Biovail, Valeant Pharmaceuticals, GSK gain FDA recommendation for Epilepsy drug Potiga

Biovail logoImage via Wikipedia

Today saw some good news from the FDA as they recommended the joint venture drug, Potiga, by Valeant Pharmaceuticals and Glaxo SmithKline. Valeant is in merger acquisitions with Biovail that should be completed by the year's end.

U.S. Food and Drug Administration advisory committee voted unanimously 11-0 that clinical studies had provided substantial evidence on the safety and effectiveness of ezogabine to treat epilepsy. The Prescription Drug User Fee Act goal date for the FDA to complete its review of the drug’s application is August 30. The drug will be aimed at patients whose other epilepsy medications failed.

Valeant is working with GlaxoSmithKline to develop the drug, which will have the trade name of Potiga and is also known as retigabine. Valeant is set to receive 50% of Potiga’s sales via its development deal with GlaxoSmithKline.

Potiga “will be a good growth driver in neurology,” Meera Venu, a Morningstar Research analyst, told Reuters. Venu has forecast that Potiga will account for $600 million in annual sales by 2019.

Susan Hall, Head of Neurology Research and Development at Valeant said, “We are pleased with the Advisory Committee’s evaluation of ezogabine(Potiga). There is a significant need for additional anti-epileptic drugs because approximately one-third of patients with epilepsy continue to experience seizures despite treatment.”

On June 21st, 2010 we saw a Biovail takeover of Valeant for a one time premium stock dividend of 16.77 a share and 1.7809 Valeant to Biovail stock offering.
Biovail shareholders will hold on to 50.5 percent of the company with Valeant shareholders getting the remaining 49.5 percent. Bloomberg has highlighted the company's synergies within the merger in this article Valeant, Canada's Biovail to Combine in Stock Deal.

Biovail BVF is currently trading at 22.62 -0.44 -1.91% with the market down today heavily. Valeant VRX is trading at 57.87 -0.78 -1.33% and up 0.10 in after hours trading. Glaxo GSK was down -0.94 a 2.51% loss on 36.46 closing. After hours trading has the stock up +0.12.

News of the Merger can be found here:

Biovail Corporation (BVF), Valeant Pharmaceuticals International (VRX) in $3.2B Reverse Merger; Valeant Shareholders to Get $16.77/Share Special Dividend

News of the FDA finding for Potiga can be found here:

Thumbs Up for Valeant's Potiga Means Victory for Biovail
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