Every Friday, Seeking Alpha's Biotech Weekly highlights the editors' picks of the week's Seeking Alpha analysis, as well as a review of the top Breaking News stories. What should the Seeking Alpha community be reading and writing about? Please leave a comment to let us know.
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And now, on to the week's news and analysis.
Seeking Alpha Analysis You Should Check Out
- Examining Gilead Sciences' Future Pipeline, by Alexander J. Poulos
- Auspex Hits Home Run With Phase 3 Data In Huntington's Chorea, by Jason Napodano, CFA
- Cubist Pharmaceuticals: An Extraordinary Arbitrage Opportunity, by Shareholder Boar (SA PRO article)
- Juno Therapeutics: Saving The Best Biotech IPO For Last In 2014, by Chris Katje
- Top Ideas From The San Antonio Breast Cancer Symposium, by Daniel Ward (SA PRO article)
- NewLink Genetics: Examining Likelihood Of Success In The IMPRESS Trial, by Mind Craft
- Medivation Poised To Expand As Xtandi Shows Efficacy In Advanced Triple Negative Breast Cancer, by Stock Doctor
- DaVita Healthcare's Outlook For 2015: Don't Overstay The Festivities, by Cheryl Swanson
- Geron Enters 2015 On A More Assured Note, by Kanak Kanti De
- Cyclacel Now An Exercise In Futility, by Stephen Simpson, CFA (SA PRO Article)
Here are some of the top breaking news items of the week.
- Merck (NYSE:MRK) acquires privately-held Lausanne, Switzerland-based Oncoethix for an upfront payment of $110M and up to an additional $265M in clinical and regulatory milestones.
- Oncoethix's lead product is OTX015, a BET bromodomain inhibitor (2,3,4) currently in Phase 1b development for the treatment of hematological malignancies and advanced solid tumors.
A Phase 3 clinical trial assessing the safety and efficacy of GlaxoSmithKline's (NYSE:GSK) HZ/su investigational vaccine for the prevention of shingles met its primary endpoint of overall vaccine efficacy across all age cohorts compared to placebo. In patients aged 50 years and older, HZ/su reduced the risk of shingles by 97.2% compared to control. The trial, started in August 2010, in ongoing in 18 countries and involves more than 16,000 patients.
An interim analysis for futility performed by the independent Data and Safety Monitoring Board (DSMB) finds that Cyclacel's (NASDAQ:CYCC) lead product candidate, sapacitabine, will be unlikely to demonstrate a statistically significant improvement in survival in a Phase 3 trial in acute myeloid leukemia. The DSMB recommended that patients remain on treatment, though, since it saw no safety issues.
Opko Health (NYSEMKT:OPK) is up 14% premarket on robust volume in response to its deal with Pfizer (NYSE:PFE). The latter will be pay Opko an upfront fee of $295M and up to $275M in regulatory milestones for the global rights to hGH-CTP, a long-acting growth hormone. Its value proposition is a once-weekly injection, a significant improvement over the once-daily standard of care.
- According to Bloomberg, Amgen (AMGN +1%) intends to charge $178,000 per standard course of treatment for its blood cancer therapy, Blincyto (blinatumomab). The price assumes two cycles of treatment at $89,000 per cycle, the median duration of treatment for patients who responded to therapy in clinical trials.
- For comparison purposes, Merck's (MRK +0.7%) Keytruda (pembrolizumab) costs $150,000 per year and Bristol-Myers Squibb's (BMY +2.2%) Yervoy (ipilimumab) costs $120,000 per course.
- Germany's healthcare cost watchdog, the German Institute for Quality and Efficiency in Health Care, determines that Bayer's (OTCPK:OTCPK:BAYRY +0.9%) (OTCPK:BAYZF) eye drugEylea (aflibercept) offers no additional benefit over Novartis' (NVS -0.6%) Lucentis(ranibizumab) for the treatment of diabetic macular edema. The agency's decision could affect the amount of reimbursement for Eylea.
- In January, the Institute came to the same conclusion for the indication of macular edema. Last year, it determined that it could not assess the potential advantages of Eylea in wet age-related macular degeneration because Bayer has not provided the relevant data.
- Eylea was developed by Regeneron Pharmaceuticals (REGN -1.5%) and licensed to Bayer in ex-U.S. territories.
- Roche's (OTCQX:) Genentech submits a New Drug Application (NDA) to the FDA for cobimetinib in combination with Zelboraf (vemurafenib) for the treatment of patients with BRAF V600 mutation-positive advance melanoma.
- Cobimetinib selectively blocks the activity of MEK, one of a series of proteins that make up a signaling pathway that helps regulate cell division and survival. Vemurafenib binds to mutant BRAF, another protein in the pathway, to interrupt abnormal signaling that can cause tumors to grow.
Other stories of note:
- Juno sets price of IPO
- Europe advisory committee gives thumbs up to Orexigen obesity med
- Roche pulls plug on development of Alzheimer's drug
- FDA clears Myriad's companion diagnostic test for Lynparza
- PDUFA date approaches for Cubist antibiotic combo
- Pfizer commences Phase 2 study in Duchenne Muscular Dystrophy
- ImmunoGen tanks on Roche Phase 3 failure
- BioLineRx teams up with Novartis
- Bellicum IPO off to a strong start
- Investors punish Sophiris
Disclosure: The author has no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
The author wrote this article themselves, and it expresses their own opinions. The author is not receiving compensation for it. The author has no business relationship with any company whose stock is mentioned in this article.
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