Shares of Cubist Pharmaceuticals, Inc. (CBST) climbed more than 4% to $73.15 per share on Mar 31, 2014 following the favorable recommendation of an advisory panel of the Food and Drug Administration (:FDA) on the company’s candidate tedizolid phosphate (proposed brand name: Sivextro), an antibiotic.
The Anti-Infective Drugs Advisory Committee (AIDA) of the FDA unanimously (14-0) recommended the approval of the candidate for the treatment of acute bacterial skin and skin structure infections (:ABSSSI). The advisory panel’s favorable view on the antibiotic was based on encouraging safety and efficacy data from two global phase III studies (ESTABLISH 1 and ESTABLISH 2). Data revealed that Cubist’s candidate was non-inferior to Pfizer’s (PFE) Zyvox requiring less frequent dosing and shorter treatment period. These advantages should enable Cubist’s candidate gain market share on approval.
The candidate, added to Cubist’s pipeline through its acquisition of Trius Therapeutics in Sep 2013, is being developed for both intravenous and oral administration. A final decision from the FDA should be out by Jun 20, 2014. We expect the candidate to gain FDA approval.
Cubist has sought EU approval for the candidate for treating complicated skin and soft tissue infections (cSSTI) indication. A final decision from the European Commission (EC) is expected in the first half of 2015.
Cubist’s antibiotic pipeline also includes ceftolozane/tazobactam (complicated urinary tract and intra-abdominal infections). U.S. approval is expected to be sought by June 30, 2014. Surotomycin is another interesting phase III candidate in the company’s pipeline. It is being developed for treating C. difficile acquired diarrhea (:CDAD). Encouraged by the strong antibiotics pipeline, Cubist believes that it will be able to introduce at least 4 new antibiotics into the market by 2020. The biopharmaceutical company intends to spend approximately $400 million in 2014 alone to develop its antibiotic pipeline.
Cubist carries a Zacks Rank # 3 (Hold). Some better-ranked stocks in the biopharma space include Gilead Sciences (GILD) and Alexion Pharmaceuticals (ALXN). Both these stocks carry a Zacks Rank #1 (Strong Buy).