Avanir, OptiNose Enter Exclusive North America License Deal

Avanir Pharmaceuticals Inc. (AVNR) and OptiNose AS reached an exclusive North American licensing deal to develop OptiNose’s Breath Powered system, a potential treatment for acute migraines.

The companies claim that, if approved, the product would be the first and only fast-acting, dry-powder nasal delivery of migraine headache drug sumatriptan.

Under the terms of the agreement, OptiNose received an upfront cash payment of $20 million and is eligible to receive certain shared development costs and up to an additional $90 million in milestone payments. Also, if approved, Avanir will make tiered royalty payments based on 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 to support the new drug application submission to the U.S. Food and Drug Administration. Avanir said it will begin preparing that application immediately and expects to file it by early 2014.

In November 2012, OptiNose reported results from its Phase 3 study in 212 subjects. The study found that OptiNose’s Breath Powered product provided headache relief for 68% of subjects with moderate to severe migraines after two hours, with some subjects experiences headache relief as quickly as 15 minutes.

There were no serious adverse events associated with the product in the study, the companies reported.

Additionally, Avanir plans to enter into a debt financing. The $50 million term loan would be used to retire Avanir’s current $30 million term loan and pay the upfront $20 million payment to OptiNose.

Shares of Avanir were up one cent after hours at $4.55. As of Tuesday’s close, the stock was up 74% so far this year.