Data on IPX066 APEX-PD Phase III Study for the Treatment of Early Parkinson's Disease to be Presented at the American Academy of Neurology Conference
HAYWARD, Calif.--(BUSINESS WIRE)--Apr 1, 2011 - 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
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
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.
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.
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.
Contact: Impax Pharmaceuticals
Investor Relations and Corporate Communications
Posted: April 2011