Cubist Pharmaceuticals, Inc. (CBST) 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 2013.
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 cUTI.
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. (ALPMF).
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.Read the Full Research Report on CBST
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