Impax gives it another go with a once-rejected Parkinson's drug

After a manufacturing problem irked the FDA and scared off partner GlaxoSmithKline ($GSK), Impax Laboratories ($IPXL) is resubmitting its investigational therapy for Parkinson's disease, hoping it can clear an agency inspection and finally get its treatment on the market.

Impax's drug, to be marketed as Rytary, is an extended-release combination of carbidopa and levodopa that helped stymie Parkinson's symptoms in three late-stage trials. In its 2013 rejection of the pill, the FDA took no issue with Rytary's efficacy but denied Impax's application over some manufacturing issues at a California plant. Now, the biotech believes it has remedied the problem and is prepared for an inspection of its facilities and a re-examination of its drug.

But things have changed in the year since Rytary's first FDA roadblock.

GlaxoSmithKline, the Big Pharma partner that promised to help usher the drug onto the market, backed out of its deal with Impax in April, nixing an agreement that could have netted up to $186 million for the Hayward, CA, company. GSK held ex-U.S. marketing rights to Rytary but walked away over "delays in the anticipated regulatory approval and launch dates," Impax said at the time.

The ensuing fallout led Impax to cut about 110 jobs, including that of CEO Larry Hsu, who plans to step down once the company can find a suitable replacement.

Now the company is planning to head back to the partnering table with the goal of finding a collaborator willing to bet that its regulatory woes are a thing of the past.

- read the statement