With the SPDR S&P Biotech Index up 37% over the trailing-12-month period, it’s evident that investment dollars are willingly flowing into the biotech sector. Keeping that in mind, let’s have a look at some of the rulings, studies, and companies that made waves in the sector last week.
You can forget all about earnings reports this week, because we had more than enough clinical data, Food and Drug Administration panel reviews, and FDA decisions to last us for a long time. In fact, things were so busy that I’m splitting this week’s review into two parts. Let’s first look at any and all FDA actions this week.
This week’s lone PDUFA decision by the Food and Drug Administration turned out to be a disappointment for Allergan, Inc. (NYSE:AGN) shareholders, as inhaled migraine medication Levadex was rejected for a second time. Once again, the FDA expressed concerns about Allergan, Inc. (NYSE:AGN)’s manufacturing partner Exemplar Pharma, which it recently purchased for less than $20 million. It’s likely that the FDA will want to reinspect the facility before approving Levadex, but from a safety and efficacy standpoint, there doesn’t seem to be anything that would stand in the way of its eventual approval.
The FDA’s panels were also very busy this week, dishing out their recommendations and findings on three separate biotech companies.
Theravance Inc (NASDAQ:THRX) and GlaxoSmithKline plc (ADR) (NYSE:GSK) both jumped considerably this week following a positive recommendation from the FDA’s panel regarding their inhalable long-term COPD treatment, Breo Ellipta. Breo is a powdered combination of Theravance Inc (NASDAQ:THRX)’s long-acting beta-2 agonists with GlaxoSmithKline plc (ADR) (NYSE:GSK)’s long-acting muscarinic antagonists, and it’s delivered through a device known as Ellipta. The FDA’s panel on Wednesday recommended approval for Breo by a vote of 9-4, noting that it reduced COPD exacerbations and aided airflow in obstructed pathways. The panel also voted 10-3 that Breo was safe given the indications it was aiming to be approved for. With multibillion-dollar sales potential, this is another big step for Theravance Inc (NASDAQ:THRX) and a sign of relief for GlaxoSmithKline plc (ADR) (NYSE:GSK) shareholders.
Finally, Sarepta Therapeutics Inc (NASDAQ:SRPT) found itself on the short end of the stick after it announced what investors construed as mixed results from a discussion with the FDA over its Duchenne muscular dystrophy drug hopeful, eteplirsen. Sarepta Therapeutics Inc (NASDAQ:SRPT) is attempting to gain accelerated approval for its DMD drug following exemplary mid-stage test results, but first the FDA would first like the company to justify why dystrophin (a protein whose production is encouraged by taking eteplirsen) should be an acceptable endpoint and predictor of clinical benefit. It also requested additional safety data as part of the accelerated review process. Some on the Street have seen this as the FDA’s unwillingness to approve a drug that’s been tested on such a small sample size. Then again, the FDA’s wish to review additional data, should Sarepta Therapeutics Inc (NASDAQ:SRPT) meet its request, signifies to other investors its willingness to possibly push eteplirsen through the process.
The article This Week in Biotech: Part 1 originally appeared on Fool.com is written by Sean Williams.
Fool contributor Sean Williams has no material interest in any companies mentioned in this article. You can follow him on CAPS under the screen name TMFUltraLong, track every pick he makes under the screen name TrackUltraLong, and check him out on Twitter, where he goes by the handle @TMFUltraLong.The Motley Fool has no position in any of the stocks mentioned.
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