Klaria signs license agreement for Sumatriptan Alginate film in Europe with CNX Therapeutics
Klaria Pharma Holding AB (publ) ("Klaria" or the "Company") announces that the Company has signed a license agreement for Sumatriptan Alginate Film (the "Product"), a pharmaceutical product based on Klaria's patented alginate films for fast and reliable administration via the oral mucosa, which is approved in Germany, Spain and Italy for the treatment of migraine with or without aura, with CNX Therapeutics Limited (“CNX Therapeutics”). The agreement gives CNX Therapeutics the right to market and sell the Product in Europe and the UK under its own brand and product name, and the parties plan an initial launch in Germany, Spain and Italy in the second half of 2025 with further expansion in 2026. The agreement gives Klaria an up-front payment of EUR750,000, milestone payments of approx. EUR500,000 – 1,250,00 based on pricing per geographic market for the first 8 countries, as well as a double-digit royalty based on sales revenue. Furthermore, negotiable milestone payments are possible when expanding the market territory within the EEA. In addition to the license agreement, Klaria has a long-term business relationship with AdhexPharma SAS, a leading CDMO located in France and Germany, as the parties’ production partner. Today, AdhexPharma has an annual production capacity of 200 million units, with plans to scale up to meet market demand for Sumatriptan Alginate Film.
Sumatriptan Alginate Film is Klaria's leading project developed with the support of the EU Horizon2020 program. The product received market approval for the leading European markets Germany, Spain and Italy in August of 2024. Expansion of the authorization to other markets in Europe through the Mutual Recognition Process (MRP) will commence in 2025.
The license agreement represents a decisive milestone for Klaria. The Company is now in an exclusive group of Swedish biotechnology and pharmaceutical companies that have succeeded in developing a pharmaceutical product all the way from invention to use in patients.
Klaria's Board Chairman Fredrik Hübinette, who is also the inventor of the Company's alginate film technology said:
“The entire Klaria team is incredibly proud to sign this license agreement with CNX Therapeutics. We see CNX Therapeutics as a perfect partner to bring Sumatriptan Alginate Film to market and ensure it reaches those migraine sufferers who are looking for a more reliable and effective solution than tablets, nasal spray, or injection. This agreement for Europe is also expected to facilitate negotiations to sign a corresponding agreement with a suitable counterpart for the US and other markets.”
Ben Moore, Vice President of Corporate Development at CNX Therapeutics, said: "We are excited to add Sumatriptan Alginate Film to our growing CNS portfolio. This product provides a significant advantage for patients and aligns perfectly with our strategy of expanding access to innovative treatments across Europe. Our partnership with Klaria continues to reflect our commitment to delivering high-quality medicines that improve patient outcomes."
Summary of the terms of the license agreement
The license agreement covers all geographic markets within the EEA, UK and Switzerland. Klaria's compensation according to the agreement consists of three parts: up-front payment, milestone payments and royalties on sales revenue.
The up-front payment amounts to EUR750,000 and is received by Klaria in connection with the signing of the license agreement.
Milestone payments are paid for each individual country market in connection with the pricing of the Product being determined for that individual market. Milestone payments for the first eight markets is approximately EUR 500,000 – 1,250,000. Klaria and CNX Therapeutics expect that the pricing of the Product will be determined for the first three geographic markets in Europe (Germany, Spain and Italy) during the first half of 2025.
When launching on more markets than the first eight within the EEC, negotiable milestone payments will be paid out as well as royalties according to the agreement.
The established royalty amounts to a double-digit market percentage of the sales revenue for the Product. Klaria expects that royalties can begin to be received in the second half of 2025 for the first three geographic markets.
Sumatriptan Alginate Film: Distinct advantages in a very large market
Migraine is a very common medical condition and is classified as a national disease and affects an estimated 12-15% of the world's population, both adults and children. In Europe, around 2 million people suffer from migraine attacks every day. Migraine is thus a very common disease, and in Sweden alone around 1.3 million people are affected. An average frequency of 1.3 migraine attacks per month means that the Swedish population has around 17 million migraine attacks per year. Of the roughly one million Swedes who have migraines, around 400,000 are severely affected with frequent migraine attacks, which means four or more attacks per month. Across Europe, a conservative estimate of migraine patients is approximately 30million.
There is no curative treatment, and migraine attacks often come suddenly, which means that patients need to intervene in their attack early in its development. Triptans in general and sumatriptan in particular are the leading symptom-relieving active medications1. Sumatriptan alone has a world market worth approximately SEK28 billion per year2. The sumatriptan market is estimated to grow by 8-10% per year until 2031.
Until now, sumatriptan administration takes place in tablet form, as a nasal spray or as an injection. Many migraine patients become nauseous or suffer from vomiting, which means that both tablets and nasal sprays can be difficult to use. At the same time, many patients find that injection products are unpleasant and/or bulky to always carry with them.
Sumatriptan Alginate Film is a unique product as it has been demonstrated to be bioequivalent to the nasal spray, while the postage stamp-sized film is fixed to the oral mucosa and providing a reliable dose every time. The product has proven in clinical studies to have the potential for much improved better effect profile and significantly lower variability than the nasal spray, potentially giving more repeatable and longer-lasting pain relief. This means that patients have a greater opportunity for successful treatment compared to other products. These distinct benefits are something that many migraine patients and their doctors are asking for.
Given the Product's distinct advantages, the Company estimates that its market potential in Europe amounts to 10-30% (700-2,100 MSEK) of the existing market for nasal sprays and injections, as well as 10% of the market for tablets. This estimate is supported by a market report that Klaria received from the market analysis group L.E.K.
About CNX Therapeutics
CNX Therapeutics is a speciality pharmaceutical company committed to improving the lives of patients by providing access to essential medicines. CNX commercialises and distributes a portfolio of pharmaceuticals for neurological, psychiatric and hospital emergencies in over 60 markets worldwide, both directly and through strategic partnerships, and is an attractive partner for companies who are looking for a pan-European partner for Central Nervous System (CNS) and hospital injectable products, which is committed to the highest standards of ethics and sustainability. For more information, visit: www.cnx-therapeutics.com
About Klaria Pharma Holding AB
Klaria (Klaria Pharma Holding AB) is a Swedish listed pharmaceutical company that develops innovative, fast-acting products. By combining a patented technology – a film that adheres to the oral mucosa – with well-proven substances, the company has developed a concept for drug distribution with many advantages and potential uses. Klaria is listed on the First North Growth Market under the short name KLAR. FNCA Sweden is Certified Advisor (info@fnca.se, 08-528 00 399) for Klaria Pharma Holding AB.
Advisor
Ernst and Young, Stockholm has acted as advisor on Klaria's behalf throughout the transaction process.
EU Horizon 2020 Support
Klaria acknowledges the support of the EU Horizon 2020 program for its financial support of the development of this product under Grant Number 829615.
1Harvard Health, 05 Feb 2024: https://www.health.harvard.edu/blog/which-migraine-medications-are-most-helpful-202402053014
2Europe Sumatriptan Succinate Market Report 2024, Cognitive Market Research: https://www.cognitivemarketresearch.com/regional-analysis/europe-sumatriptan-succinate-market-report?srsltid=AfmBOoqkczXNRcAqUAaJ-RxBYEspu100JX7iIYioXUyYV6NIsEEWpUja
For more information, visit Klaria Pharma Holding's website klaria.com or contact:
Fredrik Hübinette, Chairman of the Board, Klaria Pharma Holding AB (publ)
investor.relations@klaria.com
Phone: +46 733 44 66 09
This information is information that Klaria Pharma Holding AB is obliged to make public according to the EU’s market abuse regulation (EU no. 596/2014). The information was submitted, through the provision of the specified contact person, for publication on 2025-01-10 19:00 CET.