US-based Axsome Therapeutics has entered into an exclusive license agreement with Pharmanovia to further develop and market Sunosi (solriamfetol), a medicine used to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea, in Europe and certain countries in the Middle East and North Africa (MENA).

Pharmanovia, a global pharmaceutical company that revitalizes, extends, and expands the lifecycle of already-established medicines, will handle local clinical and regulatory activities and be responsible for all ongoing and future clinical studies in Europe and MENA, per the agreement. Axsome will receive an upfront payment of $66 million and is eligible to receive sales-based and other milestones totaling up to $101 million. 

“We are pleased to collaborate with Pharmanovia, a company which shares our excitement and commitment to maximize the potential of Sunosi for patients worldwide,” says Herriot Tabuteau, MD, CEO of Axsome, in a press release. “Pharmanovia’s strong commercial platform is well suited to expand the availability of and access for this important treatment across Europe and MENA.”

Axsome acquired Sunosi from Jazz Pharmaceuticals last May. Sunosi received US Food and Drug Administration approval on March 20, 2019, and was designated a Schedule IV medicine by the US Drug Enforcement Agency on June 17, 2019.

Sunosi was approved by the European Medicines Agency in 2020 based on data from randomized placebo-controlled studies in patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea that demonstrated the superiority of Sunosi relative to placebo.

According to Pharmanovia CEO James Burt in a press release, a phase 3 study and longer-term extension study exploring the safety and effectiveness of Sunosi in children with narcolepsy will be initiated by Pharmanovia with the aim of bringing the therapy to young people affected by the disease.

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