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Agreements

Date: 2013-04-29

Type of information: Development agreement

Compound: IPX066 (known as RYTARY™ in the U.S.)

Company: GSK (UK) Impax Pharmaceuticals (USA - CA)

Therapeutic area: Neurodegenerative diseases - CNS diseases

Type agreement:

development
commercialisation

Action mechanism:

RYTARY™ is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease.

Disease: symptomatic treatment of adult patients with idiopathic Parkinson’s disease

Details:

Impax Pharmaceuticals, the brand products division of Impax Laboratories, has announced that Impax and GSK are terminating their collaboration for the development and commercialisation of IPX066 outside the United States (U.S.) and Taiwan. IPX066 (known as RYTARY™ in the U.S.) is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson’s disease and is not approved anywhere in the world. Under the terms of the agreement entered into in December 2010, GSK’s right to develop and commercialize IPX066 outside the U.S. and Taiwan will transfer back to Impax effective at the end of July 2013. The decision has been reached because of delays in the anticipated regulatory approval and launch dates in countries in which GSK has rights to commercialize the product. Impax intends to initiate activities to find a partner or partners for markets outside the U.S. looking to grow their non-US neurology franchise.

Financial terms:

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Is general: Yes