Cubist Pharmaceuticals Inc.
) received some encouraging news recently when the US Food and
Drug Administration (FDA) accepted two of the company's
antibiotic candidates, CXA-201 and CB-315, as qualified
infectious disease products (QIDP) under the Generating
Antibiotic Incentives Now (GAIN) Act.
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We note that Cubist Pharma applied to the FDA for granting QIDP
designation to CXA-201 and CB-315 earlier in the year. The
positive response from the US regulatory body would qualify
CXA-201 and CB-315 for a five-year extension of Hatch-Waxman
exclusivity (on approval), priority review and eligibility for
We note that the GAIN act was signed into law by the US president
in July 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. Companies such as
The Medicines Company
) apart from Cubist Pharma stand to benefit from the signing of
We note that CXA-201 is undergoing late-stage studies for
complicated intra-abdominal infections and complicated urinary
tract infections caused by gram-negative bacterial infections.
The QIDP status granted by the FDA is applicable to CXA-201 being
developed as a therapy for complicated intra-abdominal
infections. CB-315 is undergoing phase III studies for treating
patients suffering from clostridium difficile-associated diarrhea
Apart from CXA-201 and CB-315, CB-5945 is another interesting
late-stage candidate at Cubist Pharma. CB-5945 is being developed
for treating opioid-induced constipation in patients with chronic
We believe that the pipeline at Cubist Pharma has to deliver
since it is currently highly dependent on Cubicin (daptomycin)
for growth. Cubicin is marketed in the US and several other
markets for the treatment of severe bacterial infections of the
skin and bloodstream. Moreover, Entereg, which was added to
Cubist Pharma's portfolio following the acquisition of Adolor
Corporation, is marketed by Cubist Pharma to expedite
gastrointestinal recovery following bowel resection surgery.
Furthermore, Cubist Pharma derives service revenues from its
two-year agreement with Optimer for the co-promotion of Optimer's
Dificid (fidaxomicin) in the US. Dificid is marketed for treating
patients suffering from CDAD.
We currently have a Neutral recommendation on Cubist Pharma. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.