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Cubist Pharma Reports Publicant of Pivotal Data from SIVEXTRO ESTABLISH-2 Trial

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Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) today announced that The Lancet
Infectious Diseases published online the positive results from ESTABLISH-2, a
pivotal Phase 3 clinical trial of the investigational antibiotic SIVEXTRO™
(tedizolid phosphate), which is being developed for the treatment of acute
bacterial skin and skin structure infections (ABSSSI) and complicated skin and
soft tissue infections (cSSTI). The results will also appear in a forthcoming
print issue of the journal. The authors note that ESTABLISH-2 was the first
prospectively designed clinical trial consistent with the fundamental elements
outlined in the final U.S. Food and Drug Administration (FDA) ABSSSI Guidance
released in 2013.

SIVEXTRO is a once daily oxazolidinone being developed for both intravenous
(I.V.) and oral administration for the treatment of serious infections caused
by certain Gram-positive bacteria, including those caused by
methicillin-resistant Staphylococcus aureus (MRSA). The published data are
based on one of the two global Phase 3 clinical studies of SIVEXTRO
(ESTABLISH-1 and ESTABLISH-2), which met the primary and secondary endpoints
defined by the FDA and European Medicines Agency (EMA). The clinical trials
enrolled 1,333 people in the U.S., Europe and other regions worldwide.

As outlined in The Lancet Infectious Diseases, a focus of the ESTABLISH-2
clinical trial was to evaluate the efficacy and safety of the I.V. to oral
transition of SIVEXTRO in the treatment of ABSSSI. The randomized, controlled
Phase 3 clinical trial compared SIVEXTRO 200 mg given as a once daily dose for
six days with linezolid 1200 mg divided as a twice daily dose for 10 days,
both administered by I.V. with a possible switch to oral study treatment, when
pre-specified criteria were met. Results showed a six-day course of once-daily
SIVEXTRO to be non-inferior to 10 days of twice-daily linezolid for the
treatment of ABSSSI. In the ESTABLISH-2 study, the adverse event rates were
similar for both SIVEXTRO and linezolid treated patients. Gastrointestinal
adverse events (diarrhea, nausea and vomiting) were the most commonly reported
in both treatment groups.

“Publication of ESTABLISH-2 clinical trial results in The Lancet Infectious
Diseases contributes important information to the infectious disease community
worldwide about SIVEXTRO,” said Steven Gilman, Ph.D., Executive Vice President
of Research and Development and Chief Scientific Officer of Cubist
Pharmaceuticals. “These data provide further support for the potential of
SIVEXTRO as a novel treatment option that might be used in the transition from
I.V. to oral therapy in a short, six-day course of treatment for patients with
serious skin infections.”

“Acute bacterial skin and skin structure infections are a common problem that
we see every day in emergency departments and clinics across the U.S. These
infections can be devastating to patients, and are among the most common
infections treated in hospitals. MRSA is recognized as a frequent cause of
these infections, and is now declared a serious public health threat in the
U.S. because of increasing incidence in the last decade,” said Gregory J.
Moran, M.D., Clinical Professor, UCLA Dept. of Emergency Medicine. “With
limitations of some existing therapies, including resistance to certain
agents, there is a need for new antibiotics in addition to a focus on
appropriate use. It is encouraging to see these clinical trial data in
hospital and outpatient settings, as SIVEXTRO may become a potential treatment
option for acute bacterial skin and skin structure infections, including those
caused by MRSA.”

Data from the ESTABLISH-2 study, along with data from the previously published
ESTABLISH-1 study, served as the basis for Cubist's New Drug Application (NDA)
for SIVEXTRO, for which Cubist is seeking approval in acute bacterial skin and
skin structure infections (ABSSSI). The FDA accepted the NDA in December 2013
for Priority Review, assigning a Prescription Drug User Fee Act (PDUFA) action
date of June 20, 2014. On March 31, 2014 the FDA Anti-Infective Drug Advisory
Committee (AIDAC) voted unanimously to recommend approval of SIVEXTRO. The
Company also recently announced that the EMA accepted for review its Marketing
Authorization Application (MAA) for SIVEXTRO, for which Cubist is seeking
approval for the treatment of complicated skin and soft tissue infections
(cSSTI).

Posted-In: News FDA Press Releases

 

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