Impax Pharmaceuticals Reports Positive Results of Phase II Trial of IPX066, a Novel Formulation of Carbidopa-Levodopa for Parkinson's Disease

HAYWARD, Calif.--(BUSINESS WIRE)--Sep 21, 2009 - Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today reported the positive results from a recently completed Phase II trial of its late-stage Parkinson's Disease drug candidate IPX066

 

In this cross-over trial, IPX066 reduced subjects' “off” time during waking hours by 2 hours compared to Sinemet (3.8 hours of “off” time for IPX066 vs. 5.8 hours for Sinemet, P<0.0001), the standard of care in Parkinson's disease motor symptom management. “A reduction in “off” time of two hours represents a substantial improvement for Parkinson's patients”, said Robert A. Hauser, Professor of Neurology at the University of South Florida and a study investigator. “Patients desire sustained improvement of motor symptoms, beyond that afforded by currently available oral therapies,” he added. Corresponding effects were observed in the increase of “on” time with no or non-troublesome dyskinesias. In addition, IPX066 significantly improved duration of motor function compared to Sinemet, with an effect sustained over 6 hours, as measured by walking times (P=0.0023) and number of finger taps (P=0.0093).

 

The detailed results will be presented at the XVIII WFN World Congress on Parkinson's Disease and Related Disorders in Miami Beach, Florida, December 16 through December 19, 2009. The full abstract, entitled “Comparative Efficacy and Safety of a Novel Carbidopa-Levodopa Product (IPX066) and Sinemet® in Advanced Parkinson's Disease” will be made available in the meeting program and the conference website (www.kenes.com/parkinson) later in the year.

 

”We are very encouraged by these Phase II data and the potential for IPX066 to provide improvement over existing regimens in managing motor symptoms of Parkinson's disease,” stated Michael Nestor, president of Impax Pharmaceuticals. “These results, which include all treated patients, are consistent with the interim data announced earlier this year.”

 

The trial was a randomized, active-controlled, multi-center, one week per period, crossover study in 27 patients with advanced Parkinson's disease and compared the efficacy and tolerability of IPX066 to Sinemet. IPX066 was generally well tolerated and no unexpected treatment-related adverse events were reported in either treatment group.

 

Impax is currently enrolling patients in the Phase III APEX-PD study (www.apex-pd.com) of IPX066 in levodopa naive Parkinson's disease patients in North America and Europe and plans to commence a second Phase III trial of IPX066 in patients with advanced PD patients by early 2010.

 

About IPX066 and Parkinson's Disease (PD)

 

IPX066 is an investigational extended release carbidopa-levodopa product intended to produce a fast and sustained concentration of levodopa, potentially improving PD clinical symptom management. IPX066 has the potential to offer improved and more reliable control of PD symptoms, leading to clinically meaningful reductions in “off” time, a key objective in the management of PD. “Off-time” is the functional state when patients' medication effect has worn off and there is a return of Parkinson symptoms. In addition IPX066 extended release formulation is designed to reduce dosing frequency, enhancing patient convenience.

 

Parkinson's disease is a chronic neurodegenerative movement disorder affecting an estimated one million people in the U.S. About $1 billion per year is spent on medications to treat PD in the U.S.

 

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 and Philadelphia facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.

 

Sinemet® is a registered trademark of Bristol-Meyers Squibb Company

 

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Contact: Impax Pharmaceuticals

Mark Donohue, 215-933-3526

Sr. Director Investor Relations

 

 

 

 

Posted: September 2009

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