Upsher-Smith Announces Milestone In Development Of CNS Strategy

MAPLE GROVE, Minn., Dec. 3 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced the next phase of its strategic plan for central nervous system (CNS) diseases with USL255 (extended release topiramate), an internally developed program for the management of epilepsy. USL255 is being developed with Upsher-Smith's proprietary formulation technology and will enter a phase III clinical trial in early 2010 for the adjunctive treatment of epilepsy patients with partial onset seizures. USL255 is designed to provide convenient once daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

"Upsher-Smith's goal is to build our leadership position in the CNS field through three complementary strategies including: alliances and co-development agreements; leveraging development of our core competency in formulation development; and actively pursuing licensing and acquisitions," said Mark Evenstad, President of Upsher-Smith.

The USL255 program for epilepsy builds on Upsher-Smith's other CNS program, PRX1 for the symptomatic treatment of Parkinson's disease.  PRX1 is a co-development program with Proximagen Neuroscience, a biopharmaceutical company focused on CNS diseases. In July 2008, Upsher-Smith entered into a worldwide licensing agreement covering the development and commercialization of Proximagen's proprietary PRX1 program.

"The clinical development of USL255 and the PRX1 program with Proximagen are in line with Upsher-Smith's vision to become a leader in providing therapies that empower people suffering from CNS diseases to lead healthy, productive lives," said Evenstad. "These two milestones demonstrate our core competencies and commitment to bringing the highest quality pharmaceuticals to patients for more than eight decades."

About Epilepsy and Parkinson's Disease

Epilepsy is a neurological condition that produces seizures affecting a variety of mental and physical functions. Almost three million people in the U.S. have some form of active epilepsy with about 200,000 new cases of epilepsy diagnosed each year.[1]  Parkinson's disease is a chronic, progressive neurodegenerative disease that causes impairment in motor function, as well as many non-motor complications throughout the various stages of the disease.  As many as 1 million people in the U.S. suffer from Parkinson's disease, with 1 in 100 people over the age of 60 affected. [2]