IMPAX new drug targets $800 million. restless legs syndrome market

IMPAX LABS : Impax Pharmaceuticals Provides an Update on Pipeline Candidate IPX159

05/10/2011 | Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced the successful filing of an Investigational New Drug Application (IND) for IPX159 in Restless Legs Syndrome (RLS) and initiated a Phase I study. The Company will test multiple formulations of IPX159 in this Phase I study in healthy volunteer subjects. The Company plans to start a Phase IIb study in RLS patients in the fourth quarter of 2011 after selection of a preferred formulation. "We are pleased to announce progress in our neurology pipeline, with the start of the Phase I study of IPX159 and we look forward to continued development of this compound in RLS," said Suneel Gupta, Ph.D., chief scientific officer, Impax Pharmaceuticals.

About IPX159  IPX159 is an oral controlled-release formulation of a small molecule with a unique mechanism of action in RLS. IPX159 is a new molecular entity in the US. The compound has an established pharmacologic and safety profile for non-RLS use outside the US and Impax has completed a proof of concept study in RLS.

About Restless Legs Syndrome  Restless Legs Syndrome (RLS) is a condition characterized by an irresistible urge to move ones' limbs, most commonly the legs, to stop uncomfortable sensations and is associated with sleeping abnormalities, somnolence, pain and discomfort. There are about 25 million RLS sufferers in the US and an estimated current market size of $800 million.

About Impax Laboratories, Inc.  Impax Laboratories, Inc. is a technology-based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.