MAPLE GROVE, Minn., April 12 Upsher-Smith Laboratories, Inc. today signed an agreement with Proximagen Neuroscience plc to obtain exclusive rights in North America for the investigational drug tonabersat, a first-in-class neuronal gap junction modulator. Tonabersat has been tested in a variety of neurological conditions, including migraine and epilepsy.
Upsher-Smith will be responsible for development, regulatory filing and commercialization activities for tonabersat in North America. Based on results of preclinical models of seizures, Upsher-Smith will focus on development of tonabersat for the treatment of epilepsy.
"This agreement supports our strategic vision of building a leadership position in the central nervous system field," said Mark Evenstad, President of Upsher-Smith. "We are excited about our growing CNS development portfolio that we hope will provide benefit to patients suffering from neurologic conditions." Upsher-Smith focuses on the development of pharmaceuticals in epilepsy and Parkinson's disease, CNS disorders with significant unmet medical needs.
The company is also developing an extended-release topiramate (USL255) for the management of epilepsy using the company's proprietary formulation technology. USL255, which is targeted to enter Phase III clinical trials in the first half of 2010 for the adjunctive treatment of epilepsy patients with partial onset seizures, is designed to provide convenient once-daily dosing and reduce fluctuations in topiramate blood levels observed with currently available topiramate options.
CNS program PRX1, a co-development program with Proximagen Neuroscience, is in development for the symptomatic treatment of Parkinson's disease. In July 2008, Upsher-Smith entered into a worldwide licensing agreement for the development and commercialization of the PRX1 program.
Upsher-Smith Laboratories, Inc., founded in 1919, is a rapidly growing, privately held pharmaceutical company that develops, manufactures, and markets branded and branded generic 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.
About Proximagen Neuroscience Plc
Proximagen Neuroscience plc (AIM: PRX) is a publicly traded biotechnology company focused on the development and commercialization of novel therapeutics for diseases of the central nervous system. The Company's strong balance sheet makes Proximagen one of the best capitalized biotechnology companies in the small and mid cap European biotech sector. Proximagen is developing a broad pipeline of drug candidate programs and has plans for substantial future growth through a strategy of acquisition and consolidation in its preferred therapeutic area of the central nervous system.
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)
1. Epilepsy Foundation. Available at: http://www.epilepsyfoundation.org/about/. Accessed on April 2, 2010.
2. National Parkinson Foundation. Available at: http://www.parkinson.org/home.aspx. Accessed on April 2, 2010.
SOURCE Upsher-Smith Laboratories, Inc.