A breath of fresh money for migraine treatment

OptiNose signed a licensing deal worth up to $110 million for its experimental migraine headache treatment. OptiNose signed a licensing deal worth up to $110 million for its experimental migraine headache treatment.  The treatment, in late-stage testing, uses the Bucks County medical device company’s Breath Powered intranasal drug-delivery system.

The agreement was signed with Avanir Pharmaceuticals (NASDAQ: AVNR), a specialty pharmaceutical company focused on developing new treatments for central nervous system disorders.

In return from giving Avanir an exclusive North American license for its migraine treatment, OptiNose will receive a $20 million upfront payment plus another $90 million based on the product meeting regulatory milestones and sales targets. It will also get undisclosed royalty payments if the product is approved.

“This is an important deal for us because it means a third party has validated our technology,” said Peter Miller, the CEO of OptiNose.

OptiNose has developed what it describes as bi-directional nasal technology it is applying to existing therapies to make them more effective. The technology was invented by Dr. Per Djupesland, an ear, nose and throat specialist from Oslo. It uses the natural flow of a patient’s breath to propel medications into the nasal cavity. More details on how the system works, including video of the technology in action, is available here.

Miller said the company’s technology provides a way for a drug to be absorbed into the blood stream more rapidly than pills or patches.

The deal with Avanir covers the use of the Breath Powered system to deliver a low-dose sumatriptan powder to migraine patients.

“The migraine market is characterized by a high level of dissatisfaction [among patients seeking treatment],” said Greg Flesher, senior vice president of corporate development and chief business officer at Avanir. “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.”

Under the agreement, Avanir will assume responsibility for regulatory, manufacturing, supply-chain and commercialization activities for the experimental product, now named AVP-825. Avanir expects to file a new drug candidate for the product early next year.

OptiNose is also testing the use of its technology to improve the delivery of two other medicines — one for treating nasal polyps and the other for autism spectrum disorders.

Miller, a former Johnson & Johnson (NYSE: JNJ) executive who previously co-founded and served as CEO of Take Care Health in Conshohocken, said the company was looking to license its migraine treatment to a mid-sized pharmaceutical company. He didn’t want to see the treatment get lost among the long list of products marketed by a larger pharmaceutical manufacturer.

“I like doing things in a non-conventional manner,” Miller told me. “In my view we are much better off with this company. They are going to be highly motivated to make our product a success.”

Avanir of Aliso Viejo, Calif., has one product, Nuedexta, in the market. Nuedexta is a treatment of pseudobulbar affect, a condition which occurs secondary to a variety of unrelated neurological conditions and is characterized by involuntary, sudden, and frequent episodes of laughing and/or crying.

Miller said he approached people he knows at Avanir from his days at Johnson & Johnson to talk about a potential licensing deal for OptiNose’s migraine treatment.

“They were interested,” he said. “They were looking for another product to put in their bag.”

OptiNose was founded in Norway in 2000. The company moved to Yardley in 2000 when Miller was brought in as CEO. The company, which outsources most its product manufacturing and testing activities, has 22 employees.

“We believe the right way to operate the company is lean and mean,” Miller said.

Among its competitors is NuPathe, a Conshohocken biopharmaceutical company that expects to launch its migraine drug Zecuity — a transdermal patch containing sumatriptan — by the end of this year.