Avanir Pharmaceuticals and OptiNose AS announced that the companies 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 and only fast-acting, dry-powder nasal delivery form of sumatriptan. Under the terms of the agreement, OptiNose received an upfront cash payment of $20M and is eligible to receive certain shared development costs and up to an additional $90M in total linked to the achievement of future clinical, regulatory and commercial milestones. In addition, if approved, Avanir will make tiered royalty payments based on net sales in North America.Under the terms of the agreement, Avanir will assume responsibility for regulatory, manufacturing, supply-chain and commercialization activities for the investigational product, now named AVP-825. Both parties will work together 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 U.S. Food and Drug Administration by early calendar 2014.
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