Impax Pharmaceuticals, a technology-based specialty pharmaceutical company, has submitted New Drug Application (NDA) for IPX066 to the US Food and Drug Administration (FDA) for the treatment of idiopathic Parkinson’s disease (PD).

IPX066 is a patented extended release capsule formulation of carbidopa-levodopa (CD-LD). IPX066 is being developed in collaboration with GlaxoSmithKline (GSK) for territories outside the US and Taiwan.

“In just three and a half years, Impax’s brand research and development team has successfully advanced IPX066 from an Investigational New Drug (IND) through multiple clinical studies of efficacy and safety, culminating in our NDA submission,” said Michael Nestor, president of Impax Pharmaceuticals. “This event demonstrates our strong internal capability to develop neurology products to fulfill unmet clinical needs of the PD community. IPX066 represents a significant commercial opportunity for Impax in the US, which if approved we plan to commercialize with our specialty neurology sales team.”

IPX066 has undergone extensive clinical development, including multiple studies in early and advanced PD in the US and in Europe. As agreed with the FDA, the NDA is being submitted as a 505(b)(2) application and includes data from three controlled phase III studies and two open label extensions of IPX066 in early and advanced PD. In these studies, IPX066 has been studied in about 900 PD subjects. Impax held an end of phase III meeting with the US FDA in the third quarter of 2011 and is submitting its NDA consistent with the guidance it received.

“We are proud to achieve this important milestone in our development of the brand pharmaceutical business,” said Larry Hsu, Ph.D., president and CEO of Impax Laboratories, Inc. “This represents an important part of our strategy to diversify our business model to branded products, with the objective of improving long-term shareholder value.”

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 and other IPX066 data are planned for submission to the American Academy of Neurology and International Congress of Parkinson’s Disease and Movement Disorders Conference in April and June 2012, respectively.

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 U.S. and Taiwan.

Parkinson’s disease is a chronic neurodegenerative movement disorder affecting over three million people in the US, Europe, and Japan.

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.