PAION was formed in 2000 in Aachen. Since its inception, the founders, Mariola Söhngen, MD and Wolfgang Söhngen, MD focused on the clinical development of CNS compounds.
PAION took over the development of Remimazolam as a pre-IND candidate in 2008 and has successfully developed it to a Phase III compound. Following successful funding activities (EUR 61 million) in 2014, a Phase III program has been initiated in 2015 EU and US global registration. In 2017 the remimazolam Phase III development program in the U.S. in procedural sedation has been completed. First market approval followed in 2020 first in Japan, followed by the U.S. and China.
Until 2008, PAION's focus was on stroke with Desmoteplase for which all remaining rights were sold to Lundbeck in 2012 in order to accelerate the development of Remimazolam.
- First own filing in procedural sedation in the EU
- Submission of new drug application for remimazolam by Cosmo Pharmaceuticals in the U.S.
- 1st filing in general anesthesia in Japan by Mundipharma
- 1st filing in procedural sedation in China by Yichang Humanwell
- Start of Phase III trial in general anesthesia in the EU
- Completion of the remimazolam Phase III development program in the U.S. in procedural sedation
- Cosmo becomes partner for Remimazolam in the U.S.
- Completion of U.S. Phase III colonoscopy trial
- Start of the Remimazolam Phase III programms in procedural sedation in the U.S. and general anesthesia in the EU
- Capital measures of EUR 61 million secured for Remimazolam Phase III programs
- PAION, Inc. founded in the U.S.
- Japanese Phase III program with Remimazolam successfully completed
- Several license agreements with national champions in the anesthesia space (“String of pearls" strategy)
- The sale of all Desmoteplase rights to Lundbeck (EUR 20 million) allows PAION to accelerate the development of Remimazolam
- PAION completes Phase II program in procedural sedation in the U.S.
- PAION acquires CeNeS Pharmaceuticals plc with the candidate compounds Remimazolam, M6G, GGF2
- First Desmoteplase Phase III trial (DIAS 2) fails to meet primary endpoint, PAION identifies suitable patient population and successfully expands partnership with Lundbeck
- PAION AG initial public offering and license agreement for Desmoteplase with Lundbeck
- PAION closes agreement with Forest Inc. for Desmoteplase in the North American markets
- PAION closes third funding round of EUR 8.4 million upon successful completion of Desmoteplase Phase II trial (DIAS 2)
- Start of Desmoteplase Phase II trial in ischemic stroke (DIAS)
- PAION is founded (Founders: Dr. W. Söhngen, Dr. M. Söhngen)
- Desmoteplase in-licensed from Schering AG
- First financing round of EUR 28.6 million