Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that it has completed enrollment in the ASCEND-PD trial. ASCEND-PD is a multinational Phase III comparative study of IPX066 to carbidopa-levodopa and entacapone in subjects with advanced Parkinson’s disease (PD). IPX066 is an investigational extended release capsule formulation of carbidopa-levodopa (CD-LD) intended to treat the motor symptoms of Parkinson’s disease. IPX066 is being developed in collaboration with GlaxoSmithKline (GSK) outside the US and Taiwan. “We are extremely pleased to have completed enrollment in ASCEND-PD, which is the third Phase III trial of IPX066 in PD subjects,” stated Suneel Gupta, chief scientific officer of Impax Pharmaceuticals. “The study compares IPX066 to another commonly used medication in advanced PD, and is intended to provide further safety and efficacy data on IPX066.” Impax plans to provide the top line results for this trial in late August of this year and continues to progress toward filing the new drug application in the fourth quarter of 2011. About the ASCEND-PD Study The ASCEND-PD study is a supportive Phase III study to compare the efficacy and safety of IPX066 to Carbidopa-Levodopa and Entacapone (CLE,) in subjects with advanced Parkinson’s disease. The trial is randomized, double-blind 2-treatment, 2-period crossover study of IPX066 and CLE. Study subjects currently taking a stable dose of CLE were enrolled into a six-week conversion onto IPX066 and then randomized to one of the two treatments for two weeks and then crossed over to the other for an additional two weeks. The study enrolled 110 subjects, with 90 subjects entering the randomized comparative phase of the study. The primary efficacy parameter is the percent “off time” during waking hours based on the subject PD diaries. Following the comparative phase, subjects were able to enroll in a six-month open-label extension phase.
About IPX066IPX066 is an investigational extended release capsule formulation of CD-LD with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has the potential to offer reliable control of PD motor symptoms. Impax Pharmaceuticals has previously announced the successful completion of two pivotal phase III trials in advanced PD subjects (ADVANCE-PD) and in early PD patients (APEX-PD). Open-label extension studies for subjects who have completed the ADVANCE-PD, APEX-PD, and ASCEND-PD studies are also ongoing. The Company plans to file a New Drug Application for IPX066 in PD in the fourth quarter of 2011. 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. 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 or a reduction in sales of any significant product, 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, 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.