papapanda schreef op 10 november 2021 10:25:
Paion :
Remimazolam activities in the license territories in the first nine months of 2021
Licensees generated remimazolam revenues totalling EUR 4.4 million in the first nine months of 2021. Based on these, PAION receives royalty payments in varying amounts.
In the U.S., remimazolam (brand name BYFAVOTM) was launched by Acacia for procedural sedation in January 2021. While Acacia has indicated that initial market response was positive, access to clinics and prescribing doctors has been severely limited due to the COVID-19 pandemic. At the end of September 2021, Acacia reported remimazolam to be on track to meet its full year 2021 formulary acceptance goal. By the end of September, remimazolam had been put on formulary in 95 accounts with a >90% win rate; Acacia expects a total of 150 accounts to put remimazolam on formulary by the end of 2021.
For the indication general anesthesia, the license agreement with Cosmo/Acacia originally provided for an option for the U.S. rights to develop and commercialize remimazolam. As this option was not exercised by the licensee, it has lapsed. An advisory meeting was recently held with the FDA (U.S. Food and Drug Administration) on suitability of the European clinical program for filing of a New Drug Application (NDA) in the U.S. As a positive outcome of the Type B meeting, the FDA stated that a submission would be possible with the current data package consisting of European and Asian general anesthesia data. Submission would require a re-analysis of the current data. Alternatively, an additional clinical trial was recommended. PAION will now use the outcome of the meeting to intensify the discussion with interested parties for the general anesthesia license in the U.S.