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Paion AG. (11/5/12). "Press Release: Paion’s Partner Ono Pharmaceutical Announced Today Initiation of a Phase II/III Study with Short-acting Anaesthetics/Sedative Remimazolam (ONO-2745) in Japan". Aachen.

Region Region Japan
Organisations Organisation Paion UK Ltd.
  Group Paion (Group)
  Organisation 2 Ono Pharmaceutical Co., Ltd. (TSE: 4528)
  Group Ono Pharmaceutical (Group)
Products Product remimazolam (CNS 7056)
  Product 2 clinical research
Index term Index term Ono Pharmaceutical–Paion: remimazolam, 201011 collab existent partnering CNS 7056 for developm in Japan with Ono
Person Person Söhngen, Wolfgang (Paion 200603 CEO)

- Japanese Phase II/III study in general anaesthesia initiated

- The enrolment of the first patient will trigger a milestone payment of three million USD from Ono Pharmaceutical which is expected by the end of this year

- A Phase II study for ICU sedation was also initiated

The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, General Standard: PA8) today announces that its partner, Ono Pharmaceutical Co., Ltd. ('ONO') has initiated a Phase II/III study with Remimazolam for general anaesthesia in September 2012 as the next step after the announcement of a successful completion of a Phase II study in anaesthesia in May 2012. The enrolment of the first patient will trigger a milestone payment of three million USD from ONO which is expected by the end of this year.

The objective of this study is to investigate efficacy and safety of Remimazolam in induction and maintenance of general anaesthesia in a multicenter randomized parallel-group study compared to propofol in surgery patients requiring general anaesthesia.

In addition a Phase II study for ICU sedation was initiated.

ONO entered into the license agreement with PAION UK Ltd. (former CeNeS Limited) in 2007 to develop and commercialize Remimazolam in Japan and is developing the substance for the Japanese market for both 'induction and maintenance of anaesthesia' and 'ICU sedation'.

'Ono having initiated Phase II/III for induction and maintenance of anaesthesia represents a major value inflection point for Remimazolam', commented Dr. Wolfgang Söhngen, CEO of PAION. 'The fact that in parallel ICU sedation is initiated as well highlights the confidence and determination of our partner Ono.'



PAION is headquartered in Aachen, Germany and has a second site in Cambridge, UK. The company is specialised in developing innovative drugs for the hospital-based treatment in indications for which there is a substantial unmet medical need. PAION has extended its 'Search & Develop' business model, by transforming into a 'Specialty Pharma Company', with a focus on anaesthesia products.

About Remimazolam

Remimazolam is an innovative short-acting general anaesthetic/sedative. Due to their short duration of action and good controllability such substances have increased the benefits for patients and the efficacy of the treatment. The rapid offset of the effect of the substance is due to its metabolism by tissue esterase enzymes that are widely distributed throughout the body.

Remimazolam has potential in three indications:

- Procedural sedation (e.g. colonoscopies, Phase IIb completed)

- General anaesthesia (Phase II/III initiated)

- ICU sedation (Phase II initiated)

Remimazolam is available for licensing outside Japan and China, where the compound is partnered with Ono Pharmaceutical and Yichang Humanwell.

Ralf Penner
Director Investor Relations / Public Relations
Martinstrasse 10-12, 52062 Aachen - Germany
Phone +49 241 4453-152


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.

Record changed: 2019-06-09


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