Prescribed Reading: More portfolios reshuffled
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
Mergers & analysis
Last week was characterized by major restructurings at big names including GlaxoSmithKline and Eli Lilly & Co., and this week's earnings announcements didn't stray from the trend. Teva Pharmaceutical Industries Ltd. disappointed investors by announcing huge cost cutting measures, as its stock races to the bottom of the chart. The company will cut its dividend, lay off as many as 7,000 employees, exit 45 markets and close 15 manufacturing plants. Meanwhile, the Israeli company is still on the hunt for a new CEO — but that job is looking less appealing each and every day.
Shire also is joining this growing trend; the big biotech is looking to shed its neuroscience franchise. Shire has long been a stalwart in the space due to it's ADHD drug Adderall (amphetamine/dextroamphetamine), but is looking to exit and focus more closely on hematology (after the Baxalta acquisition) and its rare disease portfolio.
After AstraZeneca's MYSTIC failure prompted questions at competitor Bristol-Myers Squibb, the big pharma responded by picking up IFM Therapeutics, a privately held biotech that focuses on innate immunity to treat cancer. Bristol-Myers is paying $300 million upfront and as much as $2 billion in potential milestones.
Deals have been few and far between this year, as the industry anxiously awaits what Washington will do with regards to tax reform. Pfizer is still on the sidelines for this reason. Although more deals could be coming, reports emerging this Friday morning cite sources that say Gilead Sciences and GlaxoSmithKline are potentially in a bidding war for United Therapeutics. (The Twitterverse is calling this nonsense, so don't hold your breath waiting for one of these deals to come to fruition.)
In a rare move, Lundbeck A/S and 23andMe Inc. are teaming up to conduct a 25,000-person clinical trial to test the role that genetics plays in depression. Enrollment began this week and the companies expect the trial to take nine months.
In other clinical news, Spark Therapeutics Inc. announced prelimiary results from its Phase 1/2 study of its hemophilia A gene therapy. The biotech is currently waiting on a Food and Drug Administration decision for its first gene therapy, but the market is likely more excited for this one. Hemophilia A, while still a rare disease, presents a much larger market opportunity, and this could offer the first ever functional cure for the blood disorder.
While Spark investors could not be more thrilled, investors in Theravance weren't happy to see mixed results this week for its gastroparesis drug. While the drug is meant to cause gastric emptying, the two higher doses of the drug worked too well and caused diarrhea and vomiting in many patients. For Theravance, it is going to mean striking a real balance between the benefits of this drug and the unappealing side effect profile.
Meanwhile, Cytokinetics Inc. inched forward with the development of its heart failure drug omecamtiv mecarbil. The drug, partnered with Amgen, has been in the clinical stages for an excruciatingly long time. But the smaller biotech is set to earn a milestone from its bigger partner once more patients enter the ongoing Phase 3 study.
The week was chock-full of approvals and regulatory actions. Vertex Pharmaceuticals Inc. continued to expand the patient population for its key cystic fibrosis drug Kalydeco (ivacaftor), prompting the company to up its sales forecast for the year.
AbbVie and partner Johnson & Johnson announced Wednesday afternoon that the FDA approved their blood cancer drug Imbruvica for the treatment of chronic graft-versus-host disease. The drug has been on an upward trajectory since its original approval in 2013, and the new indication gives it a non-oncology patient population to target as well.
After years of no new therapies for acute myeloid leukemia (AML), Celgene secured an approval for its treatment for the cancer, dubbed Idhifa (enasidenib). That approval was followed by the green light for another AML drug from Jazz Pharmaceuticals, which will be marketed under the brand name Vyxeos (daunorubicin and cytarabine).
Follow Lisa LaMotta on Twitter