The Medicines Company
) 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.
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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
) 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
The Medicines Co. carries a Zacks Rank #3 (Hold). A better-ranked
) with a Zacks Rank #1 (Strong Buy).