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, England–(BUSINESS WIRE)– FOR TRADE AND BUSINESS MEDIA ONLY

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.”

-Ends-

Notes to editors

About Pharmanovia

Pharmanovia is a global lifecycle management healthcare company. Our purpose is to make medicines fit for tomorrow, to improve the lives of patients globally.

We do this by rediscovering, repurposing or re-engineering established medicines to improve patient outcomes and experiences.

With a diverse and growing team in over 140 countries across the globe, we deliver high-quality solutions, ethically and sustainably, across our four core therapeutic areas – Endocrinology, Neurology, Cardiovascular and Oncology.

About Axsome Therapeutics

Axsome Therapeutics, Inc. is a biopharmaceutical company developing and delivering novel therapies for central nervous system (CNS) conditions that have limited treatment options. Through development of therapeutic options with novel mechanisms of action, it is transforming the approach to treating CNS conditions. Axsome is committed to developing products that meaningfully improve the lives of patients and provide new therapeutic options for physicians.

About Sunosi^® (solriamfetol)

Solriamfetol is the first and only approved, dual-acting dopamine and norepinephrine reuptake inhibitor (DNRI) indicated to improve wakefulness in adult patients with EDS associated with narcolepsy or OSA.

In patients with OSA, both in patients who were adherent to their primary OSA treatment and those who were non-adherent, solriamfetol was shown to:³

• Increase wakefulness in a dose dependent fashion at Week 12, as measured by the MWT
• Decrease sleepiness in a dose dependent fashion at Week 12, as measured by the ESS
• Increase patient reports of feeling better at Week 12, as measured by the PGI-C

Similarly in patients with narcolepsy, solriamfetol was shown to:⁴

• Significantly improve wakefulness as early as week 1, which was maintained through 12 weeks
• At week 12, significantly increased wakefulness as early as 1 hour; with effects maintained through 9 hours post-dose

References

1. https://www.ema.europa.eu/en/medicines/human/EPAR/sunosi – Last accessed 21.2.23
2. PLOS One, 2021, Mandereau-Bruno et al., Obstructive sleep apnea: A sharp increase in the prevalence of patients treated with nasal CPAP over the last decade in France, accessed here: https://uk01.z.antigena.com/l/Cd3ygbEm88lHtCKPjqjPtRfBnH~JIn_BbvAm07Uwym~AKBTOm3hRsjrPhYpYM0phFCee4qPFzoVjIVs90kIsPzSHJ9uftESuHSV3aCzLe2tAH3ffv7tNPypv-58xEo44TdGJzsbyyOVIbGe_rEE18gNNe6_Ey_w~TVB21_BXvr4_2guD6e8ZXw7W24_XBjnMH__
   UpToDate, 2023, Kline, Clinical presentation and diagnosis of obstructive sleep apnea in adults, accessed here: https://www.uptodate.com/contents/clinical-presentation-and-diagnosis-of-obstructive-sleep-apnea-in-adults#:~:text=Global%20estimates%20using%20five%20or,OSA%20also%20varies%20by%20race
   Eurostat, accessed here: https://ec.europa.eu/eurostat/statistics-explained/index.php?title=Population_and_population_change_statistics
   https://www.uptodate.com/contents/clinical-presentation-and-diagnosis-of-obstructive-sleep-apnea-in-adults/print#:~:text=Global%20estimates%20using%20five%20or,OSA%20also%20varies%20by%20race.
3. Schweitzer, PK, et al. Randomized Controlled Trial of Solriamfetol for Excessive Daytime Sleepiness in OSA: An Analysis of Subgroups Adherent or Nonadherent to OSA Treatment. Chest. 2021; 160(1):307-318
4. Thorpy MJ, et al. A randomized study of solriamfetol for excessive sleepiness in narcolepsy. Ann Neurol. 2019; 85(3):359-370. doi: 10.1002/ana.25423

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Contacts

Alison Dyson, Director of Communications, Pharmanovia

07442 256310/ Alison.dyson@pharmanovia.com
Or pharmanovia@67health.co.uk