Avanir in $20m migraine deal
California-based biopharma company, Avanir Pharmaceuticals, has entered into a $20 million exclusive North American license agreement with OptiNose AS for the development and commercialization of a new migraine treatment. OptiNose’s novel Breath Powered intranasal delivery system contains a low-dose sumatriptan powder to treat acute migraine.
Under terms of the agreement, as well as the upfront $20 million payment by Avanir, OptiNose is also eligible to receive up to $90 million if the product reaches certain clinical, regulatory and commercial milestones. Avanir will become responsible for the regulatory, manufacturing and commercialization activities for the investigational product.
“The large migraine market is characterized by a high level of dissatisfaction. OptiNose has developed a unique device that has the potential to transform the clinical profile of the leading migraine drug, resulting in a new product candidate that we believe can significantly improve upon the current treatment options. In clinical trials, this innovative and easy-to-use device has demonstrated rapid absorption and migraine relief using approximately 80% less drug than the most commonly prescribed oral sumatriptan. This NDA-ready asset fits well with our current commercial infrastructure and is strategically aligned with strengthening our position as a leading CNS specialty company.”
Greg Flesher, senior vice president of corporate development and chief business officer of Avanir Pharmaceuticals.
Phase 3 clinical trial results of sumatriptan in 212 patients with moderate to severe migraines found that 68% experienced headache relief after two hours. The trial showed that patients began to experience headache relief as quickly as 15 minutes after administration, with nearly 42% reporting pain relief at 30 minutes post-treatment.
Avadir is expected to file a new drug application to the US Food and Drug Administration by early 2014. If approved, this product would be the first and only fast-acting, dry-powder nasal delivery form of sumatriptan.
Migraine is a neurological disease, like epilepsy, and represents an area of significant unmet medical need. Over 37 million Americans suffer from migraine headaches, according to the Centers for Disease Control and Prevention.
Avanir shares rise after hours on license deal (Marketwatch)
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