Impax submits IPX066 NDA to FDA for treatment of Parkinson's

Impax Pharmaceuticals, the branded products division of Impax Laboratories, Inc. (NASDAQ: IPXL) today announced the submission of Impax's New Drug Application (NDA) for IPX066 to the U.S. 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 U.S. 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 U.S., 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 U.S. 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 U.S. 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."