PHARMANOVIA ENTERS IN-LICENSING AGREEMENT WITH AXSOME THERAPEUTICS TO MARKET AND FURTHER DEVELOP SUNOSI® (SOLRIAMFETOL), A FIRST-IN-CLASS TREATMENT FOR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEOPLE WITH NARCOLEPSY AND OBSTRUCTIVE SLEEP APNOEA

PHARMANOVIA ENTERS IN-LICENSING AGREEMENT WITH AXSOME THERAPEUTICS TO MARKET AND FURTHER DEVELOP SUNOSI® (SOLRIAMFETOL), A FIRST-IN-CLASS TREATMENT FOR EXCESSIVE DAYTIME SLEEPINESS (EDS) IN PEOPLE WITH NARCOLEPSY AND OBSTRUCTIVE SLEEP APNOEA

• THE AGREEMENT COVERS ALL EXISTING TERRITORIES IN EUROPE AND ANY FUTURE LAUNCHES ACROSS THE REGION
• PHARMANOVIA WILL ALSO LEAD ALL ACTIVITIES TO SUPPORT THE LAUNCH OF SUNOSI® (SOLRIAMFETOL) ACROSS MIDDLE EAST & NORTH AFRICA (MENA)
• PHARMANOVIA IS RESPONSIBLE FOR ALL ONGOING AND FUTURE CLINICAL STUDIES IN EUROPE AND MENA

BASILDON, UK, 22 February 2023

Pharmanovia, a global pharmaceutical company that revitalises, extends and expands the lifecycle of already established medicines, has today announced the expansion of its neurology portfolio through a new licensing agreement with US-based biopharmaceutical company, Axsome Therapeutics, Inc.

The agreement gives Pharmanovia the exclusive marketing rights to Sunosi® (solriamfetol), a first in class medicine used to improve wakefulness and reduce excessive daytime sleepiness (EDS) in adults with narcolepsy or obstructive sleep apnoea (OSA)¹, in Europe and MENA regions. Pharmanovia will continue researching solriamfetol’s potential in children. A pivotal Phase III study and longer-term extension study, exploring the safety and effectiveness of solriamfetol in children with narcolepsy, will be initiated by Pharmanovia, with the aim of bringing this breakthrough therapy to young people affected by this debilitating disease. The agreement also allows Pharmanovia to explore solriamfetol’s potential in other neurological conditions, such as attention deficit hyperactivity disorder (ADHD).

Global estimates using five or more events per hour suggest rates of 936 million people worldwide with mild to severe OSA, and 425 million people worldwide with moderate to severe OSA, between the ages of 30 and 69 years of age.² EDS can have a huge impact on an individual’s quality of life and ability to function day to day, with common signs and symptoms including brain fog, frequent tiredness and unrefreshing sleep.

Pharmanovia CEO, James Burt commented; “We are delighted to have been recognised by Axsome as the right overseas partner both for the expansion in Europe and in bringing this important medicine to MENA. In addition to our focus on lifecycle management of iconic brands, a key pillar of our strategy is to utilise our extensive technical and commercial platform to bring novel, complementary medicines to patients in the therapeutic settings we support. In-licensing a novel, first-in-class neurological medicine is a great demonstration of delivering on this strategy.  

“We’re especially excited to initiate the paediatric trials in narcolepsy. Clinical research in children is inherently more sensitive and, as a result, there are countless medical interventions with the potential to bring life-changing benefits to young people that have simply not been tested and, therefore, cannot currently be used.”

Dr. Herriot Tabuteau, CEO of Axsome Therapeutics, added: “Solriamfetol is an important medicine with demonstrated clinically meaningful efficacy and a unique mechanism of action. This partnership builds on Pharmanovia’s established neurology footprint across Europe and MENA and facilitates solriamfetol reaching as many patients that could benefit from it as possible. Partnering with Pharmanovia is a natural choice for us, given their alignment with us on the value that solriamfetol presents and their plans to expand access.”