LONDON & HAYWARD, Calif.—GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the brand products division of Impax Laboratories Inc. have announced an agreement for the development and commercialization of IPX066, Impax's novel extended release carbidopa-levodopa product, outside the United States and Taiwan. IPX066, an investigational product under development for the treatment of Parkinson's Disease (PD), is currently in Phase III clinical trials.
Under the terms of the agreement, GSK will receive an exclusive license to sell IPX066 throughout the world except in the United States and Taiwan. Impax will receive an $11.5 million upfront payment and is eligible to receive potential payments of up to $175 million upon the successful achievement of development and commercialization milestones. Impax will also receive tiered, double-digit royalty payments on GSK sales of IPX066. Impax will manufacture and supply IPX066 to GSK.
Impax will complete the current Phase III program for IPX066, which includes the recently completed APEX-PD trial in early PD. The results from the remaining Phase III study program are expected to be available in 2011. In the United States, Impax expects to file a New Drug Application for Parkinson's Disease in late 2011 and will be responsible for commercialization. In other regions, excluding Taiwan, GSK will be responsible for further development and registration of IPX066 and commercialization of the product in those markets. A team structure with representatives from both companies is being established to enable effective coordination of planned global regulatory and commercialization activities.
"GSK is an ideal partner for IPX066, combining global best-in-class development, regulatory and commercial experience in Parkinson's Disease, which will be an asset in the successful commercialization of IPX066," says Michael Nestor, president of Impax Pharmaceuticals.
"There is a significant need for a therapy which can improve on clinical symptom management and control in Parkinson's disease," notes Atul Pande, senior vice president, Neurosciences Medicines Development Center, GSK. "We look forward to collaborating with Impax and hope to deliver an improved treatment option to the millions of people living with this devastating disease."
IPX066 is an investigational extended release carbidopa-levodopa product with an enhanced pharmacokinetic profile that is said to have the potential to offer reliable control of Parkinson's disease symptoms, such as the reduction in "off time" throughout the day, which has been observed in preliminary studies of IPX066. "Off time" is the functional state when patients' medication effect has worn off and there is a return of Parkinson symptoms.
The phase III clinical development program for the registration of IPX066 in the United States includes the recently completed APEX-PD trial in early Parkinson's disease, the ADVANCE-PD study in advanced Parkinson's disease subjects, an open label extension study for subjects from the ADVANCE-PD and APEX-PD studies. Additionally, for the European application, Impax is conducting the ASCEND-PD comparative study of IPX066 and carbidopa-levodopa and entacapone, which is currently enrolling subjects.
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