Avanir Pharmaceuticals, Inc. (AVNR) recently joined forces with OptiNoseAS for the development and commercialization of AVP-825 for the treatment of acute migraine.
AVP-825 is being developed using OptiNose's novel Breath Powered intranasal delivery system, which includes low dosages of GlaxoSmithKline plc’s (GSK) Imitrex (sumatriptan) for the treatment of acute migraine. Once approved, it will be the first and only fast-acting, dry-powder nasal delivery form of Imitrex.
As per the Centers for Disease Control and Prevention, more than 37 million Americans suffer from migraine headaches.
Under this deal, OptiNose received $20 million from Avanir in the form of an upfront fee. OptiNose could also receive up to $90 million on the achievement of clinical, regulatory and commercialization milestones. Avanir is liable for specific shared development costs. Additionally, Avanir is liable to pay OptiNose tiered royalties after approval, based on North American revenues.
Avanir will be responsible for regulatory, manufacturing, supply-chain and commercialization activities of AVP-825. However, Avanir and OptiNose will jointly work on the remaining activities relating to the regulatory submission of AVP-825. Avanir expects to file a New Drug Application (:NDA) with the US Food and Drug Administration (:FDA) by early 2014.
OptiNose had announced results on AVP-825 from the phase III TARGET study in Nov 2012. In this study, 68% of patients with moderate-to-severe migraines experienced headache relief after two hours. The study also found patients experiencing headache relief as fast as 15 minutes after administration, and around 42% of patients experienced headache relief after 30 minutes of the treatment.
Avanir carries a Zacks Rank #3 (Hold). This deal is a positive for Avanir as it strengthens the company’s pipeline. This deal brings together OptiNose's novel Breath Powered intranasal delivery system and Avanir’s experience in central nervous system (CNS) research, development and commercialization.
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