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.
Late last week, The Medicines Company (MDCO) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued positive opinions regarding the marketing authorization for three of its candidates – Orbactiv (oritavancin), Raplixa (sealant powder) and Kengrexal (cangrelor). Shares have been up 3.2% since the announcement.
The CHMP’s recommendation in favor of commercialization of these candidates is good news for The Medicines Co. Particularly, positive opinion for Kengrexal (being developed for the prevention of platelet activation and aggregation that leads to thrombosis in the acute care setting including patients undergoing percutaneous coronary intervention) is encouraging. We remind investors that the candidate received a complete response letter from the FDA in Apr 2014.
Meanwhile, The Medicines Co. has several new submissions under review in the U.S. or Europe or both. Currently, Raplixa is under FDA review for use as an aid to stop bleeding during surgery. Additionally, a supplemental new drug application for Ionsys, which is being developed for short-term management of acute postoperative pain, is under FDA review with an action expected by Apr 30, 2015. Marketing authorization for the candidate is also under review in the EU.
We note that Orbactiv is already approved in the U.S. for the treatment of acute bacterial skin and skin structure infections caused or suspected to be caused by susceptible isolates of the various gram-positive microorganisms including Staphylococcus aureus.
We are pleased with the CHMP’s positive opinion on three candidates all at once. We expect investor focus to remain on regulatory updates from the company.
The Medicines Co. carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Celgene Corp. (CELG), Regado Biosciences, Inc. (RGDO) and Alexion Pharmaceuticals, Inc. (ALXN). All these stocks hold a Zacks Rank #1 (Strong Buy).
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