Prescribed Reading: Merger as a band-aid for biotech troubles
A weekly guide to the goings-on in the biopharma industry.
Biopharma is a complex, rapidly evolving industry that is highly regulated and closely watched — and that means there is constant news. Here's a closer look at the clinical trials, M&A, cool science and regulations that are driving the industry this week.
In case you missed it
- Tesaro gains in PARP race, but still behind Lynparza
- Mylan cuts forecast due to pricing pressure
- Novo Nordisk leans heavily on Victoza
Mergers & analysis
Deals continue to trickle in as the lazy days of summer come to a close. Two small biotech mergers were announced this week, as privately held companies are using this opportunity to go public without an initial public offering.
The highly troubled Galena Biopharma Inc. finally found a buyer for its assets, merging with closely held Sellas Life Sciences Group Ltd. Galena has had a swath of headaches in recent years, including a CEO departure amidst a criminal investigation, some bad data for lead product, and layoffs. The merger will give holders of Sellas a majority stake in the company, and the new company will shake off the bad vibes of Galena by taking on the Sellas name and new ticker symbol on the NASDAQ.
Another troubled biotech is also shaking off its name and starting a new life through a merger. Cempra Inc. announced this week that it will combine with privately held Melinta Therapeutics Inc. after its lead product was rejected by the Food and Drug Administration earlier this year, sending shares spiraling. The new company will have the Melinta name and will combine the anti-infective pipelines of both companies.
Swiss Pharma Roche AG is culling its pipeline — a move many big pharmas have been making in recent months as they re-prioritize to focus on more promising assets in their pipelines. But as the saying goes, one man's trash is another man's treasure. In this case, Dermira Inc. will pay $80 million upfront to gain rights to Roche's IL-13 blocker lebrikizumab for atopic dermatitis.
Celgene and Sutro Biopharma rejiggered a deal that they first struck in 2012, with the big biotech opting not to exercise its license to buy the smaller partner. Celgene will retain its stake in Sutro, which is at about 15% currently, and will still have access to four programs that Sutro is developing.
Alnylam Pharmaceuticals Inc. continued to disappoint investors when it failed this week to give some clear answers about the deaths related to the RNA interference treatment revusiran — reported last year — prior to discontinuation of the program. While a subsequent investigation revealed no definitive answers, Alnylam found no evidence of drug-related cardiotoxicity.
Galapagos NV trumpeted solid results for its idiopathic pulmonary fibrosis drug this week, but a small patient population and a short trial had investors questioning just how reliable the data might be. The data comes on the heels of positive results from competitor FibroGen Inc., which showed its drug could improve lung function and be used in conjunction with other IPF drugs.
Two companies this week also reported data for their bad cholesterol lowering drugs — one wowed investors, while the other was a bit of a flop. Esperion Therapeutics Inc.'s drug lowered LDL cholesterol drugs by 64%, while Gemphire Therapeutics Inc.'s drug only lowered the bad cholesterol by an average of about 17%. Regardless of how effective these drugs (or are not), might not even be a factor. The class of PCSK9 inhibitors currently on the market have shown there may not be a commercial market for any of these new cholesterol lowering compounds.
The opioid crisis has reached a fever point, with President Donald Trump saying he will declare the problem a national public health emergency. Also this week, the Drug Enforcement Agency said its considering reducing the Aggregate Production Quota for opioid painkiller manufacturing for next year, dropping the level by 20%.
Elsewhere, Vernalis was hit with a Complete Response Letter (CRL) from the FDA for its cough and cold med. This is the second one this year; previously, another one of the company's cough and cold drugs was rejected. The company noted that the original problem had not been fixed.
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