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GSK gains Parkinson's disease drug rights

GSK has gained the rights to Impax's Parkinson's disease investigational product, outside the US and Taiwan, in a deal worth up to $186.5m

GlaxoSmithKline (GSK) has gained the rights to Impax Pharmaceuticals' Parkinson's disease investigational product, outside the US and Taiwan, in a deal worth up to $186.5m. 

The agreement relates to the development and commercialisation of IPX066 , Impax's novel extended release carbidopa-levodopa product currently in phase III clinical trials for the treatment of Parkinson's disease.

Under the terms of the agreement, Impax will receive an $11.5m upfront payment and is eligible to receive potential payments of up to $175m upon the successful achievement of development and commercialisation milestones. In return, GSK will receive an exclusive license to commercialise IPX066 in all territories except the US and Taiwan.

Impax will also receive tiered, double-digit royalty payments on GSK sales of IPX066. Impax will manufacture and supply IPX066 to GSK.

Michael Nestor, president of Impax Pharmaceuticals said: "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 commercialisation of IPX066." 

The IPX066 pharmacokinetic profile has the potential to offer reliable control of Parkinson's disease symptoms, such as the reduction in "off time" (the functional state when patients' medication effect has worn off and there is a return of Parkinson symptoms) throughout the day, which has been observed in preliminary studies of IPX066.

Impax will complete its current phase III programme for IPX066, which includes the recently completed APEX-PD trial in early PD. The results from the remaining Phase III study programme are expected to be available in 2011. 

"We are excited by the opportunity IPX066 represents to patients," commented, Atul Pande, senior vice president, Neurosciences Medicines Development Centre, GSK. "There is a significant need for a therapy which can improve on clinical symptom management and control in Parkinson's disease. 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."

Impax expects to file a new drug application (NDA) with the US Food and Drug Administration (FDA) for Parkinson's disease in late 2011 and will be responsible for commercialisation. In other regions, excluding Taiwan, GSK will be responsible for further development and registration of IPX066 and commercialisation of the product in those markets. 

16th December 2010

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