GSK, Impax: Positive Top-Line Results Of ASCEND-PD Phase III Study

GlaxoSmithKline PLC (GSK.LN) and Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (IPXL) said Monday announced positive top-line results of the ASCEND-PD Phase III clinical study of IPX066 versus carbidopa-levodopa plus entacapone, in patients with advanced Parkinson's disease.

MAIN FACTS:

-Impax plans to submit these data as part of its New Drug Application for IPX066 to the FDA, which is planned for the fourth quarter of 2011.

-GSK plans to file the Marketing Authorization Application for IPX066 in the European Union in 2012.

-IPX066 is an extended release capsule formulation of carbidopa-levodopa under investigation for the treatment of the motor symptoms of PD.

-The primary endpoint of this double blind crossover study was the percentage of "off time" during waking hours as measured by patient diary.

-"Off time" is the functional state when patients' medication effect has worn off and there is a return of the motor symptoms of PD.

-Patients entered the study with a baseline "off time" of 36.1% (5.9 hours), and at the end of the randomized IPX066 treatment phase patients had "off time" of 24.0% (3.8 hours) during waking hours compared to 32.5% (5.2 hours) for CLE (p<0.0001). This represents a 33.5% decrease in percent "off time" for IPX066 from baseline vs. a 10% decrease for CLE.

-Impax Pharmaceuticals and GSK are excited to report these positive results for the ASCEND-PD trial which demonstrate an 84 minute improvement in "off time" over CLE therapy with a corresponding increase in "on time" without troublesome dyskinesia.

-By Razak Musah Baba, Dow Jones Newswires; 44-20-7842-9275; razak.baba@dowjones.com

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