), which is expecting the FDA to approve its antibiotic candidate
Sivextro today, received encouraging news yesterday on another
pipeline candidate, ceftolozane/tazobactam. The FDA stated that it
will review Cubist's New Drug Application (NDA) for
ceftolozane/tazobactam on a priority basis and assigned a target
date of Dec 21, 2014. We expect the market to react positively to
the news on ceftolozane/tazobactam.
Cubist is looking to get the candidate approved for treating
complicated urinary tract and intra-abdominal infections. We remind
investors that the NDA was submitted by Cubist to the FDA in April
this year. The NDA was submitted on the basis of positive results
from two phase III studies. EU approval of ceftolozane/tazobactam
will be sought in the latter half of the year for the same
indications. We expect the candidate to gain approval.
Sivextro is on the verge of gaining approval with a decision
expected today. We believe that the FDA will render a favorable
decision on Sivextro, making it the third approved antibiotic in
We note that in Mar 2014, the Anti-Infective Drugs Advisory
Committee of the FDA unanimously (14-0) recommended the approval of
the candidate for the treatment of acute bacterial skin and skin
structure infections. 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 the candidate was non-inferior to
) Zyvox, requiring less frequent dosing and a shorter treatment
Furthermore, the candidate is under review in the EU for the
complicated skin and soft tissue infections indication. A final
decision from the European Commission is expected in the first half
The company expects to have four antibiotics
(ceftolozane/tazobactam, Sivextro in addition to the already
approved Cubicin and Dificid) in the market by 2015. The company
intends to spend approximately $400 million in 2014 alone to
develop its antibiotic pipeline. Surotomycin is another 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).
) are better-ranked stocks in the healthcare sector, sporting a
Zacks Rank #1 (Strong Buy).
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