MDCO Progresses with Fibrocaps - Analyst Blog


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The Medicines Company ( MDCO ) received encouraging news when the European Medicines Agency (EMA) accepted its marketing authorization application (MAA) for pipeline candidate Fibrocaps, for review.

Fibrocaps, a dry powder topical formulation of fibrinogen and thrombin, is developed to stop bleeding during surgery.

The MAA was submitted on the basis of positive results from a phase III study, FINISH, wherein Fibrocaps was evaluated as an adjunct to hemostasis in patients undergoing surgical procedures. The study used Fibrocaps to control mild or moderate bleeding when conventional surgical techniques were ineffective.

The study met primary and secondary hemostasis efficacy endpoints in four distinct surgical indications of spinal surgery, hepatic resection, soft tissue dissection and vascular surgery.

Meanwhile, The Medicines Co. plans to submit its biologics license application (BLA) for Fibrocaps to the United States Food and Drug Administration (FDA) in the first quarter of 2014.

Additionally, the company also plans to submit a 510(k) application with the FDA for the approval of a complementary spray delivery device meant for the accurate application of Fibrocaps. This device was recently granted a CE mark in Europe.

We note that Fibrocaps was added to The Medicines Co.'s pipeline when it acquired the Dutch company, ProFibrix B.V., in Aug 2013. The company acquired ProFibrix following the announcement of positive phase III data on Fibrocaps.

We believe, Fibrocaps, if approved, may have an advantage over the existing products, as it can be used at room temperature and does not require thawing before use. The Medicines Co. believes that Fibrocaps peak sales could exceed $300 million provided it gains approval in major markets.

The Medicines Co. is a Zacks Rank #3 (Hold) stock. At present, companies like Actelion Ltd. ( ALIOF ), AMAG Pharmaceuticals, Inc. ( AMAG ) and Amgen Inc . ( AMGN ) look attractive. While Actelion carries a Zacks Rank #1 (Strong Buy), both AMAG Pharma and Amgen are Zacks Rank #2 (Buy) stocks.


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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

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