Prescribed Reading: Avelumab OK'd, Ultragenyx fails trial
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
- J&J, GlaxoSmithKline pull ads from YouTube.
- PTC adds to its problems with Emflaza.
- Biogen keeps Tecfidera generics at bay.
Mergers & analysis
There’s that little argument going on in Washington about the future of healthcare in the U.S. Check out our sister publication Healthcare Dive for the latest going on with that.
Meanwhile, pharma is still reeling over the most recent comments from President Trump about making prescription drug prices in the U.S. the lowest in the world — something that is a near impossibility.
Despite all of the distractions from Washington, business continues as usual. Bristol-Myers Squibb upped its partnership with West Coast biotech CytomX for eight new prodrug targets. The original deal was inked in 2014 with a $50 million up-front, but Bristol-Myers is so pleased with the work that it’s throwing in another $200 million and the new deal value is now worth $3.75 billion — not bad for a company that doesn’t really have much in the clinic.
In a daring move, Dare Biosciences is acquiring a controlling stake in plagued Cerulean Pharma. The blue biotech has been searching for alternatives since its lead candidate failed in a mid-stage study last summer. Along with the takeover by Dare, Cerulean is cutting staff and selling off some of its other assets.
Ultra-rare disease company Ultragenyx took a hit to its stock price this week when its seizure med failed to best a placebo in a mid-stage study. The rare disease drugmaker said in a March 22 statement it plans to continue an ongoing Phase 3 evaluating the candidate as a treatment for Glut1 DS patients demonstrating motor disorders.
New clinical results published in the Journal for the American Medical Association showed that the “low-T” craze of a few years ago was indeed perpetuated by direct-to-consumer advertising. While this may not be the most surprising conclusion, it certainly gives the DTC haters some more fuel for the fire against advertising directly to patients. This practice is generally frowned upon in the rest of the world, and the U.S. has faced heat for the practice. In the case of testosterone therapies, pharma companies essentially created a condition (that had no scientific evidence behind it) to drive sales. It turned out the drug they were pushing not only didn’t treat the nonexistent condition, but also could cause severe side effects such as heart attack, stroke and liver toxicity.
Pfizer has officially joined the checkpoint inhibitor race. The big pharma and its partner, Merck KGaA, garnered Food and Drug approval for their PD-L1 inhibitor avelumab. The drug will be marketed under the name Bavencio, which prompted the peanut gallery on Twitter to wonder if it was named for a city in the Swiss Alps or a Harry Potter spell.
Bavencio was approved in a rare skin cancer, a small indication that will allow the companies to pursue other, larger indications more quickly. It also has the added benefit of being an orphan indication and comes with the market exclusivity perks that the Orphan Drug Act provides.
The PD-L1 inhibitor is the fourth to market in the class and will have a lot of catching up to do if it is going to get anywhere near Bristol-Myers’ Opdivo (nivolumab) or Merck & Co’s Keytruda (pembrolizumab).
In smaller drug news, Newron Pharmaceuticals grabbed a FDA ok for Xadago (safinamide). Xadago is designed to reduce the duration of "off time," or time with decreased motor functioning, for Parkinson's patients already on optimized standard therapy. The add-on therapy is the first Parkinson’s therapy to be approved in more than a decade.
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