Having failed so far to get its extended-release Parkinson's drug Rytary to market, Impax Laboratories ($IPXL) is turning to asking three big-name specialists what it should do.
The Hayward, CA drug company said Monday that its board of directors had set up a compliance committee of three independent directors. They will try to steer the company past an FDA warning letter that has stopped the FDA from considering the application for Rytary and cost it its partnership with GlaxoSmithKline ($GSK) over the delays.
The committee is headed by Dr. Leslie Z. Benet, a University of California San Francisco professor, and also includes Dr. Allen Chao and Peter R. Terreri. Benet has served in a number of FDA advisory positions, including the FDA Expert Panel on Individual Bioequivalence and the FDA Center for Biologics Peer Review Committee. Dr. Chao is cofounder of Watson Pharmaceuticals, now Actavis ($ACT), while Terreri is the former chief financial officer of Teva Pharmaceuticals USA and now CEO of CGM, an adhesives and sealant manufacturer.
The move appeared to aim at easing investor worries. Shares of the company closed Monday at $18.43, off 32% from their 12-month high of $27.02 on Oct. 2. It was off another 9 cents in mid-morning trading today.
Impax specializes in extended release formulations, and Rytary is an investigational extended-release capsule formulation of carbidopa-levodopa for the treatment of idiopathic Parkinson's disease. Impax has been struggling for two years to get its manufacturing practices up to par at the plant in California where it intends to produce Rytary. It received a warning letter for the plant in 2011. Impax broke the news to investors in January that the FDA would not consider approval of the drug until it had signed off on the plant. That was after an re-inspection and a 12-page Form 483, which the company said clouded the timeline for the approval process. Impax said then that it still hoped to launch Rytary in 2014.
The re-inspection of the plant, however, was a train wreck; Impax received a Form 483 with a dozen observations, three of them repeats. It was enough for GSK to break ties with Impax earlier this month. That sends Impax back to the street looking for a partner and complicates an already difficult financial situation, CEO Larry Hsu has acknowledged.
- here's the release