Bio Roundup: Mylan’s Shock, Hillary’s 3%, Duchenne Lessons & More

Xconomy National — 

It was the tweet heard around the biotech world, again. Mylan bumped up the price of the EpiPen 400 percent, presidential nominee Hillary Clinton responded with a tirade against drug price hikes, and—much like when Clinton railed against drug pricing last year—biotech indexes promptly plummeted more than 3 percent.

Last year, Clinton’s target was Martin Shkreli and Turing Pharmaceuticals, which boosted by 5000 percent the price of an anti-parasitical drug often used by HIV patients. No surprise, Shkreli weighed in during the media frenzy with support for Mylan.

Drug pricing rhetoric had dissipated over the past few months, leading to a steady biotech rally over the summer. But with the presidential election now just over two months away, the EpiPen brouhaha has put the drug industry back in political crosshairs once again. That and the rest of this week’s biotech headlines below.

—Mylan (NASDAQ: MYL), which last year completed a so-called “tax inversion” to move to the Netherlands and a lower tax bill but still has U.S. operations in Canonsburg, PA, was taken to task this week for raising the list price of its EpiPen epinephrine injections, a critical emergency treatment for people with life-threatening allergies. Its latest hike has brought the two-pack of injectors to more than $600, according to the Wall Street Journal. Critics say Mylan has been emboldened by the recall of EpiPen’s only competition last fall. In response, Mylan has offered more discounts and rebates, but it has not lowered the list price. Mylan CEO Heather Bresch said Thursday on CNBC that much blame for the cost hike falls upon middlemen, like pharmacy benefit managers.

—Any day now, the FDA could approve or reject a Duchenne muscular dystrophy drug from Cambridge, MA-based Sarepta Therapeutics (NASDAQ: SRPT). The decision has significant ramifications, one of which being it could set a benchmark for the regulation of rare disease treatments. The situation highlights a complex issue in healthcare, and advocates for patients with another rare disease, spinal muscular atrophy—which could see its first approved drug next year—have watching the situation closely.

—Pfizer won the auction for San Francisco cancer drug maker Medivation (NASDAQ: MDVN) with a $14 billion all-cash bid—at $81.50 a share, it was $5 billion higher than the hostile offer Sanofi made for Medivation earlier this year. Whether Medivation will be worth the price remains to be seen. The company shares rights to its lead drug enzalutamide (Xtandi) with Astellas Pharma and its second drug, talazoparib, a type of cancer treatment called a PARP inhibitor, awaits crucial Phase 3 data next year.

—More PARP-a-palooza: Shares of Clovis Oncology (NASDAQ: CLVS) surged more than 27 percent after the Boulder, CO-based company said that the FDA has begun a review of its PARP blocker rucaparib in ovarian cancer. An approval decision should arrive by Feb. 23. Rucaparib represents a second chance for Clovis, which scrapped its lung cancer drug rociletinib in May in the wake of a data revision fiasco.

—Pfizer wasn’t done after scooping up Medivation. Two days later, it paid AstraZeneca $550 million upfront for the rights to a group of antibiotics either already on the market or in late-stage testing. The deal also includes a $175 million deferred payment due in 2019 and $850 million in downstream payouts tied to regulatory and sales targets.

—Amgen (NASDAQ: AMGN) of Thousand Oaks, CA, said that the FDA rejected its drug etelcalcetide (Parasbiv), a treatment for patients with an excess of damaging hormone release because of chronic kidney disease. The company gave no reason for the rejection.

—A five-day workshop in Washington, D.C., on boardroom skills for women executives in biotech announced its 20 participants. The program, “Boardroom Ready,” is funded in part by LifeSci Advisors, the investor relations firm that sparked a furor by hiring female models to mingle at its J.P. Morgan party. The firm has since pledged to help close the gender gap among biotech leadership.

—South San Francisco, CA-based Denali Therapeutics, with ambitions to develop drugs for several neurodegenerative diseases, bagged $130 million in a Series B and unveiled a series of deals. Part of the cash, which adds to the firm’s $217 million Series A, will go toward its first clinical trial, set to begin in Europe after a regulatory green light.

—Cambridge-based startup Amylyx Pharmaceuticals raised a $5 million Series A round from Morningside Venture, the ALS Investment Fund, and former Genzyme CEO Henri Termeer to develop a drug meant to stop the death of nerve cells in patients with amyotrophic lateral sclerosis. A Phase 2 trial of the drug, AMX0035, should start in late 2016 or early 2017.

—Theranos, of Palo Alto, CA, plans to appeal sanctions the Centers for Medicare and Medicaid Services placed on its Newark, CA, lab last month.

—Cambridge-based PixarBio is raising $30 million in a reverse merger with an undisclosed public entity. It will retain the PixarBio name and aims to start trading on the over-the-counter market during the second week of September. PixarBio, which counts MIT’s Bob Langer among its founders, is developing a non-addictive alternative to morphine for post-surgical pain.

—San Carlos, CA-based BioCardia will also go public via a reverse merger, four months after dropping plans for an IPO.

—David Holley profiled the career of George Peoples, a prolific surgeon and war veteran now devoting his time to cancer vaccine research.

—Novan, a Durham, NC, company that aims to develop nitric oxide-based drugs for an array of skin conditions, filed for an IPO. Frank Vinluan has more on Novan, which relied on a variety of high net worth individuals, rather than venture firms, to get to this point.

—Tarrytown, NY-based Regeneron Pharmaceuticals (NASDAQ: REGN) will work with the Biomedical Advanced Research and Development Authority to develop antibody drugs for the prevention and treatment of Middle East Respiratory Syndrome, or MERS. Regeneron already has an agreement with BARDA on an Ebola-fighting antibody that recently began early stage clinical testing.

Alex Lash contributed to this report.