DGAP-News: PAION AG / Key word(s): Research Update
PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS PARTNER R-PHARM IN RUSSIA

07.08.2017 / 13:00
The issuer is solely responsible for the content of this announcement.


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.


About remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has already shown positive results in clinical Phase III trials. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary.

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.

Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, and South Korea with Cosmo Pharmaceuticals, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm and Hana Pharm respectively. For all other markets, remimazolam is available for licensing.

About PAION
PAION AG is a publicly listed specialty pharmaceutical company developing and aiming to commercialize innovative drugs to be used in out-patient and hospital-based sedation, anesthesia and critical care services. PAION's lead compound is remimazolam, an intravenous, ultra-short-acting and controllable benzodiazepine sedative/anesthetic drug candidate which is in the final stage of clinical development for use in procedural sedation in the U.S. Currently, PAION is mainly focusing its business and financial resources on successfully completing its ongoing clinical development program in procedural sedation. Outside the U.S., PAION has so far focused on the development of remimazolam in the indication general anesthesia. A full clinical development program for general anesthesia was completed in Japan and PAION is preparing filing in Japan. In the EU, PAION is currently planning to continue the clinical development program. Development of remimazolam in the indication intensive care unit (ICU) sedation is also part of the longer term life-cycle plan for remimazolam.

PAION is headquartered in Aachen (Germany) with a further site in Cambridge (United Kingdom).

PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia.


About R-Pharm
R-Pharm is a Russian private pharmaceutical company founded in 2001 which employs over 3,500 highly qualified specialists in over 60 branches. Turnover reached over RUR 74.5 billion + in 2016. R-Pharm operates in Russia and CIS, the U.S., Germany, Japan, Turkey/MENA and India. The company is involved in R&D, manufacturing, marketing, sales and distribution of innovative pharmaceutical products from a broad number of therapeutic areas in specialty/hospital care. The company has operational GMP-compliant manufacturing sites at Yaroslavl, Kostroma and Novosibirsk (Russia) and Illertissen (Germany). R-Pharm is building a modern Pharmoslavl facility for the synthesis of active pharmaceutical ingredients in Rostov (Russia).
http://r-pharm.com/en/

Contact Information:

For PAION AG:
Ralf Penner
Vice President Investor Relations/Public Relations
Martinstrasse 10-12
52062 Aachen - Germany
Phone +49 241 4453-152
E-mail r.penner@paion.com
www.paion.com
For R-Pharm:
Elena Epifantseva
PR Director
111B, Leninskiy prospect, 119421,
Moscow - Russia
Phone +7 916 862 5057
E-mail epifantseva@rpharm.ru
http://r-pharm.com/en/
 

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.



07.08.2017 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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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

597741  07.08.2017 

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