12.16.10
GlaxoSmithKline and Impax Pharmaceuticals entered an agreement for the development and commercialization of IPX066, Impax’s extended release carbidopa-levodopa product, outside the U.S. and Taiwan. IPX066 is an investigational drug under development for the treatment of Parkinson’s Disease (PD), and is currently in Phase III trials.
GSK will have an exclusive license to sell IPX066 throughout the world except in the U.S. and Taiwan. Impax will receive $11.5 million upfront and is eligible to receive potential milestone payments of as much as $175 million upon successful development and commercialization. Impax will also receive royalty payments on GSK sales of the drug. Impax will manufacture and supply IPX066 to GSK.
Impax will complete its current Phase III program, with results expected in 2011. In the U.S., Impax plans to file a NDA for PD in late 2011 and will be responsible for commercialization. In other regions, excluding Taiwan, GSK will be responsible for further development, registration and commercialization of IPX066 in those markets.
“We are very pleased to announce this development and collaboration agreement with GSK, which is a significant milestone in the development of Impax Pharmaceuticals and an important achievement in the planned global commercialization for IPX066 for the treatment of Parkinson’s Disease,” said Michael Nestor, president of Impax Pharmaceuticals. “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.”
GSK will have an exclusive license to sell IPX066 throughout the world except in the U.S. and Taiwan. Impax will receive $11.5 million upfront and is eligible to receive potential milestone payments of as much as $175 million upon successful development and commercialization. Impax will also receive royalty payments on GSK sales of the drug. Impax will manufacture and supply IPX066 to GSK.
Impax will complete its current Phase III program, with results expected in 2011. In the U.S., Impax plans to file a NDA for PD in late 2011 and will be responsible for commercialization. In other regions, excluding Taiwan, GSK will be responsible for further development, registration and commercialization of IPX066 in those markets.
“We are very pleased to announce this development and collaboration agreement with GSK, which is a significant milestone in the development of Impax Pharmaceuticals and an important achievement in the planned global commercialization for IPX066 for the treatment of Parkinson’s Disease,” said Michael Nestor, president of Impax Pharmaceuticals. “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.”