Aradigm Corporation Surges on Sumavel DosePro Approval
Aradigm Corporation (ARDM) shares jumped nearly 20 percent after Zogenix announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Sumavel DosePro needle-free delivery system to treat acute migraine and cluster headache.
Aradigm Corporation [[ARMD.OB]], a specialty pharmaceutical company focused on the development and commercialization of drugs delivered by inhalation for the treatment of severe respiratory diseases by pulmonologists, saw its shares rise nearly 20 percent after Zogenix announced that it received approval from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for Sumavel DosePro.
According to Aradigm’s 10-Q filing, it received a $4 million initial payment from Zogenix, and it will be entitled to a milestone payment upon initial commercialization, and royalty payments upon commercialization of DosePro products. The royalty payment amounts were unspecified, but Aradigm stands to profit from the FDA’s approval, and investors will be able to see the amounts in future financial statements when the income is reported.
According to Wolters Kluwer Health, Triptans are a $3.3 billion market in the U.S. with nearly 30 million Americans affected by migraines. While the majority of the products on the market come in the form of tablets, there is substantial demand for something more effective. Fast-acting, non-oral options, like DosePro, are needed particularly for those who experience migraine episodes associated with sudden onset, walking, nausea or vomiting.
CEO Roger Hawley commented, “During market research sessions with health care providers and migraine patients, ‘cool’ was one of the most common responses to Sumavel DosePro – that’s a very unusual description in this industry. We believe our novel DosePro delivery system could transform the future of subcutaneous drug delivery of pharmaceuticals. This first approval was made possible by years of dedication and shared entrepreneurial spirit.”
In the end, the approval of Sumavel DosePro is great news for Aradigm given its entitlement to royalty payments on sales. The amount of these payments remains uncertain, but investors should get a better idea in future financial statements when the income is recorded. As a result, long-term investors may want to take a closer look at this growing company.
CONTACT: Daniel Minton, Managing Director, 406-862-5400, daniel@accelerize.com