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Pediatric Approval for MDCO/BMY's Recothrom

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The Medicines Company (MDCO) recently gained US Food and Drug Administration (:FDA) approval for the use of Recothrom in pediatric patients. The FDA expanded Recothrom’s label following the completion of a phase IV open-label, single-group safety and immunogenicity study.

Recothrom, a recombinant thrombin, is a topical hemostat used to control non-arterial bleeding during surgical procedures. With the expansion into the pediatric population, Recothrom can now be used in patients aged one month and above.

We note that The Medicines Co. is collaborating with Bristol-Myers Squibb (BMY) for marketing Recothrom. The company acquired the right to sell, distribute and market Recothrom on a global basis in Feb 2013.

The Medicines Co. made an upfront payment of $105 million plus an option fee of $10 million to Bristol-Myers. Moreover, the company will pay tiered royalties on product sales during the two-year collaboration period. Bristol-Myers is responsible for manufacturing and supplying the product to The Medicines Co. The Medicines Co. has the option to acquire the Recothrom assets.

The Medicines Co. started selling Recothrom from Feb 8, 2013. Recothrom sales in the US were $8.6 million. The expanded patient population should help drive sales. Approval in additional countries should also boost sales.

The Medicines Co. is currently a Zacks Rank #3 (Hold) stock. We expect Angiomax to continue performing well. Moreover, we are pleased to see management actively pursuing in-licensing deals and acquisitions to drive growth. While we are encouraged by the company’s efforts to develop its pipeline, we were disappointed to hear about the discontinuation of the development of phase II candidate, MDCO-2010. Moreover, the delay in the Medicines Co.’s plans for filing for US approval of Ionsys is disappointing.

At present, companies like Anika Therapeutics Inc. (ANIK) and Santarus, Inc. (SNTS), both Zacks Rank #1 (Strong Buy) stocks, look well-positioned.

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