Klaria currently has a deep patent portfolio to protect the sumatripatan aliginate film, which received market authorization in the EU last year and is currently being prepared for the market in collaboration with Klaria's license partner CNX.

The currently patent protection consists of the `first generation' patent covering the alginate film technology, which is approved in all relevant markets across the world.  The `second generation' patents covering the use of sumatriptan in the film have also been granted in most major markets, including the US, EU, Canada, Australia, New Zealand, South Korea, Israel and Mexico.  The applications in China and Hong Kong are still pending approval.  Together, these markets cover over 95% of the worlds sumatriptan market with very large potential for growth in most markets, which are either underserved with respect to sumatriptan in general, or poorly served by current sumatriptan formulations.

The new application represents the `third generation' of patents protecting the sumatriptan alginate film and represent new discoveries from the most recent years of manufacturing, quality control and testing and promise to, when granted, ensure market exclusivity for the resulting product until at least 2045.  This timeline allows thorough market penetration in all relevant markets, increases the difficulty of market entry of competitors, and increases the overall total lifetime value of the product by adding at least 8 years of market exclusivity.

Migraine is a serious, debilitating condition affecting between 12% and 25% of the population, depending on the region.  Migraine also affects significantly more women than men.  Migraine is also underreported and undertreated, making the potential for an effective preparation like the sumatriptan alginate film ideal for the recommended early intervention in a migraine attack.

Finally, why sumatriptan?  Looking at the outcomes of over 250,000 migraine patients, sumatriptan, alone or in combination with an NSAID, has been shown to be the most effective acute treatment for migraine^1,2 and has been recommended as the most preferred treatment by the American Academy of Family Physicians³.

Against this background, a product offering significant patient advantages like Klaria's sumatriptan alginate film has the potential to make a significant impact on a multibillion dollar, growing worldwide sumatriptan market.

1. Harvard Health Publishing, 2024
2. Neurology, 2023 Dec 12;101(24)
3. Acute Migraine Headache: Treatment Strategies, 2018