Salix Pharmaceuticals, Ltd. (SLXP) announced that the FDA has granted final approval for Uceris (budesonide, 2 mg) rectal foam for the induction of remission in patients with active mild to moderately distal ulcerative colitis.
The final FDA approval for Uceris came in after the expiration of the 45-day waiting period following the tentative approval granted on Sep 15 as per section 505(c)(3)(C) of the Federal Food, Drug and Cosmetic Act.
The company plans to commence field promotion of the rectal foam in Jan 2015.
Salix had licensed Uceris rectal foam from Germany-based Dr. Falk Pharma. The product is approved in Europe since 2006 and is marketed there by Dr. Falk Pharma.
In several studies, Uceris demonstrated efficacy in treating distal ulcerative colitis. As per data from these studies, Uceris not only improved reach but also resulted in fast distribution of budesonide to the sigmoid colon and the rectum without the problems and inconvenience associated with the retention of enema formulations. Additionally, the rectal foam provides a fast and targeted therapy for distal ulcerative colitis than currently available oral therapies.
Meanwhile, we remind investors that Salix has terminated its merger agreement with Cosmo Technologies Ltd. As per the terms of the termination, Salix will make a $25 million payment to Cosmo.
Currently, Salix appears to be a lucrative acquisition target. Rumors are rife about Allergan Inc. (AGN) looking to acquire Salix in order to deter Valeant Pharmaceuticals’ (VRX) hostile takeover plans (read more: Allergan and Salix Pharmaceuticals Up on Takeover Rumors)
Salix is a Zacks Rank #3 (Hold) stock. A better-ranked stock in the health care sector is Shire (SHPG), a Zacks Rank #1 (Strong Buy) stock.
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