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EUROPEAN PARKINSON'S DISEASE ASSOCIATION
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GlaxoSmithKline and Impax Pharmaceuticals enter global agreement to develop and commercialise a late stage compound for Parkinson's

GlaxoSmithKline (GSK)
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Impax Pharmaceuticals

16 December 2010 - London, UK and Hayward, California

Press release

GlaxoSmithKline (GSK) and Impax Pharmaceuticals, the brand products division of Impax Laboratories, Inc. (Impax), today announced an agreement for the development and commercialisation 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.

Impax will complete the 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. In the U.S., Impax expects to file a New Drug Application 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. A team structure with representatives from both companies is being established to enable effective coordination of planned global regulatory and commercialisation activities.

“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 commercialisation for IPX066 for the treatment of Parkinson’s Disease,” stated Michael Nestor, President of Impax Pharmaceuticals.

"We are excited by the opportunity IPX066 represents to patients,” commented, Atul Pande, senior vice president, Neurosciences Medicines Development Center, 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.”


About IPX066

IPX066 is an investigational extended release carbidopa-levodopa product with an enhanced pharmacokinetic profile. The IPX066 pharmacokinetic profile has 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 programme for the registration of IPX066 in the U.S. includes the recently completed APEX-PD trial in early PD, the ADVANCE-PD study in advanced PD patients, an open label extension study for subjects from the ADVANCE-PD and APEX-PD studies. Additionally, for the European licence application, Impax is conducting the ASCEND-PD comparative study of IPX066 and carbidopa-levodopa and entacapone, which is currently enrolling patients.

GlaxoSmithKline – one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.  For further information please visit www.gsk.com.

About Impax Laboratories, Inc.

Impax Laboratories, Inc. is a technology based specialty pharmaceutical company applying its formulation expertise and drug delivery technology to the development of controlled-release and specialty generics in addition to the development of branded products. Impax markets its generic products through its Global Pharmaceuticals division and markets its branded products through the Impax Pharmaceuticals division. Additionally, where strategically appropriate, Impax has developed marketing partnerships to fully leverage its technology platform. Impax Laboratories is headquartered in Hayward, California, and has a full range of capabilities in its Hayward, Philadelphia and Taiwan facilities. For more information, please visit the Company's Web site at: www.impaxlabs.com.