Cubist Pharmaceuticals Inc.
) recently announced the commencement of a phase III study
(n~1,400) regarding its pipeline candidate CB-5945. The long-term
safety study, which is a part of the phase III CB-5945 program
(n~3,200), is designed to evaluate CB-5945 (0.25 mg twice daily)
for treating opioid-induced constipation (OIC) in patients with
chronic non-cancer pain.
The multicenter, randomized, double-blind, placebo-controlled
phase III study is one of the four registrational studies in
patients suffering from chronic non-cancer pain. The primary
objective of the study is to examine the safety of the candidate
versus placebo over a treatment period of 52 weeks.
Moreover, the study is also designed to evaluate the effects
of CB-5945 on the quality of life. The other three studies of the
program, which would evaluate the efficacy of the candidate, are
expected to commence in the first half of 2013.
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If CB-5945, which became a part of Cubist Pharma's pipeline
following the December 2011 acquisition of Adolor Corporation,
manages to clear the regulatory hurdles and hit the markets, then
it would be highly welcomed by patients since currently there are
no approved therapies for treating OIC in patients with chronic
Apart from CB-5945, the notable late-stage candidates at Cubist
Pharma include CXA-201 (complicated intra-abdominal infections
and complicated urinary tract infections) and CB-315 (C.
difficile acquired diarrhea or CDAD). We are pleased with the
company's focus on developing its pipeline.
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 Pharmaceuticals Inc.
) for the co-promotion of Optimer's Dificid (fidaxomicin) in the
US. Dificid is marketed for treating patients suffering from
We currently have a Neutral recommendation on Cubist Pharma. The
stock carries a Zacks #3 Rank (Hold rating) in the short run.