PAION AG
PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS PARTNER R-PHARM IN RUSSIA
DGAP-News: PAION AG / Key word(s): Research Update PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS PARTNER R-PHARM IN RUSSIA – R-Pharm has started a Phase III trial in general anesthesia – Remimazolam administered to first patient in August 2017 Aachen (Germany), 07 August 2017 – The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its Russian remimazolam licensing partner R-Pharm has informed PAION that their first Phase III trial in general anesthesia has started recruitment. The Phase III is a multicentre, single-blind randomized comparative clinical trial of efficacy and safety of remimazolam and propofol in 150 surgery patients undergoing general anesthesia. The trial will be recruited in Russia. Dr. Wolfgang Söhngen, CEO of PAION AG, commented: “This is great news for PAION. We are delighted by the strong commitment to remimazolam by our Russian partner R-Pharm. We look forward to learn more about the progress in Russia.” Vasily Ignatiev, CEO of R-Pharm, stated, “We have high expectation for the forthcoming results of the Phase III trial in Russia. Most certainly these results will once again demonstrate the efficiency and high safety profile of remimazolam. We strongly believe that our partnership with PAION, a true PAIONeer in anesthesia and sedation, which is documented by the positive data in both areas where there is great medical need, will be fruitful and longstanding.” The rights to develop and market remimazolam in Russia were granted to R-Pharm in 2013. Through further license agreements signed in 2013 and 2014 with the R-Pharm affiliate TR-Pharm, based in Istanbul, they will also manage the development and marketing approval process in Turkey and the MENA region.
During clinical studies, remimazolam demonstrated efficacy and safety in over 1,500 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile. Remimazolam is currently in the final stage of clinical development for procedural sedation in the U.S. After completion of the ongoing development, the implementation of a pediatric development plan already agreed with the FDA is planned. A full clinical development program for general anesthesia was completed in Japan, and a Phase II study in general anesthesia was completed in the EU. Based on the positive results of the Phase II study, development for ICU sedation beyond 24 hours is another attractive indication. About PAION PAION’s vision is to become an acknowledged “PAIONeer” in sedation and anesthesia.
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07.08.2017 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 |
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