Valeant Pharmaceuticals International, the Aliso Viejo-based drug maker, said Wednesday that ezogabine, a drug it’s developing to treat epilepsy, got a regulatory nod.
A Food and Drug Administration advisory panel voted 11-0 with two abstentions that monitoring patients who take ezogabine would help minimize side effects.
The panel wasn’t asked to vote on whether to recommend approval of ezogabine, which is aimed at controlling seizures in epileptic patients when other medicines fail.
A final regulatory decision on the drug is due by Aug. 30. The FDA usually follows the recommendations of its panels.
Valeant is working with British drug maker GlaxoSmithKline PLC 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.
Separately, Valeant said it and Canada’s Biovail Corp. set a Sept. 27 date for shareholders to vote on Biovail’s pending $3.2 billion buy of Valeant. Valeant will hold a voting meeting in Madison, N.J.
Valeant and Biovail said that both companies’ boards already have approved the deal, which is set to close by the end of 2010.
After the deal’s complete, the new company, which is going to retain the Valeant name and Chief Executive J. Michael Pearson, will move its corporate headquarters from Aliso Viejo to Canada.
