Cubist Gains FDA Approval for Sivextro - Analyst Blog


Cubist Pharmaceuticals ( CBST ) moved a step closer towards achieving its objective of having four antibiotics in the market by 2015 when the FDA approved Sivextro (200 mg: once daily for six days). Sivextro, cleared by the FDA for treating adults suffering from acute bacterial skin and skin structure infections (ABSSSI), becomes the third approved antibiotic in Cubist's portfolio, after Cubicin and Dificid. We expect the market to react positively to the news.  

The FDA has approved both intravenous as well as oral versions of the drug which can be used for treating serious skin infections, including those caused by methicillin-resistant staphylococcus aureus (MRSA). The favorable decision was based on encouraging safety and efficacy data from two global phase III studies (ESTABLISH 1 and ESTABLISH 2). Data revealed that Sivextro was non-inferior to Pfizer 's ( PFE ) Zyvox, requiring less frequent dosing and a shorter treatment period.

The FDA's decision does not surprise us as, in Mar 2014, the Anti-Infective Drugs Advisory Committee of the FDA unanimously (14-0) recommended the approval of the drug for the ABSSSI indication.

Cubist has sought EU approval for Sivextro for treating complicated skin and soft tissue infections (cSSTI). A final decision from the European Commission is expected in the first half of 2015.

We note that Sivextro is the second antibiotic to be approved by the FDA within a month for treating similar skin infections. Late last month, the U.S. regulatory body cleared Durata Therapeutics ' ( DRTX ) DALVANCE (dalbavancin) for treating adults suffering from ABSSSI caused by susceptible gram-positive bacteria, including MRSA. The disease poses a serious threat to public health according to the U.S. Centers for Disease Control and Prevention.

Another Cubist antibiotic expected to gain FDA approval by year end is ceftolozane/tazobactam. A decision on the candidate, currently under priority review in the U.S., is expected by Dec 21, 2014. Cubist is looking to get the candidate approved for treating complicated urinary tract and intra-abdominal infections.

Cubist intends to spend approximately $400 million in 2014 alone to develop its antibiotic pipeline. Surotomycin is an interesting phase III candidate in the company's pipeline. It is being developed for treating C. difficile acquired diarrhea. We expect investor focus to remain on updates regarding Cubist's antibiotic portfolio going forward.

Cubist carries a Zacks Rank #3 (Hold). Gilead Sciences ( GILD ) is a better-ranked stocks in the healthcare sector, sporting a Zacks Rank #1 (Strong Buy).

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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 The NASDAQ OMX Group, Inc.

This article appears in: Investing , Business , Stocks

Referenced Stocks: PFE , GILD , CBST , DRTX

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