The FDA accepted the biologic license application (BLA) for The Medicines Company’s (MDCO - Free Report) 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.
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 procedures.
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. (GILD - Free Report) , Actelion Ltd. and Alexion Pharmaceuticals, Inc. (ALXN - Free Report) . All the stocks carry a Zacks Rank #1 (Strong Buy).