UPDATED: Impax believes manufacturing issues are fixed

Impax Laboratories ($IPXL) had its future sidelined by manufacturing problems that set off a domino effect. The issues kept the FDA from considering its application for its investigational therapy for Parkinson's disease, which led GlaxoSmithKline ($GSK) to walk away from their partnership. It then turned to experts to address the problems and laid off 110 workers. Now, it says it is ready to get back in the game.

The drugmaker announced last week that after talking it over with the FDA, it had resubmitted the NDA for Rytary. The application included updated safety and stability information. The FDA will need to reinspect the Impax manufacturing facilities involved in the production of the drug before it makes a decision.

Its plant in Hayward, CA, is where Impax's problems began. A warning letter in May 2011 found issues, and then last year it got a complete response letter because the drug was developed in Hayward and some of the clinical trial batches were manufactured in Hayward. The company acknowledged that a follow-up inspection of its plant was a train wreck. Impax received a Form 483 with a dozen observations, three of them repeats. It went on for 12 pages, listing problems inspectors had with the testing and handling of levodopa, the API in Rytary, as well as problems with testing of 17 other products made at the plant. The company has continued to manufacture generic drugs at the plant while it has been working out its issues there. 

That was all enough for GSK, which had an $186 million deal to help Impax get the drug to market in exchange for the rights outside of the U.S. Mark Donohue, viice president of investor relations and corporate communications, said in an email that "GSK had marketing rights outside the U.S. and Taiwan. Therefore, they could submit the MMA filing in Europe at anytime.  Also, GSK had an upcoming milestone payment due to Impax." 

After GSK moved on, the Impax board called on three board members, including a former CFO at Teva ($TEVA) and a co-founder of Watson Pharmaceuticals, to help it figure out what to do. That led to the layoffs as it moved some production to an FDA-approved facility in Taiwain and production levels in the Hayward plant were ramped down. 

Now, Impax says it has put its issues behind it, and so it is again seeking Rytary approval. Because the FDA classified it as a Class 2 resubmission for review purposes, Impax said the FDA will decide whether to accept it within 14 days of the submission.

- here's the statement