Aradigm Corporation (OTCBB:ARDM) (the "Company") today announced that Zogenix, Inc. ("Zogenix", Nasdaq:ZGNX) and Desitin Pharmaceuticals GmbH ("Desitin") were granted approval of the Marketing Authorization Application ("MAA") for SUMAVEL® DosePro™ (sumatriptan injection) needle-free delivery system for the acute treatment of migraine attacks, with or without aura, and the acute treatment of cluster headache by the Federal Institute for Drugs and Medical Devices of Germany (BrArM) and the Medicines and Healthcare products Regulatory Agency of the United Kingdom (MHRA). The approvals were received five weeks after receipt of the first European Union ("E.U.") approval for SUMAVEL DosePro in Denmark. According to Zogenix, Germany and the United Kingdom are two of the largest pharmaceutical markets in Europe. Aradigm is entitled to 3% royalty on net sales of SUMAVEL DosePro in all territories, including the US where this product is marketed by Zogenix and Astellas Pharma US, Inc.
Desitin is awaiting additional E.U. marketing authorizations and plans to launch SUMAVEL DosePro in Denmark and Germany in early 2011, and then follow with its U.K. launch. Germany is the reference member state for the SUMAVEL DosePro MAA through the E.U. Decentralized Procedure.
SUMAVEL DosePro offers fast acting, easy-to-use, needle-free subcutaneous administration of sumatriptan as a potential treatment alternative to oral and nasal triptans, and simple, convenient administration when compared to traditional, needle-based sumatriptan injection. According to Zogenix, these unique attributes may be ideally suited for challenging migraine attacks, such as morning migraines, fast onset migraines and migraines with vomiting.
In August 2006, Aradigm sold all of its assets related to the needle-free injector technology platform and products, including 12 United States patents along with foreign counterparts, to Zogenix. Aradigm is entitled to royalties from the sale of all products based on this technology platform.