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news.GlaxoSmithKline (GSK) and Impax Pharmaceuticals have entered into a global agreement for the development and commercialization of IPX066, Impax's novel extended release carbidopa-levodopa product for Parkinson's disease.
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Under the terms of agreement, GSK will obtain an exclusive license to commercialize IPX066 throughout the world, except in the US and Taiwan.
Impax will receive an upfront payment of $11.5m and is eligible to receive potential payments of up to $175m following the successful achievement of development and commercialization milestones.
Impax will also receive tiered, double-digit royalty payments based on GSK sales of IPX066, and Impax will manufacture and supply IPX066 to GSK.
Impax will complete the ongoing Phase III programme for IPX066 and its results are expected to be available in 2011.
Impax expects to file a new drug application for Parkinson’s disease in the US in late 2011, and will be responsible for commercialization.
In other regions, except Taiwan, GSK will take up the process of development and registration of IPX066 and commercialization of the product in those markets.
IPX066 is an investigational extended release carbidopa-levodopa product with an enhanced pharmacokinetic profile that has the potential to provide reliable control of Parkinson’s Disease symptoms.