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news.Avanir Pharmaceuticals and OptiNose have signed a license agreement in North America to develop and commercialise a new fast-acting investigational product, Breath Powered intranasal delivery system containing low-dose sumatriptan powder, for the treatment of acute migraine.
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According to the deal, Avanir will be responsible for the regulatory, manufacturing, supply-chain and commercialisation activities of the product, named AVP-825, while both the companies will work on the remaining activities related to NDA submission.
The NDA filing with the US Food and Drug Administration is expected by 2014 and if approved, the product would become the first and only fast-acting, dry-powder nasal delivery form of sumatriptan.
Avanir corporate development senior vice president and chief business officer Greg Flesher said, "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.
OptiNose earned upfront cash payment of $20m and is eligible for certain shared development costs and up to an extra $90m in total for potential clinical, regulatory and commercial milestones.
Once approved, tiered royalty payments based on net sales in North America will be made by Avanir.
OptiNose chief executive officer Peter Miller said, "This new delivery method offers significant benefits and we look forward to working with the Avanir team to bring an important new treatment option to people who continue to suffer from migraines."