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, Turkey and the MENA region (R-Pharm) and South Korea (Hana Pharm). For all other markets outside the EU, remimazolam is available for licensing.

 

The New Drug Application (NDA) in procedural sedation was prepared together with licensee Cosmo Pharmaceuticals (Cosmo) and submitted to the FDA by Cosmo in April 2019. The FDA informed Cosmo in June 2019 that the filing had been accepted and that a target decision date under the Prescription Drug User Fee Act (PDUFA) of 05 April 2020 had been set.

Under this timeline, market approval and subsequent launch is expected in 2020 assuming a regular approval process.

Japanese licensee Mundipharma submitted a market approval dossier for remimazolam for general anesthesia in December 2018, which is currently being assessed by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). Market approval is currently expected early in 2020.

 

Chinese licensee Yichang Humanwell submitted a market approval dossier for remimazolam for procedural sedation to the Chinese National Medical Products Administration (NMPA) in November 2018. Market approval is currently expected in 2020.

 

Russian licensee R-Pharm announced the successful completion of a Phase III trial with remimazolam in general anesthesia in November 2018. R-Pharm is currently preparing to file the marketing dossier in Russia. For the license territory Turkey, Middle East and North Africa, R-Pharm plans to file for market approval based on the U.S. dossier.

 

In Canada, PAION expects its licensee Pharmascience to use the U.S. market approval dossier as the basis for filing for market approval of remimazolam.

 

PAION’s South Korean licensee Hana Pharm successfully completed patient recruitment of a Phase III trial with remimazolam in general anesthesia in October 2018. Hana Pharm is currently preparing to file the marketing dossier in South Korea.