Aradigm Corporation recently announced it received the $4-million milestone payment from Zogenix, Inc. based upon the first commercial sale in the US 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,” 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 US FDA 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.

According to a 2004 report from the National Headache Foundation, approximately 30 million people in the US 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 1 million sufferers in the US, and approximately 90% 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% 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. have an exclusive co-promotion agreement to market SUMAVEL DosePro needle-free delivery system in the US. Zogenix is focusing its sales activities primarily on the neurology market, while Astellas is focusing principally on primary care physicians.

Aradigm is an emerging specialty pharmaceutical company focused on the development and commercialization of a portfolio of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists. The company has product candidates addressing the treatment of cystic fibrosis, bronchiectasis, inhalation anthrax infections, and smoking cessation.