Problems with manufacturing at Impax Laboratories ($IPXL) have turned the company's situation from bad to worse. The issues have stymied movement on its application for a new Parkinson's drug and killed its partnership with GlaxoSmithKline ($GSK). So now the Hayward, CA, manufacturer is bringing in the big guns to help it accomplish what it has been unable to do on its own.
In a move that appeared to aim at easing investor worries, Impax said Monday that its board of directors had set up a compliance committee of three independent directors. The specialists will advise it on "all activities" tied to the FDA at the Hayward manufacturing site, including getting approval of Rytary, its extended-release Parkinson's drug. The group also is overseeing an Impax quality improvement program aimed at getting on top of the Form 483 concerns outlined in a March warning letter.
The triumvirate is comprised of Dr. Leslie Z. Benet, Dr. Allen Chao and Peter R. Terreri. Benet, who chairs the committee, is a University of California San Francisco professor who 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 co-founder 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.
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. 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 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.
Shares of the company closed Monday at $18.43, off 32% from its 12-month high of $27.02 on Oct. 2.
- here's the release
Impax handed 12-page 483 at reevaluation
Manufacturing issues trip up approval for Gilead, Impax
Plant problems stymie Impax NDA, FDA
FDA inspectors cite problems at Impax California plant
Impax reveals warning letter related to drug recall