The FDA accepted the biologic license application (BLA) for
The Medicines Company
) dry powder formulation of Fibrocaps. The Medicines Co. is
looking to get Fibrocaps approved to help in hemostasis during
surgery, where control of mild or moderate bleeding by
conventional means is ineffective or impractical.
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A final decision on the approval of Fibrocaps is expected by Jan
31, 2015. We note that in Aug 2013, the company announced
positive results from the phase III study (FINISH-3; n=719) on
Fibrocaps. The candidate met all primary and secondary hemostasis
efficacy endpoints in four separate surgical indications − spinal
surgery, hepatic resection, soft tissue dissection and vascular
surgery. Fibrocaps is under review in the EU.
The Medicines Co. believes that Fibrocaps' peak sales could
exceed $300 million provided it gains approval in major markets.
On approval, Fibrocaps will be the company's second hemostatic
product in the market. The company already has Recothrom in its
portfolio which is approved in the U.S. to be used as a topical
hemostat to control non-arterial bleeding during surgical
We are encouraged by the company's progress with its late stage
candidates. With Fibrocaps' BLA acceptance in the U.S., The
Medicines Co. has several candidates under review in the U.S. and
EU. The company expects six new product launches in the next
couple of years. We expect investor focus to remain on the
development of these candidates in the coming quarters.
The Medicines Co. carries a Zacks Rank #3 (Hold). Some
better-ranked stocks in the biotech sector include
Gilead Sciences Inc.
Alexion Pharmaceuticals, Inc.
). All the stocks carry a Zacks Rank #1 (Strong Buy).