Zogenix, Inc. ("Zogenix"), a privately held pharmaceutical company, and Astellas Pharma U.S., Inc. ("Astellas") announced the U.S. commercial launch of SUMAVEL™ DosePro™ (sumatriptan injection) needle-free delivery system. In July 2009, the U.S. Food and Drug Administration approved SUMAVEL DosePro for the acute treatment of migraine, with or without aura, and the acute treatment of cluster headaches. SUMAVEL DosePro delivers subcutaneous sumatriptan, a treatment that provides migraine relief starting within 10 minutes for some patients, in a first-of-its-kind needle-free delivery system. SUMAVEL DosePro is expected to be available at most retail pharmacy outlets this month.

"Migraines can be disabling, with profound implications on quality of life," said Roger K. Cady, M.D., vice president of the National Headache Foundation board of directors and director of the Headache Care Center in Springfield, Mo. "One of the most common complaints of my migraine patients is that they would like to achieve faster relief. The availability of SUMAVEL DosePro makes it possible for patients to benefit from the fast relief of a subcutaneous formulation in a simple to use, needle-free delivery system."

SUMAVEL DosePro offers other practical benefits. Approximately 30 percent of patients report vomiting as a symptom of migraine attacks, and the vast majority of attacks are also accompanied by nausea(1). During these episodes, oral therapies may be an impractical treatment option. Further, while most forms of triptans can be effective when taken early in a migraine attack, patients who experience rapid onset of migraines, or those that occur upon waking may not always achieve the fast relief they would like from tablet and nasal forms. Quickly absorbed subcutaneous sumatriptan may offer an alternative for these patients, although until now, it was only available in a needle-based system. New SUMAVEL DosePro delivers sumatriptan subcutaneously (under the skin) without a needle, which can offer fast relief in a patient-friendly delivery system.

"We are extremely pleased to announce the introduction of SUMAVEL DosePro, which represents the first needle-free subcutaneous sumatriptan available to treat acute migraines," said Stephen Farr, Ph.D., president, chief operating officer and director of Zogenix. "Given its unique attributes, SUMAVEL DosePro offers a new, fast-acting, non-oral option for patients who suffer from migraine. We believe SUMAVEL DosePro has the potential to not only replace needle-based injectable forms of sumatriptan, but also tablet and nasal triptan forms for many migraine episodes."

Zogenix and Astellas have an exclusive co-promotion agreement to market SUMAVEL DosePro needle-free delivery system in the United States. Zogenix is focusing its sales activities primarily on the neurology market while Astellas is focusing principally on primary care physicians.

*In two well-controlled clinical trials (N=1104) with patients experiencing moderate or severe pain and one or more migraine symptoms, the efficacy of subcutaneous sumatriptan versus placebo was evaluated. In these clinical trials, 16 percent of patients achieved relief within 10 minutes versus 4 percent for placebo; 70 percent of patients achieved relief at one hour versus 22 percent for placebo (P