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IMPAX Laboratories, Inc. (IPXL) Asks FDA for Approval of Parkinson's Drug


12/22/2011 7:31:57 AM

San Francisco Business Times by Ron Leuty, Reporter

Impax Laboratories Inc., traditionally a maker of generic drugs, submitted an application for its new treatment for Parkinson’s disease symptoms.

The Hayward company (NASDAQ: IPXL) said Wednesday that its branded products unit made the application for IPX-066 to the Food and Drug Administration.

IPX-066, an extended-release capsule formulation of carbidopa-levodopa, is being developed in collaboration with GlaxoSmithKline (NYSE: GSK) for use outside the United States and Taiwan.

If the drug is approved by the FDA, Impax would commercialize it in the United States with its own neurology sales force.

IPX-066 is meant to control jerky movements by patients with the neurodegenerative disorder by keeping levodopa in the blood longer and with more consistency than current treatments.

Impax said the drug has been studied in about 900 Parkinson’s patients.

“In just three and a half years, Impax’s brand research and development team has successfully advanced IPX-066 from an investigational new drug through multiple clinical studies of efficacy and safety, culminating in our NDA submission,” Michael Nestor, president of the Impax Pharmaceuticals unit, said in a press release.

IPX-066 has been studied in about 900 Parkinson’s disease patients.




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