Avanir inks license agreement with OptiNose

ALISO VIEJO, Calif.—Avanir Pharmaceuticals, Inc. andOptiNose AS have announced the establishment of an exclusive North Americanlicense agreement to develop and commercialize OptiNose's novel Breath Poweredintranasal delivery system containing low-dose sumatriptan powder to treatacute migraine.

Per the terms of the agreement, Avanir paid OptiNose $20million in cash upfront, and OptiNose is also eligible to receive certainshared development costs as well as up to an additional $90 million in clinical,regulatory and commercial milestones. If approved, Avanir will make tieredroyalty payments based on North American net sales as well.

"Avanir is an ideal partner given its proven track record ofsuccessfully developing and commercializing neuroscience products," PeterMiller, CEO of OptiNose, said in a press release about the deal. "The resultsfrom our Phase III clinical study were extremely encouraging and we believe wehave a potential treatment that provides pain relief quickly and with fewadverse events. This new delivery method offers significant benefits and welook forward to working with the Avanir team to bring an important newtreatment option to people who continue to suffer from migraines."

Avanir will be responsible for regulatory, manufacturing,supply-chain and commercialization activities for the product AVP-825, and bothAvanir and OptiNose will collaborate on remaining activities as they move theproduct toward New Drug Application (NDA) submission. Avanir will beginpreparation of the NDA immediately, with the expectation of filing with theU.S. Food and Drug Administration in early 2014.

In a multi-center, randomized, double-blind,placebo-controlled study, patients with migraines were treated in-clinic withsumatriptan 10 mg, sumatriptan 20 mg or placebo administered intranasally witha bi-directional powder delivery device. OptiNose reported that "a greaterproportion of subjects who received sumatriptan were pain-free at 120 minutescompared with those who received placebo," with significant benefits noted forpain relief at 120 minutes and as early as 60 minutes, and for "48 hourssustained pain-free." The nasal administration of sumatriptan was welltolerated, with rare treatment-related adverse events, the most common being a metallictaste.

"The large migraine market is characterized by a high level of dissatisfaction.OptiNose has developed a unique device that has the potential to transform theclinical profile of the leading migraine drug, resulting in a new productcandidate that we believe can significantly improve upon the current treatmentoptions," Greg Flesher, senior vice president of corporate development andchief business officer of Avanir, commented in a statement. "In clinicaltrials, this innovative and easy-to-use device has demonstrated rapidabsorption and migraine relief using approximately 80 percent less drug thanthe most commonly prescribed oral sumatriptan. This NDA-ready asset fits wellwith our current commercial infrastructure and is strategically aligned withstrengthening our position as a leading CNS specialty company."

The Centers for Disease Control and prevention report thatmore than 37 million Americans suffer from migraine headaches, and an onlinesurvey of more than 2,500 frequent migraine sufferers, "Migraine in America2012" by Health Union LLC, reported that 66 percent were disappointed withtheir treatments. Sumatriptan is currently the class leader with a market shareof more than 50 percent, and is the most commonly prescribed migraine drug inthe United States according to IMS NPA.

SOURCE: OptiNose press release