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Xcel Pharmaceuticals, Inc. Acquires Retigabine, A Late-Stage Development Product Candidate For Epilepsy



10/19/2005 5:09:53 PM

SAN DIEGO, Feb. 2 /PRNewswire/ -- Xcel Pharmaceuticals, Inc. (Xcel) today announced that it has acquired from VIATRIS GmbH and Co. (VIATRIS) exclusive worldwide product rights to retigabine, a late-stage development product candidate for the treatment of epilepsy. Xcel will have complete responsibility for retigabine, including worldwide clinical development, regulatory approval and commercialization. Deal terms were not disclosed. Xcel intends to hold an end of Phase II meeting with the FDA in 2004 and plans to initiate the pivotal Phase III clinical program in 2005. With its focus in the United States, Xcel plans to seek partners to co-develop and commercialize retigabine throughout the rest of the world.

"A key part of our corporate strategy is to acquire and advance late-stage development product candidates in central nervous system (CNS) disorders that, upon approval, will leverage our existing commercial organization and relationships with the neurology physician community," stated Michael T. Borer, Xcel's President and Chief Executive Officer of Xcel. "By acquiring retigabine, we are expanding our CNS product portfolio, which includes four products, two that are used to treat epilepsy and two that are used to treat migraine, and two product candidates, one to treat migraine and now one to treat epilepsy. The acquisition of retigabine adds to our future revenue pipeline and enhances the long-term value we are creating for our stakeholders."

A leading epileptologist and professor of Neurology at the University of Pennsylvania School of Medicine and Co-Director of the Penn Epilepsy Center, Jacqueline A. French, M.D., commented, "Retigabine appears to be a promising anti-epileptic drug with a novel mechanism of action. Drugs with novel mechanisms offer hope to refractory epilepsy patients who do not respond to current therapies."

Dr. Heinz Kipper, VIATRIS' Chief Executive Officer stated, "We are confident that Xcel will be able to tap the remarkable potential of this novel compound and build upon the initial success of retigabine's development for the treatment of epilepsy, as demonstrated by the Phase IIb trial data."

Retigabine

Retigabine is a product candidate in development as an adjunctive treatment for partial-onset seizures in patients with epilepsy. It is a new chemical entity that combines a novel mode of action, selective opening of potassium channels, with a known anti-epileptic mechanism, potentiation of gamma-aminobutyric acid, or GABA-evoked currents. Retigabine has been the subject of a comprehensive development program and is one of the most clinically advanced anti-epileptic drug candidates. Most recently, it was evaluated in a multinational study that included 399 patients with refractory partial-onset seizures at investigative sites in the United States, Europe and Australia. The results of this large, randomized, double-blind, placebo-controlled, Phase IIb study met prospectively defined endpoints. Over 1,000 human subjects, including 600 epilepsy patients, have been exposed to retigabine thus far. The total human exposure is over 800 patient years, with more than 200 patients treated for one year and more than 100 patients treated for two years. Due to its broad spectrum of action, retigabine could potentially be used for further study in the treatment of other CNS disorders including neuropathic pain, bipolar disorder and attention deficit/hyperactivity disorder. It already has demonstrated activity in preclinical animal models for neuropathic pain. Retigabine is protected by a broad patent estate currently comprised of more than 180 issued patents and patent applications worldwide.

Epilepsy Market

Approximately 2.5 million people in the United States have epilepsy with 181,000 new cases diagnosed each year. Of the 2.5 million people with epilepsy, approximately 30% of, or 750,000, patients are refractory to currently available anti-epileptic drugs and could benefit from new treatment options to help patients with recurrent seizures. Sales of products in the United States used to treat epileptic seizures totaled approximately $6.5 billion in 2003, and grew at an average annual rate of 23% from 1999 to 2003.

Approximately 50 million people worldwide have epilepsy with an incidence of 2 million new cases annually. Of the 50 million people with epilepsy, approximately 85% of, or 42.5 million, people live in developing countries. In the seven major pharmaceutical markets comprised of the United States, France, Germany, Italy, Spain, the United Kingdom and Japan, epilepsy affects approximately 4.1 million people.

About Xcel Pharmaceuticals, Inc.

Xcel Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on prescription products that treat disorders of the central nervous system (CNS). Xcel's portfolio includes four products, two that are used to treat epilepsy and two that are used to treat migraine, and two product candidates, one to treat epilepsy and one to treat migraine. The Company's 96-person nationwide field sales organization promotes its products to high-prescribing epilepsy and migraine specialists. Xcel's strategy is to increase prescription demand for its lead products through targeted sales and marketing efforts, to successfully develop and commercialize its late-stage development product candidates, to leverage its CNS presence through the acquisition of additional late-stage development product candidates and commercial products, and to develop enhancements for its current products. For more information about Xcel Pharmaceuticals, please visit http://www.xcelpharmaceuticals.com/ . For more information about Xcel's products, please visit http://www.diastat.com/ , http://www.migranal.com/ , http://www.dhe45.com/ , and http://www.choosemysoline.com/ .

Forward Looking Statement

This press release contains forward-looking statements including targets, estimates, plans, expectations, goals and projections, which involve risks and uncertainties, including risks associated with our ability to fund, successfully develop and obtain regulatory approvals for retigabine, our ability to commercialize and grow prescriptions of retigabine if approved, our ability to meet financial commitments to VIATRIS, our dependence on VIATRIS and third parties for manufacturing, the competitiveness of the pharmaceutical industry, and other risks. Actual results may differ from those projected in any forward-looking statements. Any forward-looking statements represent our best judgment at this time and are based on assumptions, factors and other conditions that could change. Any such changes could produce significantly different results. We are not obligated to update or revise any of our forward-looking statements even if experience or future events show that the projected results or events will not be realized.

Xcel Pharmaceuticals, Inc.

CONTACT: Michael T. Borer, President and Chief Executive Officer,+1-858-202-2719, or John R. Cook, Senior Vice President, Corporate Operations,+1-858-202-2721, both of Xcel Pharmaceuticals, Inc.


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