GlaxoSmithKline says that the second of three planned Phase III studies for a reformulated Parkinson's treatment partnered with Impax Laboratories turned in positive numbers, with patients in the study reporting significantly shortened "off time" for the drug.
Glaxo nabbed global rights to the drug--outside the U.S. and Taiwan--late last year in a deal with up to $186 million, believing that IPX066--Impax's second try at an an extended-release version of carbidopa-levodopa could significantly reduce the number of minutes each day in which their standard treatment wears off and the motor symptoms of the disease return. Today researchers said that patients given a regimen of carbidopa-levodopa plus entacapone registered 5.2 hours of "off time" compared to a much-improved 3.8 hours for the experimental drug arm.
"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," said Dr. Suneel Gupta, Impax Pharmaceuticals' chief scientific officer. "Consistent with our earlier ADVANCE-PD Phase III study findings, this study also demonstrates that IPX066 provides efficacy across a range of clinically meaningful measures in advanced PD. We are also pleased that the secondary endpoints supported the conclusion from the primary endpoint."
GlaxoSmithKline snagged ex-U.S. rights to the program with an $11.5 million upfront payment and a promise of $175 million in milestones. IPX066 is Impax's latest try for an extended release carbidopa-levodopa product, which is designed to help ease symptoms of the disease. The FDA rejected a similar product from Impax--Vadova--back in early 2008. A few months after that setback the company announced plans to launch a new development program to create a next-gen carbidopa-levodopa therapy that could leverage the experience it had gained trying to get an approval for Vadova. A third Phase III study is underway.
- check out the GSK release
- and here's the Reuters story