Impax Pharmaceuticals will receive $11.5 million up front from GlaxoSmithKline (GSK) as part of the firms’ development and commercialization deal for Impax’ late-stage Parkinson disease (PD) therapeutic IPX066. The agreement gives GSK an exclusive license to develop and commercialize IPX066 worldwide, excluding the U.S. and Taiwan.
Impax will be responsible for completing the ongoing Phase III program for the drug in the U.S., and says it expects to file an NDA in late 2011. GSK will shoulder the development, regulatory, and commercialization activities for IPX066 in all other territories except Taiwan. The partners are also setting up a team to help coordinate regulatory and commercialization activities worldwide.
Impax could receive up to $175 million in development and commercialization milestones plus double-digit royalty payments from sales of IPX066 by GSK in its designated territories. “GSK is an ideal partner for IPX066, combining global best-in-class development, regulatory and commercial experience in Parkinson disease, which will be an asset in the successful commercialization of IPX066,” remarks Michael Nestor, Impax Pharmaceuticals president.
IPX066 is an extended-release carbidopa-levodopa therapy with an enhanced pharmacokinetic profile, Impax claims. The drug is formulated to produce a fast and more sustained concentration of levodopa, which is expected to lead to clinically relevant reductions in off-time, as well as reduce the required dosing frequency. The Phase III program for the drug includes the recently completed Apex-PD study in early PD patients, the Advance-PD trial in advanced PD patients, and open-label extensions for participants in both Apex-PD and Advance-PD. Completion of the Advance-PD study is expected in early 2011. In Europe the ongoing Ascend-PD study is comparing IPX066 therapy with carbidopa-levodopa, and with entacapone.
In November Impax reported positive top-line results from the Apex-PD study. The trial met its primary efficacy endpoint of change from baseline in the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Parts II and III score at end of study. All three doses of IPX066 showed significant improvements compared to placebo. The mean sum of Parts II and III UPDRS score improved 36% among IPX066-treated patients, compared with a 2% improvement for placebo-treated participants. IPX066 therapy also led to a 72% mean improvement in both the Clinician Global Impression of change (CGI) and Patient Global Impression of change (PGI) ratings. The placebo cohort demonstrated improvements of 27% and 34% CGI and PGI, respectively
Impax Pharmaceuticals operates as the branded products division of Impax Laboratories. The unit is a neurology-focused, specialty pharmaceutical company focused on developing products for CNS disorders including PD and Alzheimer disease, multiple sclerosis, epilepsy, attention deficit disorder, migraines, depression, and schizophrenia. The firm says it aims to push on with development of IPX066 before committing resources to other potential pipeline products.