Klaria receives 6.4 MSEK milestone payment from EU’s Horizon 2020 program to take Sumatriptan Alginate Film to market
Today, Klaria Pharma Holding AB (publ) announces that the company has received a milestone payment of 6.4 MSEK from the EU’s Horizon 2020 program. The payment is made as the development of Sumatriptan Alginate film (KL-00119) continues to proceed successfully according to plan. Large-scale production of the product is on-going, and all preparations for the upcoming bioequivalence study are completed. This pivotal clinical study required for submission of approval is planned to start in the first half of 2020 with completion in 2020.
The milestone payment of 6.4 MSEK is expected to cover remaining costs within the KL-00119 project up until filing of applications for market approval. These costs are primarily attributable to continued large-scale production as well as the upcoming bioequivalence study with completion in 2020.
“We have earned this 6.4 MSEK milestone payment by conducting successful development of Sumatriptan Alginate Film in 2019 and the beginning of 2020. The project is proceeding according to plan, and we expect to complete its clinical program in 2020. Thereafter we plan to compile and submit applications for market approval in both the EU and the US during the first half of 2021. Given that the approval process proceeds according to regular timeframes, we can then have a market-approved product that is ready for commercial launch in both the EU and the US in 2022,” says Klaria’s Chief Scientific Officer Scott Boyer.
Klaria’s Chief Executive Officer Jesper Wiklund continues:
“Our successful partnership with the EU Horizon 2020 program continues with this milestone payment. Their support of the development of Sumatriptan Alginate Film is a testament to their conviction that Sumatriptan Alginate Film has the potential to meet the extensive need of new and improved migraine pharmaceuticals in Europe. We are proud to collaborate with the EU Horizon 2020 program and of their strong support to take this project closer to market approval.”
About KL-00119 for migraine-related pain
KL-00119, Klaria’s leading candidate for treatment of acute migraine-related pain, is developed based on the company’s patented drug delivery platform, enabling rapid, comfortable and reliable transport of active substances into the blood stream by attaching a stamp-sized film in the oral mucosa. With these properties, combined with the active substance sumatriptane that has been proven to be effective against migraine-related pain, KL-00119 has great potential to be developed into a competitive product.
About migraine and migraine-related pain
Approximately 12 percent of the world's population is affected by migraines, that often take the form of acute pain episodes. The market for prescription migraine pharmaceuticals is worth 4-5 billion dollars annually, and this number is expected to increase substantially in the future.
For more information, visit the Klaria Pharma Holding website klaria.com or contact:
Jesper Wiklund, CEO Klaria Pharma Holding AB (publ)
investor.relations@klaria.com
Tel: +46 (0) 8-446 42 99
This is Klaria Pharma Holding AB
Klaria (Klaria Pharma Holding AB) is a Swedish listed pharmaceutical company that develops innovative, rapid-acting products. By combining patented technology of a film that attaches to the oral mucosa and well proven pharmaceuticals, the company has developed a drug distribution concept with many benefits and potential uses. Klaria is listed on Nasdaq First North Growth Markets under the short name KLAR. FNCA Sweden is Certified Advisor (info@fnca.se, +46(0) 8-528 00 399) for Klaria Pharma Holding AB. For more information, see www.klaria.com.