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FDA Accepts The Medicines Co.'s NDA

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The Medicines Company (MDCO - Free Report) recently announced the acceptance of its new drug application (NDA) for its antiplatelet candidate, Cangrelor, by the US Food and Drug Administration (FDA). The Medicines Co. is looking to get Cangrelor approved for use in patients undergoing percutaneous coronary intervention (PCI) and in patients requiring bridging from oral antiplatelet therapy to surgery.

The NDA was based on data from several studies including four randomized, double-blind studies (CHAMPION PHOENIX, CHAMPION PLATFORM, CHAMPION PCI, and BRIDGE).

With the FDA accepting the NDA for review, a response should be out in the second quarter of 2014. Meanwhile, the company intends to file for EU approval later this year.

We are pleased with The Medicines Co.’s progress with its pipeline. The company recently presented positive results on its phase III antibiotic candidate, oritavancin. Oritavancin was being evaluated in the phase III SOLO-II study for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant staphylococcus aureus (MRSA).

Earlier, in Dec 2012, the company had presented positive data on oritavancin from another phase III study, SOLO- I. With the SOLO program reporting positive data, The Medicines Co. will file for US and EU approval in the fourth quarter of 2013 and in 2014, respectively.

The Medicines Co. currently carries a Zacks Rank #3 (Hold). At present, companies like Biogen Idec (BIIB - Free Report) , Aeterna Zentaris (AEZS - Free Report) and Protalix BioTherapeutics, Inc. (PLX - Free Report) look well positioned. All three are Zacks Rank #1 (Strong Buy) stocks.

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