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
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
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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
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.
) are examples of stocks carrying Zacks #2 Rank (Buy) and Zacks
#1 Rank (Strong Buy) respectively, in the pharma space.