IPXL Impax Laboratories, Inc. (delisted)

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that IPX066 ADVANCE-PD and APEX-PD Phase III clinical study data will be presented in Poster Sessions at the 15th International Congress of Parkinson’s Disease and Movement Disorders Conference in Toronto, Canada, held from June 5 to June 9. IPX066 is an investigational extended release carbidopa-levodopa (CD-LD) product intended to treat the motor symptoms of Parkinson’s disease.

The Poster Sessions of IPX066 ADVANCE-PD and APEX-PD results are as follows:

 

ADVANCE-PD Presentation

Title: Double-blind, Controlled Trial of IPX066, a Novel Carbidopa-Levodopa Extended-Release Formulation, in Advanced Parkinson’s Disease (ADVANCE-PD Trial)   June 8, 2011 Time: 1:30 p.m. to 3:00 p.m. Location: South Building, Level 800, Hall E Abstract Number: LB9 Presenter: Robert A. Hauser, MD, Professor of Neurology, Molecular Pharmacology, and Physiology and Director of the Parkinson's Disease & Movement Disorders Center at the University of South Florida  

APEX-PD Presentation

Title: Efficacy and safety of IPX066, a New Carbidopa-Levodopa (CD-LD) Extended-Release Formulation, in LD-Naïve Early Parkinson’s Disease (APEX-PD Trial)   June 7, 2011 Session Title: Poster Session II Time: 9:00 a.m. to 6:00 p.m., authors present from 1:30 p.m. to 3:00 p.m. Location: South Building, Level 800, Hall E Abstract Number: 407 Presenter: Rajesh Pahwa, MD, Professor of Neurology, University of Kansas Medical Center   June 9, 2011 Tour Title: Guided Poster Tour 13 Parkinson’s disease: Clinical trials Time: 1:30 p.m. to 3:00 p.m. Location: South Building, Level 800, Room 808 Presenter: Rajesh Pahwa, MD, Professor of Neurology, University of Kansas Medical Center  

About the ADVANCE-PD Study

The ADVANCE-PD study is a randomized, double-blind, active-control, parallel-group Phase III study of the safety and efficacy of IPX066 versus IR CD-LD in advanced PD patients with motor fluctuations. The trial enrolled 471 subjects in North America and Europe of which 393 subjects were randomized to participate in the 13-week comparison of IPX066 versus IR CD-LD. Prior to randomization, subjects on a stable IR CD-LD dose regimen entered a 3-week dose-adjustment period for IR CD-LD, followed by a 6-week dose-conversion period to IPX066.

The ADVANCE-PD results demonstrated that IPX066 produced significantly improved control of motor symptoms as compared to IR CD-LD in multiple clinical measures in subjects with advanced PD. IPX066 treatment resulted in a 37% improvement from baseline for IPX066 vs. a 17% improvement from baseline for IR CD-LD (p