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
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.”
Notes to editors
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
- https://www.ema.europa.eu/en/medicines/human/EPAR/sunosi - Last accessed 21.2.23
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
- 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
- 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
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20230222005717/en/
Alison Dyson, Director of Communications, Pharmanovia
07442 256310/ Alison.email@example.com
About Business Wire
For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Great Hill Partners Expands Presence Internationally with Opening of London Office20.3.2023 12:00:00 EET | Press release
Great Hill Partners, a private equity firm that invests in high-growth, disruptive companies, today announced that the firm has opened a London office to support its strong historical track record of investment activity in the UK and Europe. The London office will serve as Great Hill’s regional hub for the UK and Europe, providing the firm with a dedicated local presence, greater access to investment opportunities, and resources for portfolio companies. Longtime Great Hill Managing Director Drew Loucks will lead the new office and grow the London team. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230320005225/en/ (Photo: Business Wire) “Opening a London office is a natural next step for Great Hill," said Chris Gaffney, Managing Director at Great Hill. “We have more than a decade of experience investing in the UK and Europe, with a large and growing portfolio of international investments. The launch of a London office provi
Cirium Launches the First Airline Routes Tool Based on Satellite-Based Flight Tracking20.3.2023 11:00:00 EET | Press release
Cirium, the aviation analytics leader, has launched the aviation industry’s first Airline Routes tool to identify actual flights flown by aircraft type. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230320005187/en/ Cirium's Airline Routes tool analyzes an airline's routes using satellite-based flight tracking data to identify actual flights flown by aircraft type. (Photo: Business Wire) It uses applied analytics to derive routes flown by airlines based on satellite-based flight tracking and fuses this with advanced fleet data. The new premium Routes tool is part of Ascend Profiles, a visual descriptive analytics tool which enables businesses to quickly view aircraft intelligence by airline or lessor. Businesses such as aircraft lessors, banks or aircraft manufacturers are empowered to identify the aircraft flown by route for 1,700 airlines and factor development opportunities or risk into their decision making. By leveragi
2023 Harbin Ice & Snow Expo Was Successfully Held on March 17-1920.3.2023 10:55:00 EET | Press release
The 2023 Harbin Ice & Snow Expo, themed on "seeking development in the new paradigm and promoting the revitalization with ice and snow economy", was successfully held from 17 to 19 March in Harbin. It was hosted by Harbin Municipal People's Government, co-organized by CCPIT Harbin Committee and Beijing Zhenwei Exhibition Co., Ltd., and supported by Harbin Municipal Bureau of Culture, Radio, Television and Tourism. The Expo boasted a total exhibition area of 23,800 sqm, with 14 theme exhibition areas and nine international pavilions. Over 500 exhibitors in the ice-snow industry from 19 countries and regions, such as China, Canada, Iceland, France, Russia, Spain, etc., attended the event on online and offline platforms. Decathlon, POMA, Sany, XCMG, X-bionic, SUNAC SNOW PARK, HEILONG, Q.M.XUE LONG, Bombardier, Haxinlong Machinery, Fenlan Xuedong, Zhongcheng Technology, IWEIER STAR TECHNOLOGY, Ding Hongxin Sports Technology, TERROR, ADVANTURER and others showcased over 3,000 ice-snow exhib
Blackstone Announces Opening of New Office in Frankfurt, Germany20.3.2023 10:46:00 EET | Press release
Blackstone (NYSE: BX), the world’s largest alternative asset manager, today announced that it will open a new office in Frankfurt, Germany. The new flagship location will occupy 1,300 square meters in the OMNITURM in Frankfurt’s financial district and serve as a hub for Blackstone in Germany. The new office will host professionals across Blackstone’s private equity, real estate, and credit businesses, in addition to providing a hub for Blackstone’s private wealth solutions business, which serves investment professionals and individual investors across Europe. Juergen Pinker, Senior Managing Director, will lead on Private Equity, with Jurij Puth, Senior Managing Director, leading on Credit. Blackstone has been an active and significant investor in Germany for more than two decades, with currently more than 7,000 people employed by its portfolio companies in the country. To date, the firm has been involved in transactions worth more than €17 billion in Germany. The opening of the new off
Guardforce Security Adopts Hytera Push-to-talk to Improve Operational Efficiency20.3.2023 05:00:00 EET | Press release
Hytera Communications (SZSE: 002583), a leading global provider of professional communications technologies and solutions, has been providing Guardforce Security Thailand with its newest Push-to-Talk over Cellular (PoC) radios and Hytera HyTalk software suite to facilitate nationwide instant group communications and better team collaboration among Guardforce staff. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20230314006104/en/ Guardforce security personnel on duty with Hytera PoC radios (Photo: Business Wire) Guardforce Thailand is a major security company that supplies technology-driven security solutions to a wide range of clients across Thailand, including banks, government organizations, retailers, shopping malls, hotels, airports, and enterprises. It currently employs approximately 5,000 security personnel nationwide across its three divisions. The security provider used to rely on analog two-way radios for communicati
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.Visit our pressroom