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 by the Danish Medicines Agency of Denmark. 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. 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 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 European Union decentralized procedure.
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 injections. 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.
"We are very pleased that this exciting product is now entering the commercialization stage in Europe. It is also very gratifying that Zogenix, which has further developed SUMAVEL DosePro using the technology and product originally in development at Aradigm, launched the product in the US last January and the product is now being used by migraine sufferers," said Igor Gonda, CEO and President of Aradigm.
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.
SOURCE Aradigm Corporation