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 successfully completes patient recruitment of a Phase III trial in general anesthesia
- No safety concerns
Aachen (Germany), 17 May 2018 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that its Russian remimazolam license partner R-Pharm has informed PAION that their Phase III trial in general anesthesia has successfully completed recruitment.
The Phase III study was 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 was recruited in Russia.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "Our collaboration with R-Pharm represents an important pillar of our strategy for the worldwide development of remimazolam. The study will further increase the efficacy and safety database for remimazolam. We are very pleased by our partner's rapid recruitment and are now looking forward towards filing in 2018."
Vasily Ignatiev, CEO of R-Pharm, stated, "Taking into consideration consistent growth in demand for anesthetics with high safety profile, R-Pharm and PAION cooperate intensively in order to introduce new medicine for clinical practice. Phase II and Phase III trials conducted in the United States and Japan show that Remimazolam is efficient as a sedating agent."
The rights to develop and market remimazolam in Russia were granted to R-Pharm in 2013.
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, it is planned to start a Phase III study in general anesthesia in the second half of 2018 which can be expected to be the only necessary outstanding trial for filing for market approval in Europe based on the Scientific Advice obtained from the European Medicines Agency (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.
PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia.
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.
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