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Regulatory Update on Cubist Pharma's Tedizolid

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Regulatory decisions on pipeline candidates play an important role for investors in the pharma/biotech sector in deciding whether or not to invest in a particular company. The companies in the above mentioned sector spend a significant amount in advancing their pipelines with an ultimate goal of receiving marketing approvals.

Last week, the European Medicines Agency (:EMA) accepted the Marketing Authorisation Application (MAA) for Cubist Pharmaceuticals, Inc.’s (CBST) antibiotic candidate, tedizolid phosphate. Cubist is looking to get tedizolid phosphate approved for the treatment of complicated skin and soft tissue infections (cSSTI).

The candidate, which came to be a part of Cubist Pharma’s pipeline following its acquisition of Trius Therapeutics in Sep 2013, is being developed for both intravenous and oral administration. A final decision from the European Commission (EC) on the approval of tedizolid phosphate is expected in the first half of next year.

The MAA submission of tedizolid phosphate was on the basis of encouraging data from two phase III studies on the candidate for the indication. Cubist Pharma is also looking to get the candidate approved in the U.S. and Canada. While the company has already sought for U.S. approval, it intends to do the same in Canada by Jun 30, 2014. The company is looking to get tedizolid phosphate approved in the U.S. and Canada for the treatment of acute bacterial skin and skin structure infections (:ABSSSI).

In Dec 2013, the U.S. Food and Drug Administration (:FDA) granted a priority review status to tedizolid phosphate for the ABSSSI indication. A final decision on the approval of the candidate in the U.S. is expected by Jun 20, 2014.

We note that tedizolid phosphate gained eligibility for priority review following its qualified infectious disease product (:QIDP) designation granted by the FDA for the ABSSSI indication last year. The QIDP designation is a part of the Generating Antibiotic Incentives Now (GAIN) Act, which falls under the 2012 FDA Safety and Innovation Act (:FDASIA). Tedizolid phosphate will also be eligible for the FDA's "fast track" status and will enjoy an additional five years of exclusivity once approved. Companies like Forest Laboratories, Inc. (FRX) have also benefited from the signing of the GAIN act.

Cubist Pharma, a biopharmaceutical company, carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space include Alexion Pharmaceuticals, Inc. (ALXN) and Alkermes (ALKS). Both Alexion and Alkermes carry a Zacks Rank #1 (Strong Buy).

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