FDA piles misery onto Impax with 2nd Form 483 in a week

Impax Laboratories ($IPXL) has gone 0 for 2 in an FDA plant inspection double header. After acknowledging last week that the FDA had issues with its plant in Taiwan, the California-based Impax said the FDA has now issued a Form 483 for a just-completed inspection at its Hayward, CA, facility.

The latest setback comes just months after Impax said it was confident enough of its manufacturing to resubmit an application for its investigational drug for Parkinson's, approval of which had been delayed because of the FDA's ongoing concerns. The drugmaker said in an announcement Monday that the Form 483 included 7 "inspectional observations, two of which are designated as repeat observations." It came at the conclusion of a two-week inspection that ended July 31.

Impax CEO Fred Wilkinson

"While the past week has been challenging, I remain enthusiastic about Impax's future and the opportunities ahead of us," CEO Fred Wilkinson said in a statement. Reassuring the markets, he said the company had "the financial resources and balance sheet to create new revenue sources through internal and external development, while pursuing strategic and accretive M&A opportunities."

Last year, the company had to cut 110 positions, many from the plant in Hayward, after problems there led partner GlaxoSmithKline ($GSK) to give up on a $186 million partnership with Impax for Rytary. It also changed CEOs, bringing Wilkinson in to help fix its problems.

Today the company said its first priority is dealing with the issues the FDA uncovered at its plants in Hayward and Taiwan.

Among other problems at Hayward, the FDA said that the company had a lot of pyridostigmine bromide tablets that was out of spec, but after ruling out lab error, the plant did not investigate to determine whether there was a problem with manufacturing and released the lot. It also criticized plant maintenance, noting a sagging ceiling tile, a rusty drain and other problems in a walk-in chamber used for storing products for stability studies. The repeat violations had to do with not determining accuracy and reproducibility of testing methods and not having protections in place to make sure analysts "cannot rewrite or delete analytical data during analyses."

The Hayward plant has been an ongoing problem for Impax. Manufacturing problems resulted in a warning letter in 2011 and then a complete response letter for Rytary, its investigational drug for treating idiopathic Parkinson's disease which was developed in Hayward. Impax promised to fix the problems, but a follow-up inspection found even more issues. In April, the company said it felt confident enough about improvements there to resubmit its application for Rytary, its investigational extended-release capsule formulation of carbidopa and levodopa, which had already been delayed because of the ongoing issues in Hayward.

Just last week, Impax said that the FDA has now found a host of problems at its plant in Taiwan, where it had moved much of its manufacturing as it dealt with the initial problems at Hayward. The 10 observations in a Form 483 for the Taiwan facility related to validation of equipment and testing during the production of Rytary as well as issues with the production of other drugs. Impax said the FDA has yet to let it know what these concerns may mean for its application for Rytary.

Today, Wilkinson said Impax will respond to the new to-do list from the FDA within the required 15 days and that "Addressing these latest observations and advancing our quality improvement initiatives are our top priorities."

- read the announcement
- here's the Form 483 for Hayward