Impax Shares Plummet as FDA Finds Manufacturing Issues

Impax Shares Plummet as FDA Finds Manufacturing Issues

March 6th, 2013 // 1:33 pm @ marquee

Impax Laboratories Inc. (IPXL), the developer of the experimental drug Rytary for Parkinson’s disease, fell the most in almost three years after regulators found that manufacturing issues persist at a company plant.

Impax declined 25 percent to $15.03 at 11:03 a.m. New York time, after falling to $14.88 in the biggest intraday drop since May 2010. The plant in Hayward, California, where the company is based, is barred by the Food and Drug Administration from producing new drugs.

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FDA inspectors found 12 “observations” in their most recent inspection of the facility, including three repeat manufacturing problems that have not corrected since past inspections, Impax said yesterday in a statement. The FDA and Impax have been at odds over the plant since at least 2010, according to government letters to the company.

“We have committed significant resources in our efforts to meet FDA requirements and are clearly disappointed by this news,” Impax Chief Executive Officer Larry Hsu said in the statement. “Resolving the FDA concerns remains a top priority and we intend to complete this work as quickly as possible.”

The FDA required the re-inspection after rejecting Rytary in January. If the drug is approved, Impax will sell Rytary in the U.S. and Taiwan while London-based GlaxoSmithKline Plc, will market it in other regions throughout the world.

Rytary combines standard Parkinson’s medications in a new sustained release formulation, Impax said. The company also has manufacturing facilities in Philadelphia and Taiwan.