06.11.2018 12:00:02
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DGAP-News: PAION ANNOUNCES SUCCESSFUL COMPLETION OF RUSSIAN REMIMAZOLAM PHASE III CLINICAL TRIAL BY PARTNER R-PHARM
DGAP-News: PAION AG / Key word(s): Research Update
PAION ANNOUNCES SUCCESSFUL COMPLETION OF RUSSIAN REMIMAZOLAM PHASE III CLINICAL TRIAL BY PARTNER R-PHARM
The Phase III trial was a multicentre, single-blind randomized clinical trial comparing the efficacy and safety of remimazolam and propofol in surgery patients undergoing general anesthesia. The trial was conducted in six medical facilities in Russia and included 150 patients, randomized in two groups, one half was administered with remimazolam, while the other half received propofol. The trial data further confirmed the high safety and efficacy profile of remimazolam. Following this successful completion of the Phase III clinical trial, R-Pharm plans to file for marketing authorization with the Ministry of Healthcare of the Russian Federation in Q1 2019. Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "We congratulate our partner R-Pharm on the successful completion of the Phase III clinical trial in general anesthesia. The study further increases the efficacy and safety database for remimazolam. We now look forward towards filing in the Russian Federation." "We are inspired by the results of this Phase III clinical trial. The research, conducted in Russia, came to the same conclusions as several other international trials. PAION's remimazolam is an anesthetic agent that fully meets all safety and efficacy requirements and standards existing for this type of treatment," Chief Medical Officer of R-Pharm, Mikhail Samsonov, said. About remimazolam PAION has completed clinical development of remimazolam for procedural sedation in the U.S. Currently, an integrated overall analysis of all clinical studies with remimazolam is being conducted in preparation of Cosmo's filing for market approval. After completion of the development for procedural sedation, Cosmo will be responsible for any further development activities in the U.S. The U.S. license partner currently plans to file for market approval in procedural sedation in the fourth quarter 2018/first quarter 2019. A full clinical development program for general anesthesia was completed in Japan, and the remimazolam license partner for this region, Mundipharma, is planning filing for market approval in this indication in Japan in 2018. In Europe, a Phase III study in general anesthesia was started in July 2018 which can be expected to be the only necessary outstanding trial for filing for market approval in the EU based on the Scientific Advice obtained from the EMA in January 2018. Based on the positive results of a Phase II study, ICU sedation beyond 24 hours is another possible attractive indication for further development in the EU by PAION as well as by partners in the licensed territories. Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, South Korea and Japan with Cosmo Pharmaceuticals, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm, and Mundipharma, respectively. For all other markets outside the EU, remimazolam is available for licensing. R-Pharm Contact Disclaimer: This release contains certain forward-looking statements concerning the future business of PAION AG. These forward-looking statements contained herein are based on the current expectations, estimates and projections of PAION AG's management as of the date of this release. They are subject to a number of assumptions and involve known and unknown risks, uncertainties and other factors. Should actual conditions differ from the Company's assumptions, actual results and actions may differ materially from any future results and developments expressed or implied by such forward-looking statements. Considering the risks, uncertainties and other factors involved, recipients should not rely unreasonably upon these forward-looking statements. PAION AG has no obligation to periodically update any such forward-looking statements to reflect future events or developments.
06.11.2018 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. |
Language: | English |
Company: | PAION AG |
Martinstr. 10-12 | |
52062 Aachen | |
Germany | |
Phone: | +49 (0)241-4453-0 |
Fax: | +49 (0)241-4453-100 |
E-mail: | info@paion.com |
Internet: | www.paion.com |
ISIN: | DE000A0B65S3 |
WKN: | A0B65S |
Listed: | Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange |
End of News | DGAP News Service |
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741865 06.11.2018
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