many circles as the level whereby a deal could move forward. Pfizer had offered £3.50 more per share on May 16 but said that during discussions earlier on Sunday, “AstraZeneca made clear that it is not currently prepared to accept a price close to Pfizer’s £53.50 proposal”. The UK drug giant has held steadfast and has rejected the improved bid, with AstraZeneca chairman Leif Johansson saying “the Final Proposal is a minor improvement that continues to fall short of the Board’s view of value and has been rejected”. He said Pfizer’s bids had been “fundamentally driven by the corporate financial benefits to its shareholders of cost savings and tax minimisation”, adding that “Pfizer has failed to make a compelling strategic, business or value case.” “We have rejected Pfizer’s Final Proposal because it is inadequate and would present significant risks for shareholders, while also having serious consequences for the Company, our employees and the life-sciences sector in the UK, Sweden and the US.” Chief executive Ian Read said “we have tried repeatedly to engage in a constructive process [but] we do not believe that the AstraZeneca board is currently prepared to recommend a deal at a reasonable price”. He added that “we remain ready to engage in a meaningful dialogue but time for constructive engagement is running out”, claiming that “other issues that have been raised by AstraZeneca do not represent material difficulties”. Ana Nicholls, healthcare analyst at the EIU, said: “A Pfizer-AZ deal now looks unlikely, bar a rebellion by AZ shareholders. Pfizer’s ‘final’ offer was so much better than its previous one – not just because it raised the price but also because it raised the amount it was prepared to pay in cash – that its own shareholders may well object to it coming back with an even higher bid. AZ has commented on the lack of commercial logic for the deal, beyond the tax and financial savings, but the unpopularity of the deal among UK politicians and media probably also played a role. There may also be a general concern in the industry that mega-mergers destroy rather than create value for shareholders.” According to AstraZeneca, any new bid would need to be more than 10% above the £53.50 proposal for the board to be able to recommend it. However, in early trading, AstraZeneca’s shares dropped 13% on the back of the rejected bid, plunging to its lowest in almost 12 years. Under British takeover rules, Pfizer now has to wait six months before it can present a new bid.
http://www.pharmatimes.com/Article/14-05-19/UPDATED_AstraZeneca_rejects_Pfizer_s_improved_final_bid.aspx, Published 19 May 2014

BI’s Nintedanib impresses.
As an eagerly-anticipated debate kicks off at the American Thoracic Society conference in San Diego on drugs for idiopathic pulmonary fibrosis, Boehringer Ingelheim has posted promising late-stage data on its offering, nintedanib. The company has published data from the two Phase III INPULSIS trials involving 1,066 patients, showing that nintedanib met its primary endpoint of slowing disease progression. Specifically, the drug significantly reduced the annual decline in forced vital capacity (FVC) by some 50% compared to patients taking placebo over 52 weeks. Both key secondary endpoints were met in the INPULSIS-2 trial, namely significantly less deterioration in quality of life and a reduced risk of a first acute exacerbation in patients taking nintedanib, compared to placebo. Study investigator Luca Richeldi of the University of Southampton said the latter is of particular clinical importance, because unlike with chronic obstructive pulmonary disease, “acute exacerbations are rapid and unexplained episodes of deterioration in IPF [which] can lead to death in approximately half of the patients.” In INPULSIS-1, however, there was no statistically significant difference between the nintedanib and placebo groups in the key secondary endpoints. Prof Richeldi told PharmaTimes here in San Diego that he is very impressed by the data “as most trials before this were negative or showed increased mortality in the treatment arm”. He added that “for the very first time we see two massive trials providing exactly the same results over one year”, highlighting the global reach of the studies (including India, China, Europe and North and South America) and the fact that the results were “remarkably similar” to those seen in Phase II. Charles de Wet, Boehringer’s UK medical director, said “we are delighted that these latest Phase III results show benefits for patients with this devastating disease”, adding that “we have a long heritage in the respiratory arena”. The nintedanib data will be presented during the New England Journal of Medicine and the Journal of the American Medical Association here at the ATS (10pm UK time). The meeting room will be packed for the session as data from InterMune’s ASCEND study on its IPF drug Esbriet (pirfenidone) will also be presented and there will be a discussion on the merits of the two treatments (analysis on PharmaTimes to follow).
http://www.pharmatimes.com/Article/14-05-18/In_battle_of_IPF_drugs_BI_s_nintedanib_impresses.aspx, Published 19 May 2014

Europe approves J&J hepatitis C drug Olysio.
Johnson & Johnson and partner Medivir are celebrating after getting European approval for their hepatitis C drug Olysio. Specifically, Olysio (simeprevir) has been granted marketing authorisation by the European Commission for the treatment of genotype 1 and 4 HCV. The most significant element of the approval is that the drug will be available as part of the very first 12 week, all-oral, once-daily, interferon-free combination along with Gilead Sciences’ huge-selling Sovaldi (sofosbuvir). J&J’s Janssen unit noted that Olysio, an NS3/4A protease inhibitor, will be available across a number of European Union countries, depending on reimbursement, in the second half of 2014. It was approved in the USA in November but not for use with Sovaldi, although a filing for that combo was submitted to the Food and Drug Administration earlier this month.Thomas Stark, medical director for Janssen EMEA said the approval is “a great milestone as it adds an important new treatment option for patients, demonstrating the continued role of triple therapy [for HCV”.
http://www.pharmatimes.com/Article/14-05-17/Europe_approves_J_J_hepatitis_C_drug_Olysio.aspx, Published 14 May 2014

FDA rejects Novartis heart failure drug Serelaxin.
As expected, regulators in the USA have rejected Novartis heart failure drug serelaxin, a treatment that has breakthrough therapy designation. The US Food and Drug Administration has issued a complete response letter regarding the Biologics License Application for serelaxin for the treatment of acute heart failure, stating that further evidence on its efficacy is required. The rejection comes a couple of months after the agency’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously against approval. The submission for the drug, which is a relaxin receptor agonist, included one Phase III trial, the design of which was criticised by FDA staffers. Now Novartis is conducting a second late-stage trial which will enroll over 6,300 patients to expand the data, though this is unlikely to report for a couple of years. Nevertheless, Novartis remains upbeat about the prospects for serelaxin and Tim Wright, head of pharmaceutical development, said “we continue to believe [it] has the potential to be an important treatment for AHF”. He added that Novartis has been “encouraged by feedback from FDA advisory committee members noting the data are intriguing”.
http://www.pharmatimes.com/Article/14-05-17/FDA_rejects_Novartis_heart_failure_drug_serelaxin.aspx, Published 19 May 2014
FDA grants Breakthrough status for B-MS/AbbVie myeloma drug.

The US Food and Drug Administration has granted breakthrough therapy designation to Bristol-Myers Squibb and AbbVie’s elotuzumab for multiple myeloma. The status has been granted specifically for use of elotuzumab in combination with lenalidomide and dexamethasone for MM patients who have received one or more prior therapies. The designation is based on a Phase II study presented at last year’s European Haematology Association meeting which showed that the triple combo offered a signifiant benefit in progression-free survival (33 months). Breakthrough designation differs from the FDA’s other fast-track programmes as it involves more intensive guidance from the agency on putting together an efficient drug development programme. The criteria require preliminary clinical evidence that demonstrates the drug may have substantial improvement on at least one clinically significant endpoint over available therapy. Michael Giordano, head of oncology and immunosciences development at B-MS, said that “despite recent advances in the treatment of relapsed or refractory MM, it remains an area of unmet need”. He added that getting breakthrough status “underscores the potential of elotuzumab in this setting”.

http://www.pharmatimes.com/Article/14-05-19/Breakthrough_status_for_B-MS_AbbVie_myeloma_drug.aspx, Published 20 May 2014

More criticism for Gilead over Sovaldi price.
The price of Gilead Sciences’ game-changing hepatitis C drug is back in the spotlight following comments from a leading insurance trade group in the USA adding its voice to claims that $1,000 per pill is unsustainable. An American Health Insurance Plans blog has reignited the debate on Sovaldi (sofosbuvir), noting that although the drug “has shown tremendous results, and it’s the kind of medical innovation we need to sustain…unfortunately, the drug’s maker – taking advantage of a lack of competition – has priced it at an astronomical level that is not sustainable for consumers, innovation, or society”. The AHIP notes that a 12-week course of Sovaldi costs $84,000, and “it’s typically prescribed along with other medicines and courses of treatments that can boost the cost to $150,000”. The blog goes on to claim that “Sovaldi is only the beginning”, as “more and more specialty drugs and other high cost prescriptions are coming into the marketplace that hold tremendous potential for patients, but are being priced in a way that threatens Americans’ access to them”. Gilead has been the target of much criticism since the hugely-successful launch in December of Sovaldi, heightened by its first-quarter sales of $2.27 billion. The company has continually defended the price on the grounds that the drug cuts total treatment costs for HCV and provides a cure.
http://www.pharmatimes.com/Article/14-05-22/More_criticism_for_Gilead_over_Sovaldi_price.aspx, Published 22 May 2014

GSK/Genmab’s Arzerra fails in Ph III lymphoma trial.

GlaxoSmithKline/Genmab’s leukaemia drug ofatumumab (marketed as Arzerra) has hit a setback after failing to meet targets in a late-stage trial assessing its potential in patients with B-cell lymphoma. GSK said it is now unlikely that ofatumumab will be filed for this indication, given that a combination of the drug plus chemotherapy failed to outperform a rituxan/chemotherapy combo on progression free survival in patients with relapsed/refractory diffuse large B-cell lymphoma, the most common form of non-Hodgkin lymphoma (NHL). Also, while the 447-patient Phase III trial showed no differences between the two treatment groups in adverse events leading to treatment discontinuation, or severe or fatal ones, there were more dose interruptions and delays due to infusion reactions and increased serum creatinine in the ofatumumab arm “which require further analysis,” the firm added.“We are disappointed that the ORCHARRD study did not meet its primary endpoint,” Rafael Amado, Head of Oncology R&D, GSK, said in a statement, adding that more detailed data from the study will be presented at a medical conference later this year, “which we hope will provide further clarity” on the headline results. Arzerra is a monoclonal antibody that causes the body’s immune response to fight against normal and cancerous B-cells. The drug was first given a green light by the US FDA in 2009 for the treatment of patients with chronic lymphocytic leukaemia (CLL) who have not responded to Genzyme’s Campath (alemtuzumab) or the chemotherapy fludarabine, and more recently for patients who have not received prior therapy and for whom fludarabine-based therapy is considered inappropriate.

http://www.pharmatimes.com/Article/14-05-20/GSK_Genmab_s_Arzerra_fails_in_Ph_III_lymphoma_trial.aspx, Published 20 May 2014

GlaxoSmithKline accused of failing to pay tax in China: report.
According to Chinese state-run newspaper The Legal Daily, GlaxoSmithKline failed to pay more than 100 million yuan ($16 million) in taxes between 2005 and 2008. Specifically, the newspaper alleged that by importing the HIV and hepatitis therapy Epivir (lamivudine) at an elevated cost and using tax loopholes, the drugmaker avoided “over 100 million yuan in import value-added tax and corporate income tax.” The report also said that GlaxoSmithKline evaded taxes by donating supplies of the imported drug to support state-backed treatment of hepatitis, adding that the company could have donated a less expensive drug that was produced at a domestic facility. “The most serious thing is that through this sham charity, [GlaxoSmithKline] blocked the Chinese government making its own generic drugs to treat AIDS, so that it could attain a monopoly over the hepatitis drug market,” the report said. According to legal sources as well as a person with direct knowledge of the GlaxoSmithKline investigation, Chinese officials may consider filing charges against the company itself. The drugmaker did not respond to request for comments on the news. The report follows the recent indictment of Mark Reilly, former head of GlaxoSmithKline’s who has been accused of ordering his sales team and other employees to bribe hospital doctors, healthcare organisations and other parties to boost drug sales. Such announcement followed a probe of the drugmaker, which was initiated last year.
http://www.firstwordpharma.com/node/1211144?tsid=28&region_id=6#axzz32CDWXHLI, Published 21 May 2014

Novartis acquires non-US rights to Ophthotech’s experimental wet AMD drug Fovista.

Novartis and Ophthotech announced Monday an agreement giving the former exclusive rights to commercialise the experimental wet age-related macular degeneration (AMD) therapy Fovista (anti-PDGF aptamer) outside the US for $200 million up front and other milestone payments. Ophthotech, which estimated that the agreement could be potentially worth more than $1 billion, will retain US rights to the drug. David Epstein, head of pharmaceuticals at Novartis, said “if approved, Fovista is expected to be the first to market in this class of therapies for wet AMD confirming our commitment and leadership in the ophthalmology space.” Under the terms of the agreement, Novartis said it will pay Ophthotech up to $130 million in milestones related to enrolment in an ongoing Phase III programme for Fovista, which is expected to have interim, topline data available in 2016. Ophthotech is also eligible to receive non-US approval milestones of as much as $300 million and sales milestones outside the US of up to $400 million. In addition, as part of the collaboration, the companies will develop a co-formulation of Fovista with a Novartis proprietary anti-VEGF treatment. “The collaboration not only provides a substantial strategic and financial benefit to Ophthotech, it also begins to put in place essential elements designed to expand the reach of Fovista outside the United States, following potential regulatory approvals,” remarked Ophthotech CEO David R. Guyer. Shares in the company rose nearly 24 percent on the news.

http://www.firstwordpharma.com/node/1211261?tsid=28&region_id=2#axzz32CDWXHLI, Published 20 May 2014

Novartis’ COPD inhaler hits targets in QUANTIFY trial.
Novartis has announced positive data from a late-stage trial pitting its COPD inhaler Ultibro Breezhaler (indacaterol/glycopyrronium) against combination therapy with tiotropium and formoterol. The Swiss drug giant said the study meet its primary endpoint of showing non-inferiority of Ultibro Breezhaler compared to tiotropium 18mcg/formoterol 12mcg in improving health-related quality of life outcomes in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). Also in the study, which included over 900 COPD patients, once-daily Ultibro Breezhaler induced superior improvements in lung function at 26 weeks compared to once-daily tiotropium plus twice-daily formoterol, while patients taking Novartis’ inhaler were also more likely to demonstrate a clinically meaningful improvement in shortness of breath and health-related quality of life, the firm said. Tim Wright, Global Head of Development at Novartis Pharmaceuticals, noted that the results “demonstrate that once-daily Ultibro Breezhaler can provide better symptom control versus a combination of two individual treatments, tiotropium plus formoterol”. Ultibro Breezhaler is a novel, once-daily dual bronchodilator approved as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD, which is predicted to become the third leading cause of death by 2020.

http://www.pharmatimes.com/Article/14-05-22/Novartis_COPD_inhaler_hits_targets_in_QUANTIFY_trial.aspx, Published 22 May 2014

Pfizer seeks FDA approval for breast cancer drug palbociclib.
US-based drug maker Pfizer is planning to submit a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for palbociclib, combined with letrozole, as first-line systemic treatment of post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer. The submission is expected to take place in the third quarter of 2014 based on discussions with the FDA regarding the final results of PALOMA-1, a randomized, Phase II trial comparing palbociclib plus letrozole versus letrozole alone in these patients. In April 2013, the investigational oral targeted agent palbociclib received FDA Breakthrough Therapy designation for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. The FDA breakthrough therapy status was based on interim data from the PALOMA-1 trial. The company said that palbociclib selectively inhibits cyclin-dependent kinases (CDKs) 4 and 6 to regain cell cycle control and block tumor cell proliferation. Loss of cell cycle control is a hallmark of cancer and CDK 4/6 are overactivated in several cancers, leading to loss of proliferative control. The trial is designed to evaluate progression-free survival in post-menopausal women with ER+, HER2- advanced breast cancer receiving palbociclib.
http://regulatoryaffairs.pharmaceutical-business-review.com/news/pfizer-seeks-fda-approval-for-breast-cancer-drug-palbociclib-190514-4271140, Published 19 May 2014

Roche unveils more plans for plant expansions in Switzerland.
While other drugmakers ar closing plants in the face of patent losses and revenue challenges, Roche ($RHHBY) is steadily expanding its manufacturing network. The company, which is already spending nearly $900 million to pump up its biologics making capabilities, will undertake another couple of projects that will bring its total investment on manufacturing projects to more than $1 billion. The Swiss drugmaker said today that it will invest a total of CHF 120 million ($134.6 million) to build new facilities at its Basel headquarters, as well as make upgrades to existing production operations there. Roche said it will invest CHF 85 million ($95.4 million) to build a new facility for small molecule drugs, which it expects to have operational by Q3 2016. In addition, it will invest another CHF 35 million ($39.3 million ) to expand and upgrade an existing facility to make investigational drugs, as well as some products that are already approved. The drugmaker said the facility should be ready in June 2015 but did not indicate how many jobs might be tied to the expansions. It was more specific in that regard last fall when it rolled out plans for its major expansion for its biologics manufacturing. Roche is the global leader in making cancer products and many of those are biologics, large molecule products manufactured from living cells, like its hot selling Kadcyla, as well as older drugs like Rituxan and Herceptin. The expansion of its biologics production will total more than $880 million for a new facility in Switzerland and expansion of plants in the U.S. and Germany. Those upgrades will roll out over 5 years and it said it expects to add nearly 500 jobs in the process.
http://www.fiercepharma.com/story/roche-unveils-more-plans-plant-expansions-switzerland/2014-05-19, Published 19 May 2014

Roche confirms visit by Chinese authorities.
Roche has confirmed to PharmaTimes that its offices have been visited by Chinese authorities as scrutiny of the pharmaceutical sector increases in the country. The Swiss major said in a emailed statement that “we are aware that local government authorities visited Roche’s office in Hangzhou on May 21 and the details of the visit are not clear. We will collaborate fully with authorities for any inquiries”. Reuters reported that the visit was made by local unit of China’s State Administration for Industry and Commerce, one of the country’s anti-trust regulators which usually specialises in corruption probes. The company’s Shanghai Roche Pharmaceuticals subsidiary was founded in 1994 and has a portfolio of 15 products, covering seven treatment areas in China. News of the visit comes a week after Chinese authorities accused Mark Reilly, former head of GlaxoSmithKline’s operations in the country, of ordering employees to commit bribery following a ten-month investigation. Speaking to Bloomberg, Kevin Jones, a Shanghai-based lawyer at Faegre Baker Daniels, said President Xi Jinping’s government is cracking down on corruption, “so there’ll likely be more cases going forward.” He added that foreign companies “are an easy target because they’re generally held to a higher standard”.
http://www.pharmatimes.com/Article/14-05-22/Roche_confirms_visit_by_Chinese_authorities.aspx, Published 22 May 2014

Takeda, ASKA sign distribution deal for hypertension drug Candesartan ASKA.
Japanese firms ASKA Pharmaceutical (Aska) and Takeda Pharmaceutical (Takeda) have entered into a distribution agreement for Candesartan ‘ASKA’ (candesartan cilexetil), a drug indicated for the treatment of hypertension. Candesartan ASKA is an authorized generic (AG) of Blopress (candesartan cilexetil), which Takeda has licensed the patent to Aska. Aska had received approval for the drug from the Japanese Ministry of Health, Labour and Welfare in February 2014, and is currently applying for listing on the National Health Insurance (NHI) Price List for June 2014. As part of the agreement, Aska will launch and promote Candesartan ‘ASKA’ to healthcare professionals after it is listed on the NHI Price list. Takeda will buy the drug from Aska, and will be responsible for its distribution to wholesalers. In October 2013, Aska had formed a Generics Business Division, which will work jointly with the existing Pharma Business Division to promote the pharmaceutical sales business.
http://contractservices.pharmaceutical-business-review.com/news/takeda-aska-sign-distribution-deal-for-hypertension-drug-candesartan-aska-190514-4269940, Published 19 May 2104

Takeda’s Entyvio gets FDA approval to treat ulcerative colitis, Crohn’s disease.

Japan-based Takeda Pharmaceutical Company (Takeda) and its wholly-owned subsidiary Takeda Pharmaceuticals USA have received approval from the US Food and Drug Administration (FDA) for a new biologic therapy, Entyvio (vedolizumab), to treat adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD). At present, Entyvio is approved for inducing and maintaining clinical response and remission, improving endoscopic appearance of the mucosa. The drug secured the approval to achieve corticosteroid-free remission in adult patients with moderately to severely active UC who have had an inadequate response with, lost response to, or were intolerant to a tumor necrosis factor (TNF) blocker or immunomodulator; or had an inadequate response with, were intolerant to, or demonstrated dependence on corticosteroids. Northwestern University Feinberg School of Medicine medical director Stephen Hanauer said Entyvio is a new option that works to block important contributors to the chronic inflammation that is a hallmark of ulcerative colitis and Crohn’s disease. “The clinical trial program evaluated the efficacy and safety profile of Entyvio and demonstrated that Entyvio has the potential to help adult patients with moderately to severely active UC or CD successfully manage their disease,” Hanauer said. Takeda Pharmaceuticals USA president Douglas Cole said patients with moderately to severely active ulcerative colitis or Crohn’s disease, and the healthcare professionals who care for them, need additional new treatment options. “Entyvio reflects an expansion of Takeda’s commitment to supporting patients with gastrointestinal disorders,” Cole said. The approved dose of Entyvio is 300mg which will be infused intravenously over 30 minutes at zero, two and six weeks, then every eight weeks thereafter. The company said that patients should be observed during infusion and until the completion of the infusion. In March 2014, the company had received a positive opinion for Entyvio to treat adults with moderately to severely active UC and CD from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). Currently, Takeda is awaiting response from the European Commission on approval for Marketing Authorisation of Entyvio. The Biologics License Application (BLA) submission was based on the largest Phase III clinical trial program conducted to date simultaneously evaluating both UC and CD patient populations in four clinical studies involving 2,700 patients in nearly 40 countries.

http://drugdelivery.pharmaceutical-business-review.com/news/takedas-entyvio-gets-fda-approval-to-treat-ulcerative-colitis-or-crohns-disease-210514-4272648, Published 21 May 2014

Teva/Active Biotech MS pill rejected again by CHMP.
Teva Pharmaceutical Industries and partner Active Biotech say they are not giving up on their multiple sclerosis pill Nerventra despite another rejection from advisors to the European Medicines Agency. The EMA’s Committee for Medicinal Products for Human Use (CHMP) has confirmed its opinion from January to recommend against approval for Nerventra (laquinimod). Teva and Active had appealed the decision against the treatment for relapsing-remitting MS but the second review has come up negative again. Teva chief scientific officer Michael Hayden said that “we are disappointed with the outcome of the re-examination and will be working with the EMA to make Nerventra available to MS patients in the EU”. Unlike the CHMP, he added that the companies believe the drug has a favourable risk-benefit profile “and the potential to fulfil an unmet need for a treatment that decreases disability progression, and protects against brain volume loss, two important goals in the management of MS.”Following two late-stage studies, Teva is conducting a third Phase III trial, CONCERTO, evaluating two doses of Nerventra (0.6mg and 1.2mg) in 2,100 patients for up to 24 months. The primary endpoint will be time to confirmed disability progression, the largest MS clinical trial to have this as its goal. In addition, Teva is investigating Nerventra in progressive forms of MS and the first trial for this indication is planned to be initiated soon.
http://www.pharmatimes.com/Article/14-05-23/Teva_Active_Biotech_MS_pill_rejected_again_by_CHMP.aspx, Published 23 May 2014

Valeant says new bid for Allergan will not be an all-cash offer.

Valeant Pharmaceuticals indicated Tuesday that despite recent speculation it’s improved offer to acquire Allergan will not be an all-cash deal. Valeant will announce the new bid on May 28. Earlier this month, Allergan rejected an unsolicited takeover offer from Valeant and activist investor William Ackman’s Pershing Square Capital Management that comprised $48.30 in cash and 0.83 shares of Valeant common stock for each Allergan share.

http://www.firstwordpharma.com/node/1211434?tsid=28&region_id=6#axzz32CDWXHLI, Published 20 May 2014