Impax Pharmaceuticals Awarded Michael J. Fox Foundation Grant for Ongoing Research of IPX066 for Parkinson's Disease
HAYWARD, Calif.--(BUSINESS WIRE)--Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL), has been awarded funding of up to $400,000 by The Michael J. Fox Foundation for ongoing clinical research of the Company's investigational carbidopa-levodopa extended release (CD-LD ER) product IPX066, which is intended to treat the motor symptoms of Parkinson's disease (PD).
"We appreciate the support and recognition of The Michael J. Fox Foundation as we further advance the development of IPX066 for Parkinson's disease"
The funding will support a planned dosing conversion study of CD-LD ER to IPX066, to be followed by an open-label extension safety study of IPX066 in subjects with advanced PD.
"One of our priorities is to improve symptomatic treatments for patients today," said Brian Fiske, Ph.D., director of research programs at the Michael J. Fox Foundation. "IPX066 holds promise as a potentially useful future treatment option for PD. By collaborating with Impax Pharmaceuticals to develop additional clinical data about IPX066, we hope to gather important information for physicians treating PD and their patients."
"We appreciate the support and recognition of The Michael J. Fox Foundation as we further advance the development of IPX066 for Parkinson's disease," said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc.
IPX066 is an investigational CD-LD ER 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 studies of IPX066.
Impax Pharmaceuticals has successfully completed two required phase III trials in advanced PD patients (ADVANCE-PD) and early PD patients (APEX-PD). With the completion of these studies, the Company is working diligently to file a New Drug Application in the fourth quarter of 2011. The Company is also conducting the ASCEND-PD comparative study of IPX066 and carbidopa-levodopa and entacapone, and an Open-Label Extension study for subjects from the ADVANCE-PD and APEX-PD studies is also ongoing.
About The Michael J. Fox Foundation
As the world's largest private funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding over $240 million in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world.
For more information, visit: www.michaeljfox.org; www.facebook.com/michaeljfoxfoundation.
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 Laboratories 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.
Impax Laboratories, Inc.
Sr. Director, Investor Relations and Corporate Communications