Aradigm's first U.S. sale of SUMAVEL DosePro needle-free delivery system triggers $4M milestone payment

Feb 5 2010

Aradigm Corporation (OTCBB:ARDM) (the “Company”) announced today that it received the $4 million milestone payment from Zogenix, Inc. (“Zogenix”) based upon the first commercial sale in the U.S. of SUMAVEL* DosePro* (sumatriptan injection) needle-free delivery system. The Company will receive quarterly royalty payments on all SUMAVEL DosePro sales. In 2006, the Company sold all assets related to the Intraject* needle-free injector technology (now rebranded as DosePro) to Zogenix in exchange for milestone and royalty payments.

“The receipt of this milestone reflects our strategy to raise non-dilutive capital by monetizing non-strategic assets”

“The receipt of this milestone reflects our strategy to raise non-dilutive capital by monetizing non-strategic assets,” said Dr. Igor Gonda, the Company’s CEO and President. “We are pleased with the first commercial sale of this product utilizing technology developed at Aradigm.”

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 (under the skin) sumatriptan, a treatment that provides migraine relief, in a first-of-its-kind needle-free delivery system.

Migraine is a chronic and common neurovascular disorder characterized by episodic attacks. According to a 2004 report from the National Headache Foundation, approximately 30 million people in the U.S. suffer from migraines. Both men and women experience migraine, although women are three times more likely to suffer from it. Cluster headaches are characterized by groups or clusters of debilitating headaches lasting weeks or months, then disappearing for months or years. This type of headache affects an estimated one million sufferers in the U.S., and approximately 90 percent of these sufferers are male. Due to the severe nature of cluster headache, patients are commonly treated with prescription medication.

According to Zogenix, SUMAVEL DosePro offers several 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. 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 without a needle, which can offer fast relief in a patient-friendly delivery system.

Zogenix and Astellas Pharma US, Inc. (“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.