) moved a step closer towards achieving its objective of having
four antibiotics in the market by 2015 when the FDA approved
Sivextro (200 mg: once daily for six days). Sivextro, cleared by
the FDA for treating adults suffering from acute bacterial skin and
skin structure infections (ABSSSI), becomes the third approved
antibiotic in Cubist's portfolio, after Cubicin and Dificid. We
expect the market to react positively to the news.
The FDA has approved both intravenous as well as oral versions of
the drug which can be used for treating serious skin infections,
including those caused by methicillin-resistant staphylococcus
aureus (MRSA). The favorable decision was based on encouraging
safety and efficacy data from two global phase III studies
(ESTABLISH 1 and ESTABLISH 2). Data revealed that Sivextro was
) Zyvox, requiring less frequent dosing and a shorter treatment
The FDA's decision does not surprise us as, in Mar 2014, the
Anti-Infective Drugs Advisory Committee of the FDA unanimously
(14-0) recommended the approval of the drug for the ABSSSI
Cubist has sought EU approval for Sivextro for treating complicated
skin and soft tissue infections (cSSTI). A final decision from the
European Commission is expected in the first half of 2015.
We note that Sivextro is the second antibiotic to be approved by
the FDA within a month for treating similar skin infections. Late
last month, the U.S. regulatory body cleared
) DALVANCE (dalbavancin) for treating adults suffering from ABSSSI
caused by susceptible gram-positive bacteria, including MRSA. The
disease poses a serious threat to public health according to the
U.S. Centers for Disease Control and Prevention.
Another Cubist antibiotic expected to gain FDA approval by year end
is ceftolozane/tazobactam. A decision on the candidate, currently
under priority review in the U.S., is expected by Dec 21, 2014.
Cubist is looking to get the candidate approved for treating
complicated urinary tract and intra-abdominal infections.
Cubist intends to spend approximately $400 million in 2014 alone to
develop its antibiotic pipeline. Surotomycin is an 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).
) is a better-ranked stocks in the healthcare sector, sporting a
Zacks Rank #1 (Strong Buy).
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