Zogenix and Desitin Announce Filing for European Regulatory Approval of SUMAVEL(TM) D...( SAN DIEGO and HAMBURG Germany Oct. 28...),Health

SAN DIEGO and HAMBURG, Germany, Oct. 28 /PRNewswire/ -- Zogenix, Inc. ("Zogenix"), a privately held pharmaceutical company, and Desitin Pharmaceuticals GmbH ("Desitin"), a privately held, mid-sized German pharmaceutical company, today announced that Desitin has filed for European regulatory approval of SUMAVEL DosePro (sumatriptan injection) needle-free delivery system. The announcement follows successful completion of a European pivotal bioequivalence trial comparing needle-free SUMAVEL DosePro to a traditional needle-based autoinjector, Imigran®-Inject, the European brand of Imitrex STATdose System®. In March 2008, Zogenix and Desitin entered into a license agreement granting exclusive rights in the European Union to Desitin Pharmaceuticals GmbH ("Desitin") to develop and commercialize SUMAVEL DosePro.

SUMAVEL DosePro was recently approved by the U.S. FDA to treat acute migraine, with or without aura, and cluster headache, and will be launched by Zogenix in the U.S. in January 2010. SUMAVEL DosePro is a first-of-its-kind needle-free delivery system for subcutaneous sumatriptan, a treatment that provides migraine relief within 10 minutes for some patients. In clinical trials, the drug was shown to be absorbed rapidly, resulting in peak plasma concentrations within approximately 12 minutes. This rate of absorption of subcutaneous sumatriptan has been shown to correlate with rapid and complete relief of migraine symptoms, including migraine relief within 10 minutes for some patients and within 30 minutes for almost 50% of patients. Overall safety profiles were comparable for SUMAVEL DosePro and Imitrex STATdose System®.

"This filing demonstrates Desitin's ability to move this product candidate through development and into the European regulatory approval process," commented Dr. Martin Zentgraf, Desitin's General Manager. "Subject to regulatory approval, we look forward to launching it with our CNS-focused sales repr
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