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Upsher-Smith Laboratories Announces Initiation of Phase III Clinical Trial of USL255 (Extended-Release Topiramate) for Adjunctive Treatment of Partial-Onset Epilepsy
Date:6/14/2010

MAPLE GROVE, Minn., June 14 /PRNewswire/ -- Upsher-Smith Laboratories, Inc. today announced the initiation of a global Phase III clinical trial for USL255 (extended-release topiramate), an internally developed program for the management of epilepsy in adults, using the company's proprietary formulation technology.  USL255 is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.

"The initiation of the Phase III trial for USL255 is a key milestone in Upsher-Smith's vision of becoming a leader in the CNS field," said Alan Rauch, M.D., Chief Medical Officer and Vice President Medical & Regulatory Affairs.  "There is a significant unmet need in the treatment of epilepsy, with as many as 30 percent of patients not adequately controlled using current antiepileptic drugs.  Poor medication compliance may be a contributing factor, and we are excited about the potential for USL255 to offer patients and clinicians a new treatment option with the potential for improved compliance."

The Phase III trial is a randomized, multinational, double-blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of USL255 in patients 18 to 75 years of age with refractory partial-onset seizures with or without secondary generalized seizures.  Further information on this clinical study can be found at http://www.clinicaltrials.gov/ct2/show/NCT01142193?term=upsher&rank=2.

USL255 is the lead investigational drug in Upsher-Smith's expanding CNS development pipeline that includes two other investigational drug programs.  In April 2010, the company obtained exclusive rights in North America for the investigational drug tonabersat, a first-in-class neuronal gap junction modulator. Based on results of preclinical models of seizures, Upsher-Smith will focus on development of tonabersat for the treatment of epilepsy. In July 2008, Upsher-Smith entered into a worldwide licensing agreement with Proximagen Neuroscience Plc for the development and commercialization of the PRX1 program for the symptomatic treatment of Parkinson's disease.

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)

About Upsher-Smith

Upsher-Smith Laboratories, Inc., founded in 1919, is a rapidly growing, privately held pharmaceutical company that develops, manufactures, and markets prescription and over-the-counter products.  Upsher-Smith's product portfolio focuses in the areas of women's health, dermatology, cardiology, and central nervous system diseases.  The company's growing CNS pipeline concentrates on diseases with significant unmet need, including epilepsy and Parkinson's disease.  To expand its CNS pipeline, Upsher-Smith seeks alliances and co-development programs, pursues licensing and acquisitions, and leverages the development of its core competency in formulation development.  For more information, visit www.upsher-smith.com.

1. Epilepsy Foundation. Available at: http://www.epilepsyfoundation.org/.  Accessed on May 19, 2010.

2. The Michael J. Fox Foundation for Parkinson's Research. Available at: http://www.michaeljfox.org/.  Accessed on May 19, 2010.


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