Avanir Pharmaceuticals and OptiNose Announce Development and Commercialization Agreement for a New Fast-Acting Investigational Product for the... Pharmaceutical Companies
Avanir Pharmaceuticals and OptiNose Announce Development and Commercialization Agreement for a New Fast-Acting Investigational Product for the Treatment of Acute Migraine
By a News Reporter-Staff News Editor at Clinical Trials Week -- Avanir Pharmaceuticals, Inc. (NASDAQ: AVNR) and OptiNose AS announced that the companies have entered into an exclusive North American license agreement for the development and commercialization of OptiNose's novel Breath Powered intranasal delivery system containing low-dose sumatriptan powder to treat acute migraine. If approved, this product would be the first and only fast-acting, dry-powder nasal delivery form of sumatriptan (see also Pharmaceutical Companies).
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 total linked to the achievement of future clinical, regulatory and commercial milestones. In addition, if approved, Avanir will make tiered royalty payments based on net sales in North America.
"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," said Greg Flesher, senior vice president of corporate development and chief business officer of Avanir Pharmaceuticals. "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."
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 in support of the NDA submission. Avanir will begin preparing the NDA immediately and expects to file the application with the U.S. Food and Drug Administration by early calendar 2014.
"Avanir is an ideal partner given its proven track record of successfully developing and commercializing neuroscience products," said Peter Miller, chief executive officer of OptiNose. "The results from our phase III 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."
Migraine represents an area of significant unmet medical need. According to the Centers for Disease Control and Prevention, over 37 million Americans suffer from migraine headaches.(1) The triptan class of medications is generally considered the gold standard of care with over 13 million prescriptions written annually. Sumatriptan is the class leader with a market share of over 50% making it the most commonly prescribed migraine drug in the U.S.(2) An online survey of over 2,500 frequent migraine sufferers revealed that 66% were dissatisfied with their treatments.(3) As a result, many migraine sufferers are seeking fast-acting, well tolerated treatment options.
Keywords for this news article include: Pharmaceutical Companies, Therapy, Neurology, Treatment, OptiNose Us Inc., Adverse Drug Reaction, Headache and Migraine, Clinical Trials and Studies.
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