The US Food and Drug Administration (FDA) has accepted for filing the Impax Pharmaceuticals’ New Drug Application (NDA) for IPX066 for the treatment of idiopathic Parkinson’s disease (PD) submitted to the Agency on December 21, 2011. IPX066 is a patented extended release capsule formulation of carbidopa-levodopa (CD-LD). The Prescription Drug User Fee Date (PDUFA) for a decision by the FDA is October 21, 2012. IPX066 has been licensed to GlaxoSmithKline (GSK) for countries outside the U.S. and Taiwan for development and marketing.

IPX066 has undergone extensive clinical development, including multiple studies in early and advanced PD in the US and in Europe. The NDA included data from three controlled phase III studies and two open label extensions of IPX066 in both early and advanced PD. IPX066 has been investigated in more than 1,000 subjects.

IPX066 is an investigational extended release capsule formulation of CD-LD which is intended to maintain consistent plasma concentration of levodopa for a longer duration versus immediate release levodopa, which may have an impact on fluctuations in clinical response. It is not approved or licensed anywhere in the world.

Results from the pivotal phase III studies of IPX066, APEX-PD (early PD), ADVANCE-PD (advanced PD) and ASCEND-PD (advanced PD) have previously been announced. Results of the ASCEND-PD study have been accepted for presentation to the American Academy of Neurology April 2012.

Impax Pharmaceuticals and GSK announced an agreement for the development and commercialization of IPX066 in December 2010. Under the terms of the agreement, GSK received an exclusive license to register and commercialize IPX066 throughout the world except in the US and Taiwan.

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.