EU Review for The Medicines Co.'s Oritavancin

Zacks

Updates on the regulatory front are eagerly awaited by investors in the pharma/biotech sector as they impact the share price of the concerned company. Regulatory updates include events like filing of marketing applications, acceptance of these applications for review by the regulatory agencies, reviews by advisory panels and finally, a response from the regulatory agency regarding the approval status.

An update on the regulatory front was provided last week by The Medicines Company (MDCO), which said that its marketing authorization application (MAA) for its investigational antibiotic, oritavancin, has been accepted by the European Medicines Agency (:EMA) for review. The company is looking to get oritavancin approved for the treatment of complicated skin and skin tissue infections (cSSTI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (:MRSA).

Oritavancin is a lead candidate in The Medicines Co.’s pipeline and is in the late stage of development. This intravenously administered antibiotic is being developed for the treatment of acute bacterial skin and skin structure infections (:ABSSSI) caused by gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (:MRSA).

Oritavancin is currently under review in the U.S. as well with a response expected by August 6, 2014. The candidate has Qualified Infectious Disease Product (:QIDP) designation in the U.S.

Meanwhile, in addition to oritavancin, the company currently has cangrelor under FDA review. However, at present, Cangrelor’s chances of gaining FDA approval look low as earlier this month, the FDA’s Cardiovascular and Renal Drugs Advisory Committee voted against approving the investigational antiplatelet agent. Although the FDA is not required to follow its panel’s advice, it usually does so. A final response from the FDA should be out by Apr 30, 2014.

The Medicines Co. carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Alexion Pharmaceuticals, Inc. (ALXN), Emergent BioSolutions, Inc. (EBS) and Gilead Sciences Inc. (GILD). All these stocks carry a Zacks Rank #1 (Strong Buy). 

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