Zogenix, Inc., a privately held pharmaceutical company, and DesitinPharmaceuticals GmbH , a privately held, mid-sized Germanpharmaceutical company, today announced that Desitin has filed for Europeanregulatory approval of SUMAVEL DosePro (sumatriptan injection) needle-freedelivery system. The announcement follows successful completion of a Europeanpivotal bioequivalence trial comparing needle-free SUMAVEL DosePro to atraditional needle-based autoinjector, Imigran-Inject, the European brand ofImitrex STATdose System. In March 2008, Zogenix and Desitin entered into alicense agreement granting exclusive rights in the European Union to DesitinPharmaceuticals GmbH ("Desitin") to develop and commercialize SUMAVEL DosePro.SUMAVEL DosePro was recently approved by the U.S. FDA to treat acutemigraine, with or without aura, and cluster headache, and will be launched byZogenix in the U.S. in January 2010. SUMAVEL DosePro is a first-of-its-kindneedle-free delivery system for subcutaneous sumatriptan, a treatment thatprovides migraine relief within 10 minutes for some patients. In clinicaltrials, the drug was shown to be absorbed rapidly, resulting in peak plasmaconcentrations within approximately 12 minutes. This rate of absorption ofsubcutaneous sumatriptan has been shown to correlate with rapid and completerelief of migraine symptoms, including migraine relief within 10 minutes forsome patients and within 30 minutes for almost 50% of patients. Overall safetyprofiles were comparable for SUMAVEL DosePro and Imitrex STATdose System."This filing demonstrates Desitin's ability to move this product candidatethrough development and into the European regulatory approval process,"commented Dr. Martin Zentgraf, Desitin's General Manager. "Subject toregulatory approval, we look forward to launching it with our CNS-focusedsales representatives and partner companies in the major European countries,bringing this important product candidate to the market for the benefit ofpatients."
"SUMAVEL DosePro is a unique new product which we believe has broad globalappeal," said Roger Hawley, chief executive officer and director of Zogenix."With FDA approval and commercial manufacturing in place, Desitin'sachievement of this milestone in Europe with SUMAVEL DosePro will attract theattention of other companies who may be interested in our technology fordelivery of their drugs in other therapeutic areas, including biologics."