Cubist Pharmaceuticals, Inc.
) jumped over 5.9% with the company announcing encouraging
top-line results from a phase III study on ceftolozane/tazobactam
being developed for the treatment of complicated intra-abdominal
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Data showed that ceftolozane/tazobactam plus metronidazole was
statistically non-inferior to
) Merrem (meropenem). Results met the non-inferiority margin and
the lower and upper bounds of the confidence interval defined by
both the U.S. Food and Drug Administration (FDA) and the European
Medicines Agency (EMA).
However, the treatment emergent adverse event rate in patients
treated with ceftolozane/tazobactam plus metronidazole was more
than those under Merrem.
These results come shortly after Cubist Pharma announced positive
top-line data from another phase III study on
ceftolozane/tazobactam in combination with
Johnson & Johnson
) Levaquin (levofloxacin) in adults suffering from complicated
urinary tract infections (cUTI).
Top-line results from the study revealed that
ceftolozane/tazobactam was non-inferior to Levaquin in treating
cUTI, thus meeting the primary endpoint of the trial. In fact,
data suggested statistical superiority of ceftolozane/tazobactam
over the Johnson & Johnson antibiotic in treating the
On the back of positive results from these two studies, Cubist
Pharma now plans to submit a New Drug Application (NDA) for
ceftolozane/tazobactam to the FDA in the first half of 2014 for
both indications. Cubist Pharma also intends to do the same in
the EU in the latter half of next year.
We note that ceftolozane/tazobactam is also being developed for
the treatment of hospital-acquired bacterial pneumonia
(HABP)/ventilator-associated bacterial pneumonia (VABP). Cubist
Pharma intends to begin a phase III study to evaluate the safety
and efficacy of the candidate in this indication in the first
half of 2014.
We are encouraged by the company's progress with
ceftolozane/tazobactam so far. Cubist Pharma's antibiotic
portfolio already has Cubicin, approved for the treatment of
complicated skin and skin structure infections. Moreover, the
company acquired a couple of companies earlier in the year to
expand its antibiotic portfolio further.
Cubist Pharma, a biopharmaceutical company, currently carries a
Zacks Rank #3 (Hold). Some better-ranked stocks in the biopharma
). Actelion holds a Zacks Rank #1 (Strong Buy).