Data from ASCEND-PD Phase III Study of IPX066 to be Presented at the American Academy of Neurology Conference
HAYWARD, Calif.--(BUSINESS WIRE)--Apr 18, 2012 - Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that data from the ASCEND-PD Phase III clinical study involving IPX066 will be presented in a Platform Presentation at the 64th Annual Meeting of the American Academy of Neurology in New Orleans, Louisiana, held from April 21 to April 28. IPX066 is an investigational, patented extended release capsule formulation of carbidopa-levodopa (CD-LD) intended for the treatment of idiopathic Parkinson's disease. IPX066 is being developed in collaboration with GlaxoSmithKline (GSK) for territories countries outside the U.S. and Taiwan.
The presentation information is as follows:
Title: Comparison of IPX066, a Novel Investigational Carbidopa-Levodopa (CD-LD) Extended-Release Formulation, and CD-LD-Entacapone (CLE) in Advanced Parkinson's Disease (ASCEND-PD Trial)
Date: April 24, 2012
Time: 2:00 p.m.
Location: New Orleans Ernest N. Memorial Convention Center
Scientific Session: S02 (Treatment of Parkinson's Disease)
Abstract Number: S02.005
About the ASCEND-PD study
The ASCEND-PD study is a randomized, double-blind 2-treatment, 2-week crossover study of IPX066 and CLE (a combination treatment of carbidopa-levodopa and entacapone, an enzyme inhibitor of levodopa breakdown), and one of three Phase III studies of IPX066. Study subjects taking a stable dose of CLE were converted to IPX066 over a six-week period, then randomized to one of the two treatments (IPX066 or CLE) for two weeks and then crossed over to the other treatment for an additional two weeks after a one-week washout with IPX066. The study enrolled 110 subjects, and a total of 84 subjects completed the randomized double-blind comparative phase of the study. Following the comparative phase, subjects were enrolled into a six-month open-label extension study.
IPX066 is an investigational extended release capsule formulation of CD-LD which is intended to maintain consistent plasma concentration of levodopa for a longer duration versus immediate release levodopa, which may have an impact on fluctuations in clinical response. It is not approved or licensed anywhere in the world. In December 2011, Impax filed a New Drug Application (NDA) for IPX066 intended for the treatment of idiopathic Parkinson's disease (PD), which is currently undergoing review by the U.S. Food and Drug Administration (FDA).
Results from the pivotal phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced.
About the Impax GSK collaboration
Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066 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, with a full range of capabilities located in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.
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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, fluctuations in the Company's revenues and operating income, the Company's ability to successfully develop and commercialize pharmaceutical products, reductions or loss of business with any significant customer, the impact of consolidation of the Company's customer base, the impact of competition, the Company's ability to sustain profitability and positive cash flows, any delays or unanticipated expenses in connection with the operation of the Company's Taiwan facility, the effect of foreign economic, political, legal and other risks on the Company's operations abroad, the uncertainty of patent litigation, increased government scrutiny on the Company's agreements with brand pharmaceutical companies, consumer acceptance and demand for new pharmaceutical products, the difficulty of predicting Food and Drug Administration filings and approvals, the Company's inexperience in conducting clinical trials and submitting new drug applications, the Company's ability to successfully conduct clinical trials, the Company's reliance on third parties to conduct clinical trials and testing, the availability of raw materials and impact of interruptions in the Company's supply chain, the use of controlled substances in the Company's products, disruptions or failures in the Company's information technology systems and network infrastructure, the Company's reliance on alliance and collaboration agreements, the Company's dependence on certain employees, the Company's ability to comply with legal and regulatory requirements governing the healthcare industry, the regulatory environment, the Company's ability to protect the Company's intellectual property, exposure to product liability claims, changes in tax regulations, the Company's ability to manage the Company's growth, including through potential acquisitions, the restrictions imposed by the Company's credit facility, uncertainties involved in the preparation of the Company's financial statements, the Company's ability to maintain an effective system of internal control over financial reporting, any manufacturing difficulties or delays, the effect of terrorist attacks on the Company's business, the location of the Company's manufacturing and research and development facilities near earthquake fault lines 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 Laboratories, Inc.
Investor Relations and Corporate Communications
Posted: April 2012