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
- Hep C patent battle rages on
- Amazon jumps into the OTC game
- Express Scripts, Walgreens looks to lower biosimilar costs
Mergers & analysis
There was a flurry of smaller deal activity this week as big biotechs and pharmas made bolt-on acquisitions that will help beef up certain areas of their pipelines. Gilead Sciences Inc. continues to flesh out its cell therapy capabilities after its $11.9 billion acquisition of Kite Pharma last year. The big biotech has linked up with gene therapy stalwart Sangamo Therapeutics, paying $150 million upfront and promising more than $3 billion in milestones. The development partnership will help Gilead develop the next generation of cell therapies, building on the work that was brought in-house from Kite.
Merck & Co. added to its immuno-oncology pipeline with the $400 million acquisition of Australian drugmaker Viralytics Inc. The company's lead drug candidate is already being tested in combination with Merck's immunotherapy blockbuster Keytruda (pembrolizumab). The deal suggests Merck has faith in the Cavatek-Keytruda combo and that the big pharma could gain more favorable economics from having the other drug under its umbrella.
Japanese pharma Takeda Pharmaceutical Company Limited could dole out as much as $2 billion for genetic disease biotech Wave Life Sciences Ltd. to discover, develop and commercialize nucleic acid therapies for central nervous system disorders, buffering the swath of research the company is already doing in the space.
After a devastating week for Alzheimer's disease research, AbbVie Inc. has tapped Voyager Therapeutics Inc. to discover a one-time gene therapy to treat the damaging neurological disease. While the attempt might be far-fetched, the investment shows that at least some big pharmas are still hopeful that the Alzheimer's puzzle can be solved.
Clinically relevant
Two underserved therapeutic areas got a needed shot in the arm from positive clinical trial data this week. AbbVie reported positive results from a Phase 3 trial of its uterine fibroid drug elagolix. While women make up just about half of the world's population, their health issues are largely ignored by the pharmaceutical industry, with only a handful of large companies doing any work in the space.
Elsewhere, Aimmune Therapeutics Inc. announced its long-awaited peanut allergy data. The efficacy data was overwhelmingly positive, knocking down competitor DBV Technologies, which reported meager efficacy for its peanut allergy patch not so long ago. Yet, the Aimmune therapy did show some signs of adverse reactions — which is not totally unexpected with a therapy that's meant to build up a tolerance in allergic patients. The market reacted poorly to the safety stats, but the Food and Drug Administration may react much more favorably.
Highly regulated
A recent report from consulting firm PwC showcased just how much things have changed at the FDA under Commissioner Scott Gottlieb. The industry has been talking for months about how drug approvals have increased — for both branded and generic drugs. But the report also pointed out that while warning letters from the FDA as a whole decreased, the Center for Drug Evaluation and Research increased its output of the cautionary letters as manufacturers struggle to maintain quality control at manufacturing sites.
An FDA approval this week could help shake up the closely watched battle of immuno-oncology drugs in the lung cancer space. AstraZeneca plc gained an additional indication for its PD-L1 inhibitor Imfinzi (durvalumab) to treat unresectable stage 3 patients with non-small cell lung cancer (NSCLC) whose disease has not progressed following concurrent platinum-based chemo- and radiation therapy. While it's not the coveted first-line indication, it could give the runner-up immunotherapy a piece of the rather large lung cancer market.