Let's take a look at today's top stories in biotech and health care. Keep an eye out for The Medicines Company (MDCO), Omeros Corp. (OMER 0.98%), Opko Health (OPK) and VIVUS, (VVUS).
FDA accepts The Medicines Company's Biologic License Application for Fibrocaps
The Medicines Company has announced that the U.S. Food and Drug Administration, or FDA, has accepted a biologic license application, or BLA, for its experimental bleeding treatment called Fibrocaps. Fibrocaps is a dry powder formulation of fibrinogen and thrombin used during surgery to control bleeding when more conventional means are impractical or ineffective. The Medicines Company bought ProFibrix B.V. last year primarily to acquire Fibrocaps while it was in late-stage testing. And last August, Fibrocaps reported positive results from a large late-stage trial that is the basis of this BLA filing. The drug's regulatory review is expected to be complete by January 31, 2015, Fibrocaps' preliminary PDUFA target action date. What's key to understand is that the entire hemostat market is estimated to be around $1 billion. So, an approval would obviously be beneficial to a company with a $1.6 billion market cap, but you shouldn't expect it to be a game-changing development.
Omeros Corp. cleared for mid-stage studies for OMS721
Omeros Corp. announced this morning that the FDA has accepted their Investigation New Drug Application for OMS721, a drug indicated for mediated thrombotic microangiopathies, or TMAs. TMAs are a rare type of blood disorder characterized by clotting in multiple organs. This regulatory clearance allows Omeros to proceed with a host of mid-stage trials for the drug, with one expected to begin this quarter. While this is certainly good news, you should keep in mind that Omeros already has a full plate in terms of clinical trials and the commercialization of Omidria. Put simply, Omeros may have to raise yet more capital to further OMS721's clinical development, especially if the company decides to aggressively pursue this drug across multiple indications.
Opko Health insiders keep buying
Insider buying is usually a good indicator that management believes in the future of the company, and investors would be wise to pay attention. In Opko's case, Director Phillip Frost, who already owns about 10% of the company, made yet another series of purchases of his own company on the open market yesterday. Insiders have now made 50 buys compared to only 4 sales on the open market in the last three months, with the majority of buys being made by Mr. Frost. These insider buys come on the back of the commercial launch of 4Kscore Test, the company's prostate cancer diagnostic test, suggesting that management is rather optimistic about the test's commercial prospects.
VIVUS continues to slide
Shares of VIVUS are down close to 6% in premarket this morning after Piper Jaffray downgraded the stock to Underweight and gave it a price target of $3.00. Although this downgrade suggests the stock is currently overvalued by as much as 50%, I believe it may be warranted. The company's flagship anti-obesity medication, Qsymia, simply isn't gaining traction, and a marketing partner hasn't been forthcoming. Sales of the company's erectile dysfunction drug have also been unimpressive to date. Overall, VIVUS's management needs to figure a viable way forward to stop this continued slide. Regarding the anti-obesity market, Qsymia is rapidly falling behind Arena Pharmaceuticals' (ARNA) Belviq in terms of promotional efforts and sales. With TV ads to start soon for Belviq, this gap looks like it may only continue to widen.
