Zogenix, Inc. (San Diego) and Desitin Pharmaceuticals GmbH (Hamburg, Germany) announced that the Danish Medicines Agency of Denmark has approved the Marketing Authorization Application (MAA) for SUMAVEL DosePro (sumatriptan injection) Needle-Free Delivery System. Denmark is the first country in Europe to grant marketing authorization for SUMAVEL DosePro for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache.
SUMAVEL DosePro offers fast acting, easy-to-use, needle-free subcutaneous administration of sumatriptan. SUMAVEL DosePro may offer a treatment alternative to oral and nasal triptans, and simple, convenient administration when compared to traditional, needle-based sumatriptan injection. These unique attributes may be ideally suited for challenging migraine attacks, such as morning migraines, fast onset migraine and migraines with vomiting.
Roger L. Hawley, Chief Executive Officer and Director of Zogenix said, “The MAA approval of SUMAVEL DosePro in Denmark creates a point of entry into the E.U. market. We look forward to the upcoming E.U. commercial launch by our partner Desitin.”
Desitin plans to launch SUMAVEL DosePro in Denmark in early 2011 and is responsible for pursuing additional MAA approvals and broader commercialization on a country-by-country basis under the E.U.
decentralized procedure.
Dr. Martin Zentgraf, Desitin’s General Manager, said, “We are pleased to announce the first MAA approval of SUMAVEL DosePro in Europe and anticipate commencing the commercial launch through our CNS-focused sales representatives and partner companies. We also have MAA submissions pending in other E.U. markets and look forward to gaining additional European approvals in the coming months.”
In March 2008, Zogenix and Desitin entered into a license agreement granting exclusive rights in the European Union to Desitin to develop and commercialize SUMAVEL DosePro. Zogenix and its co-promotion partner, Astellas, currently market SUMAVEL DosePro in the United States, where it has demonstrated consistent monthly growth in total prescriptions since its launch in January 2010.
Date: December 2, 2010
Source: Zogenix, Inc.
