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, sublicensed to Acacia Pharma), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS, Turkey and the MENA region (R-Pharm) as well as South Korea and Southeast Asia (Hana Pharm). For all other markets including parts of the EU, remimazolam is available for licensing.

In Japan, remimazolam was approved for general anesthesia in January 2020. In the U.S., a New Drug Application (NDA) for procedural sedation is under review, with a PDUFA date of 5 July 2020. In China, licensee Yichang Humanwell filed for market approval for remimazolam in procedural sedation in November 2018 and in South Korea, licensee Hana Pharm filed for market approval for remimazolam in general anesthesia in December 2019.

In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. Results of a Phase III trial in general anesthesia are expected in the second half of 2020.