Good news continues to flow in for The Medicines Company MDCO on the regulatory front with the FDA finally approving the company’s intravenous antiplatelet agent, Kengreal (cangrelor). Kengreal is approved for use as an adjunctive therapy to percutaneous coronary intervention (PCI) for reducing periprocedural thrombotic events in patients who have neither been treated with a P2Y12 inhibitor nor have been given a glycoprotein IIb/IIIa inhibitor.
FDA approval was largely expected as the Cardiovascular and Renal Drugs Advisory Committee had issued a favorable opinion in Apr 2015. We note that Kengreal’s path to approval was not exactly smooth with the company receiving a complete response letter for the drug in Apr 2014 in response to its original regulatory filing. The Medicines Co. had in-licensed the drug from AstraZeneca AZN in 2003.
The Medicines Co. expects the drug to hit the market as early as July. We remind investors that Kengreal also gained EU (trade name: Kengrexal) approval in late March this year for the PCI indication.
The FDA approval of Kengreal comes as a major boost for The Medicines Co. considering that its flagship product, Angiomax, which accounted for almost 83% of total revenues in the U.S. in 2014, is facing generic threat. Taking into account the number of PCI procedures requiring antithrombin and antiplatelet therapy, we believe Kengreal holds significant commercial potential.
Meanwhile, the last few months have been particularly eventful for The Medicines Co. on the regulatory front. While Ionsys (acute postoperative pain) and a new formulation of Minocin IV (infection) gained approval in the U.S., Orbactiv (infection) received approval in the EU. Raplixa (to stop bleeding during surgery) gained approval both in the U.S. and EU. The Medicines Co. is gearing up for the launch of these products, expected in the next few quarters.
The Medicines Co. carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector include Gilead Sciences Inc. GILD and Hospira Inc. HSP. Both hold a Zacks Rank #1 (Strong Buy).
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