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<0.0001). “Off time” is the functional state when patients’ medication effect has worn off and there is a return of Parkinson’s symptoms. Additional clinical and patient-reported outcome measures in the study consistently demonstrate the improved IPX066 efficacy profile when compared to IR CD-LD. IPX066 was generally well tolerated, and during the double-blind portion of the trial had an adverse event (AE) rate of 43% compared to 40% for IR CD-LD. The most common AEs reported for IPX066 included: insomnia, nausea, fall, dizziness, and dyskinesia (no event was associated with a greater than 3.5% overall incidence).

About the APEX-PD Study

The APEX-PD study is a randomized, double-blind, placebo controlled, parallel group, fixed-dose study comparing three doses of IPX066 to placebo in patients with early Parkinson’s disease. The trial enrolled 381 subjects in North America and Europe who were randomized to receive one of three doses of IPX066 or matching placebo administered orally three times per day for 30 weeks. 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.

The APEX-PD 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 most commonly reported adverse events in the IPX066 treatment arms included nausea, headache, and dizziness which are consistent with carbidopa-levodopa products.

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 register and commercialize 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.

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.

" Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

To the extent any statements made in this news release contain information that is not historical, these statements are forward-looking in nature and express the beliefs and expectations of management. Such statements are based on current expectations and involve a number of known and unknown risks and uncertainties that could cause the Company’s future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Such risks and uncertainties include, but are not limited to, the effect of current economic conditions on the Company’s industry, business, financial position and results of operations, the ability to maintain an effective system of internal control over financial reporting, fluctuations in revenues and operating income, the ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of competition, the ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Taiwan facility, the effect of foreign economic, political, legal and other risks on operations abroad, the uncertainty of patent litigation, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the inexperience of the Company in conducting clinical trials and submitting new drug applications, the ability to successfully conduct clinical trials, reliance on alliance and collaboration agreements, the availability of raw materials, the ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the ability to protect the Company’s intellectual property, exposure to product liability claims and other risks described in the Company’s periodic reports filed with the Securities and Exchange Commission. Forward-looking statements speak only as to the date on which they are made, and Impax undertakes no obligation to update publicly or revise any forward-looking statement, regardless of whether new information becomes available, future developments occur or otherwise.

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