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Cubist Pharmaceuticals Inc. (CBST - Analyst Report) 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.

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 non-cancer pain.

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 CDAD.

Our Recommendation

We currently have a Neutral recommendation on Cubist Pharma. The stock carries a Zacks #3 Rank (Hold rating) in the short run.

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