The Medicines Company’s (MDCO - Free Report) stock price decreased more that 5% following the release of briefing documents by the U.S. Food and Drug Administration (FDA) ahead of the review by its Cardiovascular and Renal Drugs Advisory Committee (CRDAC). The FDA panel is scheduled to review the New Drug Application (NDA) for The Medicines Co.’s cangrelor, an intravenous anticoagulant, on Feb 12, 2014.
The company is looking to get cangrelor approved for the reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) and in patients requiring bridging from oral antiplatelet therapy to surgery. A response from the FDA on cangrelor’s marketing application is expected by Apr 30, 2014.
Reviewer Against Approving Cangrelor
In the briefing document while two of the reviewers recommended the approval of cangrelor, one of the reviewer was of the opinion that the candidate should not be approved and suggested that an additional study be conducted. Issues related to uncertain non-inferiority of cangrelor versus Bristol-Myers Squibb Company (BMY - Free Report) and Sanofi’s (SNY - Free Report) Plavix (clopidogrel) and ethical misconduct in the CHAMPION trial were raised. We note that the NDA for the candidate was submitted on the basis of encouraging data from four studies – CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE – which evaluated more than 25,000 patients with CAD.
We are disappointed with the issues raised in the FDA’s briefing document. We believe that chances of cangrelor gaining an outright approval are low. We also remain concerned about cangrelor’s sales potential, on approval, given the stiff competition in the anticoagulant market. The market is also highly genericized.
The Medicines Co. carries a Zacks Rank #3 (Hold). A better-ranked stock is Actelion Ltd. with a Zacks Rank #1 (Strong Buy).