Remimazolam licensees had product revenues in the amount of EUR 2.7 million in the first half of 2021. Sales of remimazolam in China are growing particularly well and China is currently the largest market globally, whilst in Japan the market is strong, but a previous batch recall and therefore limited supply hindered the sales in market. In the U.S. access to clinics and prescribers has been severely limited in the first half of 2021 by Covid-19 effects on the healthcare system, and PAION is hoping to see growth accelerating in the second half of 2021.
Remimazolam partner activities in the first half-year 2021
In the U.S., the launch of remimazolam (trade name BYFAVOTM) by licensee Acacia Pharma (Acacia) was announced in January 2021. According to Acacia, initial market response was very positive despite the pandemic. At the end of June 2021, Acacia reported BYFAVOTM to be on track to meet its full year 2021 formulary acceptance goals. Until the end of June 2021, BYFAVOTM had been put on formulary in 47 accounts, against an expectation of 150 for the full year 2021; this represents an increase of 40 accounts since March 2021. For the indication general anesthesia, PAION is planning an advisory meeting with the FDA (U.S. Food and Drug Administration) on suitability of the European clinical program for a filing in the U.S. U.S. rights to develop and commercialize remimazolam in general anesthesia were originally subject to an option in the license agreement with Cosmo/Acacia. Since that option was not exercised by PAION’s licensee, it has now lapsed and PAION will intensify discussion with interested parties