The European Medicines Agency (EMA.TO) accepted Cubist Pharmaceuticals, Inc.’s (CBST) Marketing Authorization Application (MAA) for its investigational antibiotic, ceftolozane/tazobactam. Cubist Pharma is looking to get the candidate approved for treating complicated urinary tract and intra-abdominal infections.
A final decision from the European Commission on the approval of the antibiotic candidate should be out in the second half of 2015. Ceftolozane/tazobactam is also under review in the U.S. with a final decision expected by Dec 21, 2014. The candidate is being reviewed under a priority basis in the U.S.
Ceftolozane/tazobactam is also being studied for other indications like hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. We note that ceftolozane/tazobactam was designated as a qualified infectious disease product (:QIDP) for both the indications, under the Generating Antibiotic Incentives Now (GAIN) Act in the U.S. With the FDA granting ceftolozane/tazobactam QIDP status for the above indications, the antibiotic enjoys multiple benefits including a 5-year extension of Hatch-Waxman exclusivity (on approval).
We are encouraged by Cubist Pharma’s progress with its antibiotic portfolio. With the approval of Sivextro in Jun 2014, the company now has three antibiotic products in its portfolio, the other two being Cubicin and Dificid. Cubicin is Cubist Pharma’s lead product, accounting for more than 91% of its total revenues last year.
The company also has surotomycin in its pipeline, which is being evaluated for the treatment of clostridium difficile-associated diarrhea. Cubist Pharma intends to spend approximately $400 million on antibacterial research and development in 2014. Approval of other antibiotic candidates will strengthen the company’s position in the antibiotic market further.
Cubist Pharma currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the healthcare space include Gilead Sciences Inc. (GILD), Amgen Inc. (AMGN) and Achillion Pharmaceuticals, Inc. (ACHN). While Gilead and Amgen sport a Zacks Rank #1 (Strong Buy), Achillion holds a Zacks Rank #2 (Buy).
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