Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that IPX066 APEX-PD Phase III clinical study data will be presented in a Late Breaker Session at the 63rd annual meeting of the American Academy of Neurology Conference in Honolulu, Hawaii, held from April 9 to April 16. IPX066 is an investigational extended release carbidopa-levodopa (CD-LD) product intended to treat the motor symptoms of Parkinson's disease.

On November 18, 2010, the Company reported positive top-line results of the APEX-PD trial. The results demonstrated the safety and efficacy of IPX066 in patients with early PD. The study met its primary efficacy endpoint of change from baseline in the sum of United Parkinson's Disease Rating Scale (UPDRS) Parts II and III score at end of study. The study also met several secondary endpoints including, Clinician Global Impression of change and Patient Global Impression of change. There were no unexpected drug-related serious adverse events observed in IPX066 treated subjects.

The Late-Breaker oral presentation of IPX066 APEX-PD results is as follows:

Date and Time:
April 13, 2011 at 5:00 PM (local time)

Presentation Title and Number:
Double-Blind, Placebo-Controlled Fixed-Dose Trial of IPX066, a Novel Carbidopa-Levodopa (CD-LD) Extended-Release Formulation, in Early Parkinson's Disease (APEX-PD Trial); LBS.001

Presenter:
Rajesh Pahwa, MD, Professor of Neurology, University of Kansas Medical Center

About the APEX-PD Study

The APEX-PD study was a randomized, double-blind, placebo controlled, parallel group, fixed-dose study comparing 3 doses of IPX066 to placebo in patients with early Parkinson's disease. The study was conducted under a Special Protocol Assessment agreement with the US Food and Drug Administration (FDA) and is part of the IPX066 clinical development plan agreed with the FDA and the European Medicines Agency.

About IPX066

IPX066 is an investigational CD-LD product with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer reliable control of PD motor symptoms, such as the reduction in "off time" throughout the day, which has been observed in preliminary studies of IPX066.

About Our Collaboration with GlaxoSmithKline (GSK)

Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066, outside the United States and Taiwan, in December 2010. Under the terms of the agreement, GSK received an exclusive license to sell IPX066 throughout the world except in the U.S. and Taiwan. Impax will complete the current Phase III program for IPX066, which includes the ADVANCE-PD study.

About Parkinson's Disease

Parkinson's Disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.

Source:
Impax Laboratories, Inc.