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Cubist Pharma Seeks Label Expansion

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Cubist Pharmaceuticals Inc. announced that it has filed for the approval of its drug Entereg (alvimopan) for an additional indication. To achieve this objective, the biopharmaceutical company submitted a supplemental New Drug Application (sNDA) seeking US Food and Drug Administration (FDA) approval for the drug.

Cubist Pharma is looking to get Entereg approved to expedite gastrointestinal (GI) recovery after a surgery including bowel resection with primary anastomosis, expanded from the current indication in patients in need of operation for colorectal disease..

The regulatory application for label expansion was filed primarily on the basis of the positive results announced by Cubist Pharma from a phase IV study, a post-approval commitment with the FDA, of Entereg in patients undergoing radical cystectomy.

We note that radical cystectomy is a major abdominopelvic surgical procedure. The operation is performed on patients suffering from urinary bladder cancer. One of the most common complications accompanying the disorder is delayed recovery of GI function.

The results from the phase IV study revealed that upper and lower GI recovery was faster in patients treated with Entereg as opposed to those in the placebo arm. Moreover, the mean and median for postoperative hospital stay was 2.6 and 1 days less, respectively, for patients in the Entereg arm compared to those treated with placebo.

Approval of Entereg for the new indication would increase its sales potential significantly. Entereg was added to Cubist Pharma’s product portfolio following the acquisition of Adolor Corporation in 2011.

We currently have a Neutral recommendation on Cubist Pharma. The stock carries a Zacks #3 Rank (Hold) in the short run. Ironwood Pharma (IRWD - Free Report) and Valeant Pharma (VRX - Free Report) are examples of stocks carrying Zacks #2 Rank (Buy) and Zacks #1 Rank (Strong Buy) respectively, in the pharma space.

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