Remimazolam strategy

PAION selectively seeks to enter into development and commercialization collaborations with partners with local expertise or with a specific therapeutic focus with respect to remimazolam. Such collaborations are an effective way of funding and advancing remimazolam’s late-stage 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 collaboration partners 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. PAION’s ultimate goal is to participate in the worldwide commercialization of remimazolam. In order to exploit remimazolam’s full potential, it is PAION’s defined target to commercialize remimazolam on its own in the EU or certain markets in the EU immediately after a potential market approval. PAION is also well positioned to find further collaboration partners. 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., Canada, China, Russia (CIS), Turkey, the MENA region, South Korea and Japan with Cosmo, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm, and Mundipharma, respectively. For all other markets outside the EU, remimazolam is available for licensing.

PAION's license partners are extending the database with clinical studies and are preparing the future filings of remimazolam in their respective territories through regulatory interactions.

Russia: In November 2018, PAION’s license partner R-Pharm announced the successful completion of a Phase III trial in general anesthesia.
R-Pharm plans to file for market approval in the first quarter of 2019.

South Korea: PAION’s license partner 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 needs to be established in South Korea. Accordingly, Hana Pharm plans to file for market approval in 2020.

Other regions: License partners Pharmascience (Canada) and TR-Pharm (Turkey, the Middle East and North Africa) plan to file for market approval in their respective territories based on the U.S. or Japanese dossier.