Remimazolam strategy

Development and commercialization collaborations with partners with local expertise or with a specific therapeutic focus with respect to remimazolam are an effective way of funding and advancing remimazolam’s development and of assisting PAION with its commercialization in international markets where PAION does not intend to directly conduct sales and marketing activities. PAION expects that the existing licensees will continue the development of remimazolam on the basis of data generated from our U.S., Japanese and European clinical development programs, and subsequently PAION may receive additional data and payments under the existing agreements in the medium to long term. In order to exploit remimazolam’s full potential, it is PAION’s defined target to commercialize remimazolam on its own in selected European markets immediately after a potential market approval. PAION is well positioned to find further licensees. Pharmaceutical companies have a growing need to add drugs to their pipeline that have already demonstrated proof of concept in advanced stages of clinical trials and also provide a commercially viable alternative in a global healthcare environment characterized by increasing cost consciousness.

Remimazolam is partnered in the U.S. (Cosmo Pharmaceuticals), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS (R-Pharm), Turkey and the MENA region (TR-Pharm) and South Korea (Hana Pharm). For all other markets outside the EU, remimazolam is available for licensing.

PAION’s Chinese remimazolam licensee Yichang Humanwell submitted a market approval dossier to the Chinese National Medical Products Administration (NMPA) for remimazolam in the indication procedural sedation in November 2018.

PAION’s Japanese remimazolam licensee Mundipharma submitted a market approval dossier to the Japanese Pharmaceuticals and Medical Devices Agency PMDA for remimazolam in the indication general anesthesia in December 2018.

Together with Cosmo, PAION has prepared the market approval dossier in procedural sedation in the U.S. to a degree that allows for filing for market approval shortly as planned.

In November 2018, PAION’s Russian remimazolam licensee R-Pharm announced the successful completion of a Phase III trial in general anesthesia. R-Pharm currently plans to file for market approval in Russia by the end of 2019.

For Canada, PAION currently expects its remimazolam licensee Pharmascience to use the U.S. market approval dossier as the basis for their own filing for market approval.

PAION’s remimazolam licensee TR-Pharm (Turkey, the Middle East and North Africa) plans to file for market approval in Turkey based on the U.S. or Japanese dossier.

PAION’s remimazolam licensee Hana Pharm has successfully completed patient recruitment of a Phase III trial in general anesthesia in October 2018. Before filing for market approval, the production process for remimazolam needs to be established in South Korea. Accordingly, Hana Pharm plans to file for market approval in 2020.