Avanir Pharmaceuticals and OptiNose have entered into an exclusive North American license agreement for the development and commercialization of OptiNose's novel Breath Powered intranasal delivery system containing low-dose sumatriptan powder to treat acute migraine. If approved, this product would be the first dry-powder nasal delivery form of sumatriptan.
OptiNose received an upfront cash payment of $20 million and is eligible to receive shared development costs and up to an additional $90 million in clinical, regulatory and commercial milestone payments. In addition Avanir will make tiered royalty payments based on net sales in North America.
"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,” said Greg Flesher, senior vice president of corporate development and chief business officer of Avanir Pharmaceuticals. “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."
Avanir will assume responsibility for regulatory, manufacturing, supply-chain and commercialization activities for the investigational product, now named AVP-825. Both companies will work on the remaining activities in support of the NDA submission. Avanir will begin preparing the NDA immediately and expects to file the application with the FDA by 2014.
"The results from our phase III clinical study were extremely encouraging and we believe we have a potential treatment that provides pain relief quickly and with few adverse events,” said Peter Miller, chief executive officer of OptiNose.