Cubist Pharmaceuticals, Inc.
) recently received encouraging news when the US Food and Drug
Administration (FDA) granted the company's antibiotic candidate
ceftolozane/tazobactam (CXA-201) a fast track status in Qualified
Infectious Disease Product (QIDP) indications, under the
Generating Antibiotic Incentives Now (GAIN) Act.
The FDA granted the fast track status to CXA-201 for the
Hospital-Acquired Bacterial Pneumonia
(HABP)/Ventilator-Associated Bacterial Pneumonia (VABP) and
Complicated Urinary Tract Infections (cUTI) indications. The US
regulatory body had granted fast track status to CXA-201 for
treating complicated intra-abdominal infections (cIAI) in Feb
With the FDA granting CXA-201 QIDP status for the above
indications, the antibiotic qualifies for multiple benefits
including a 5-year extension of Hatch-Waxman exclusivity (on
approval) and priority review.
We note that the GAIN act was signed into law by the US
president in Jul 2012 as part of the FDA Safety and Innovation
Act (FDASIA). The signing of the GAIN Act should benefit
companies pursuing the development of novel antibiotics.
We remind investors that in Feb 2013, Cubist Pharma was
granted a fast track status for CXA-201 in Complicated
Intra-Abdominal Infections (cIAI).
Cubist Pharma is developing CXA-201 as a potential therapy for
the treatment of serious bacterial infections in the hospitals.
The company is evaluating CXA-201, currently in phase III, as a
potential intravenous therapy for the treatment of cIAI and
Ceftolozane (CXA-101), the key component of CXA-201, was added
to Cubist Pharma's pipeline following its acquisition of Calixa
Therapeutics, Inc. in 2009. Calixa had licensed ceftolozane from
the Japanese company
Astellas Pharma Inc
Cubist Pharma inked a deal with Astellas Pharma in Mar 2013 to
acquire the rights of ceftolozane from the latter for territories
such as Asia-Pacific and Middle East countries which were under
Astellas Pharma as per the original agreement. Cubist Pharma now
has global rights for CXA-201.
Cubist Pharma intends to evaluate the candidate in a phase III
study for treating patients suffering from VABP. The study is
expected to commence in mid-2013.
Cubist Pharma currently carries a Zacks Rank #2 (Buy). Other
Zacks #2 Ranked stocks include
Onyx Pharmaceuticals, Inc.
(Cayman) Inc. (
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