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Avanir, OptiNose in Drug Delivery Pact

To use OptiNose delivery system for migraine treatment

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Avanir Pharmaceuticals and OptiNose AS have entered into an exclusive North American license agreement for the development and commercialization of OptiNose’s Breath Powered intranasal delivery system containing sumatriptan powder to treat acute migraine. OptiNose received an upfront cash payment of $20 million and is eligible to receive as much as an additional $90 million in clinical, regulatory and commercial milestones. If approved, OptiNose will also receive royalties on sales.
 
Avanir will assume responsibility for regulatory, manufacturing, supply-chain and commercialization activities and both parties will work together on the remaining activities to support the NDA submission, anticipated by early 2014.
 
“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,” said Greg Flesher, senior vice president of corporate development and chief business officer of Avanir Pharmaceuticals. “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.”
 
“Avanir is an ideal partner given its proven track record of successfully developing and commercializing neuroscience products,” said Peter Miller, chief executive officer of OptiNose. “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. 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.”

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