Impax now faces FDA issues at Taiwan plant that could affect Rytary

The bad news just keeps piling up for Impax Laboratories ($IPXL) and Rytary, its investigational drug for treating idiopathic Parkinson's disease. After a series of manufacturing ills at its California plant cost it its partnership with GlaxoSmithKline ($GSK), the drug developer reports that its fallback facility in Taiwan has also been found lacking by the FDA. This comes only three months after it said it was resubmitting its application for the extended-release capsule formulation of carbidopa and levodopa, which had been sidelined by problems at the plant in California.

The company today acknowledged that the FDA last week completed an inspection of the plant in Taiwan and laid out 10 observations in a Form 483 that Impax filed as part of an SEC disclosure. The facility was approved by the FDA 5 years ago and manufactures a dozen drugs but the agency had issues with Impax's manufacturing practices this time around. There were observations about the 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 application for Rytary, its investigational extended-release capsule formulation of carbidopa and levodopa.

Among other observations, FDA inspectors noted Impax had not reported issues it had with blending some lots of pyrodostigmine bromide 60-mg tablets, a drug for treating Gravis disease. It also faulted Impax for not quickly investigating the supplier of some raw material that was suspected of being the source of metal found in fenofibrate 200-mg capsules used to treat high cholesterol and triglycerides. There were also questions about sterility testing for Rytary and other drugs.

Impax CEO Fred Wilkinson

Impax CEO Fred Wilkinson said in a statement today that Impax was working with the FDA to understand and deal with the issues. "We remain committed to our overarching goal of implementing a world class continuous quality improvement program and maintaining the highest quality standards across our facilities," said Wilkinson, who was brought in to help the company get its issues with the FDA resolved.

But achieving quality has been an elusive goal for Impax. Manufacturing problems at its Hayward, CA, plant resulted in a warning letter in 2011 and then a complete response letter for Rytary, which was developed in Hayward. Impax promised to fix the problems but a follow-up inspection found even more issues. This time it got a 12-page Form 483 with a dozen observations outlining problems with the testing and handling of levodopa, as well as problems with testing of 17 other products made at the plant.

That was enough for GSK, which withdrew from its $186 million deal to help Impax get the drug to market in exchange for the rights outside of the U.S. After GSK moved on, Impax was short of cash and had to lay off 110 employees. It also moved some production to the Taiwan facility, which also was approved for production of Rytary.

Shares of Impax, which traded as high as $30.74 on July 1, were off more than 15% in mid-morning trading, down to about $24.

- read the announcement
- here's the Form 483