Avanir Pharmaceuticals has paid $20 million up front to OptiNose for an exclusive North American license for development and commercialization of OptiNose’s intranasal low-dose sumatriptan powder for the treatment of acute migraines. OptiNose could receive an additional $90 million in milestone payments and, if the product is approved, Avanir will make royalty payments on North American sales.
The intranasal dry powder sumatriptan product, currently known as AVP-825, is delivered using OptiNose’s Breath Powered technology with a novel capsule-based device.
Regulatory, manufacturing, and commercialization will be Avanir’s responsibility, and the company says that it expects to file an NDA with the FDA by early 2014. OptiNose will participate in preparation of the application, which is expected to begin immediately.
OptiNose CEO Peter Miller said, “Avanir is an ideal partner given its proven track record of successfully developing and commercializing neuroscience products. The results from our Phase 3 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.”
Avanir Senior VP of Corporate Development and Chief Business Officer Greg Flesher commented, “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.”
Read the Avanir and OptiNose press release.
