DGAP-News: PAION AG
/ Key word(s): Miscellaneous
PAION GRANTS EXCLUSIVE LICENSE TO TTY BIOPHARM FOR DEVELOPMENT AND COMMERCIALIZATION OF REMIMAZOLAM IN TAIWAN
- EUR 1.1 million upfront payment to PAION
- Supply of drug product at a percentage of net selling price
Aachen (Germany), 05 March 2021 - PAION AG, a specialty pharma company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8), and TTY Biopharm Company Limited ("TTY") today announce that they have entered into a license agreement for remimazolam with PAION granting TTY an exclusive license for the development and commercialization of PAION's lead drug candidate, remimazolam, in Taiwan.
Under the terms of the agreement, TTY has the right and obligation to further develop remimazolam in all indications in Taiwan with PAION's support. TTY will bear all cost for market authorization and distribution.
PAION will receive a EUR 1.1 million upfront payment and will supply drug product at a percentage of the net selling price in Taiwan with minimum supply price guarantees.
Dr. Jim Phillips, CEO of PAION AG, commented: "We are excited to have TTY as our partner for remimazolam in Taiwan. They have an impressive track record in the Taiwanese pharmaceutical market with a growing and successful presence in the hospital setting, especially critical care. We look forward to collaborating to make the regulatory filing, approvals and market launch in the coming months."
Remimazolam is approved in the U.S. and China for procedural sedation and in Japan and South Korea for general anesthesia. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019.
In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.
Remimazolam is partnered in the U.S. (brand name BYFAVOTM) with Acacia Pharma, in Japan (brand name Anerem(R)) with Mundipharma, in China (brand name Ruima(R)) with Yichang Humanwell, in Canada with Pharmascience, in Russia/CIS, Turkey and the MENA region with R-Pharm, in South Korea (brand name BYFAVOTM) and Southeast Asia with Hana Pharm and in Taiwan with TTY Biopharm. For all other markets excluding parts of Europe, remimazolam is available for licensing.
About TTY Biopharm
In Europe, PAION is seeking approval of Byfavo(R) (remimazolam) for general anesthesia and for procedural sedation. In January 2021, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended approval of Byfavo(R) in procedural sedation. It is planned to commercialize Byfavo(R) once approved in Europe together with GIAPREZA(TM), a vasoconstrictor indicated for the treatment of refractory hypotension in adults with septic or other distributive shock who remain hypotensive despite adequate volume restitution and application of catecholamines and other available vasopressor therapies, and XERAVA(TM) for the treatment of complicated intra-abdominal infections in adults.
PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors and other stakeholders in healthcare.
PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).
05.03.2021 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
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