Avanir Pharmaceuticals, Inc.
) recently joined forces with OptiNoseAS for the development and
commercialization of AVP-825 for the treatment of acute
AVP-825 is being developed using OptiNose's novel Breath
Powered intranasal delivery system, which includes low dosages of
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
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
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.
Currently, companies like
Jazz Pharmaceuticals Public Limited Company
) look well positioned with a Zacks Rank #1 (Strong Buy).
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