Phase II trial of Impax Pharmaceuticals' Parkinson’s disease drug candidate successful

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>

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.