Cubist Pharmaceuticals (CBST) possesses an interesting antibiotics product portfolio/pipeline. The company’s primary growth engine is the antibiotic Cubicin. The other marketed antibiotic at Cubist is Dificid. The company has two antibiotics under regulatory review - ceftolozane/tazobactam and Sivextro. Cubist believes that it will have 4 antibiotics in the market by 2015. The company intends to spend approximately $400 million in 2014 alone to develop its antibiotic pipeline.
Sivextro (tedizolid phosphate) was added to Cubist’s pipeline following its acquisition of Trius Therapeutics last year. The candidate is under priority review by the FDA for treating acute bacterial skin and skin structure infections (:ABSSSI).
In Mar 2014, the Anti-Infective Drugs Advisory Committee (AIDA) of the FDA unanimously (14-0) recommended the approval of the candidate for the treatment of 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).
A final decision from the FDA is expected on Jun 20, 2014. Cubist has sought EU approval for the candidate for treating complicated skin and soft tissue infections (cSSTI). A final decision from the European Commission is expected in the first half of 2015.
Late last week, Cubist announced the online publication of the ESTABLISH 2 study results in the journal titled The Lancet Infectious Diseases. Data revealed that the candidate (dosed once daily over a 6-day treatment period) was non-inferior to Pfizer’s (PFE) Zyvox (linezolid: dosed twice a day for 10 days).
Cubist’s antibiotic pipeline also includes ceftolozane/tazobactam (complicated urinary tract and intra-abdominal infections). While U.S. approval for the above indications has been sought by the company, EU approval will be sought in the latter half of the year. Furthermore, Cubist intends to initiate a phase III study on ceftolozane/tazobactam in patients suffering from hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia by Jun 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). We expect investor focus to remain on updates regarding Cubist’s antibiotics pipeline going forward.
Cubist carries a Zacks Rank #3 (Hold). Gilead Sciences (GILD) and Regeneron Pharmaceuticals (REGN) are examples of better-ranked stocks in the healthcare sector sporting a Zacks Rank #1 (Strong Buy).