Cubist Rises on Positive Data - Analyst Blog

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Shares of Cubist Pharmaceuticals, Inc. ( CBST ) jumped over 5.9% with the company announcing encouraging top-line results from a phase III study on ceftolozane/tazobactam being developed for the treatment of complicated intra-abdominal infections (cIAI).

Data showed that ceftolozane/tazobactam plus metronidazole was statistically non-inferior to AstraZeneca 's ( AZN ) Merrem (meropenem). Results met the non-inferiority margin and the lower and upper bounds of the confidence interval defined by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

However, the treatment emergent adverse event rate in patients treated with ceftolozane/tazobactam plus metronidazole was more than those under Merrem.

These results come shortly after Cubist Pharma announced positive top-line data from another phase III study on ceftolozane/tazobactam in combination with Johnson & Johnson 's ( JNJ ) Levaquin (levofloxacin) in adults suffering from complicated urinary tract infections (cUTI).

Top-line results from the study revealed that ceftolozane/tazobactam was non-inferior to Levaquin in treating cUTI, thus meeting the primary endpoint of the trial. In fact, data suggested statistical superiority of ceftolozane/tazobactam over the Johnson & Johnson antibiotic in treating the disease.

On the back of positive results from these two studies, Cubist Pharma now plans to submit a New Drug Application (NDA) for ceftolozane/tazobactam to the FDA in the first half of 2014 for both indications. Cubist Pharma also intends to do the same in the EU in the latter half of next year.

We note that ceftolozane/tazobactam is also being developed for the treatment of hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP). Cubist Pharma intends to begin a phase III study to evaluate the safety and efficacy of the candidate in this indication in the first half of 2014.

We are encouraged by the company's progress with ceftolozane/tazobactam so far. Cubist Pharma's antibiotic portfolio already has Cubicin, approved for the treatment of complicated skin and skin structure infections. Moreover, the company acquired a couple of companies earlier in the year to expand its antibiotic portfolio further.

Cubist Pharma, a biopharmaceutical company, currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma space include Actelion Ltd. ( ALIOF ). Actelion holds 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: ALIOF , AZN , CBST , JNJ

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