Impax Provides Update On Meeting With FDA To Review Phase III Trial Results For IPX056

December 11, 2008

HAYWARD, Calif. (December 11, 2008) – IMPAX Laboratories, Inc. today announced that it met with representatives of the U.S. Food and Drug Administration (FDA) to review the results of its IPX056 clinical development program and discuss next steps in development leading to submission of a new drug application (NDA).; IPX056 is an investigational extended-release formulation of baclofen, the drug of choice in the treatment of spasticity, which has the potential to offer improved control of symptoms and dosing convenience.

As previously announced, IPX056 met its clinical endpoints in a Phase III study of spasticity in multiple sclerosis patients.;The randomized, placebo and active comparator-controlled double blind Phase III study enrolled 173 MS patients and included a seven-week open label extension. The primary efficacy endpoint, a reduction in spasticity as measured by Ashworth score following a single dose, was statistically significant for all active treatments, including IPX056 formulations and baclofen, compared to placebo.Results from the open label extension suggest that IPX056 reduced morning stiffness and nighttime awakenings as compared to conventional baclofen in these patients.; IPX056 was generally safe and well tolerated in the study

In the meeting with the FDA, the Company was requested to collect additional longer-term controlled clinical data on the safety and efficacy of IPX056.

Michael Nestor, president of the Impax Pharmaceuticals division of Impax Laboratories said, “While we are pleased with the results of our Phase III trial, we are disappointed that the FDA has increased its expectation for extended use data since our last meeting with the agency in August 2006. We are currently designing a trial, which the agency has agreed to review as a Special Protocol Assessment (SPA), to collect the data requested by the FDA. We expect to initiate the trial in the second half of next year.”

The company is also evaluating the potential need to conduct a pediatric study under the Pediatric Research Equity Act (PREA) which was not invoked at the IPX056 End of Phase II meeting in August 2006. The issue of a pediatric study was first raised by FDA at the most recent meeting. The Company will hold further discussions with the agency on this subject.

“The Phase III results were positive and we gained valuable experience with the effectiveness of IPX056 in reducing symptoms of spasticity in patients with MS.Furthermore, we have insight into some aspects of the product where we believe IPX056 could offer improved control of spasticity symptoms in these patients” said Larry Hsu, Ph.D., president and chief executive officer of IMPAX Laboratories.

The IMPAX Pharmaceuticals division of IMPAX Laboratories currently has two products in its development pipeline, directed to neurology as a therapeutic focus, with four other central nervous system (CNS) specific products undergoing feasibility assessment. The Company filed an Investigational New Drug application for IPX066, a controlled-release formulation of Carbidopa/Levodopa in July 2008, and expects to initiate a study in Parkinson’s disease patients by the end of this year with completion expected in the second quarter of 2009.

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 brand products. IMPAX markets its generic products through its Global Pharmaceuticals division and will market its brand products through the IMPAX Pharmaceuticals division. Additionally, where strategically appropriate, IMPAX has developed marketing partnerships to fully leverage its technology platform. IMPAX Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward and Philadelphia facilities. For more information, please visit the Company's Web site at:

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