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Paion AG. (5/14/12). "Press Release: Results of Phase II Study of Remimazolam (ONO-2745/CNS 7056), a Short-acting General Anesthetic". Aachen.

Region Region Japan
Organisations Organisation Paion AG
  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
Persons Person Söhngen, Mariola (Convert Pharmaceuticals 201811– CEO before Mologen + Paion)
  Person 2 Penner, Ralf (Paion 201011 Director Investor/Public Relations)
     


PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange General Standard: PA8) today announced that its Japanese development partner, Ono Pharmaceutical Co., Ltd. ('Ono') has informed PAION AG, that it has completed a phase II clinical study of Remimazolam (development codes: ONO-2745/CNS 7056), which has been developed by PAION and now its development in Japan is promoted by ONO for general anesthesia. The outline of the study results are shown below.

This study was conducted in Japan as an open-label study in surgery patients undergoing general anesthesia in combination with analgesics. Remimazolam was intravenously administered to 85 surgery patients 20 years or older, with the purpose of induction of general anesthesia for 45 patients, and induction and maintenance of general anesthesia for 40 patients.

All 43 patients analyzed among the patients who received Remimazolam for induction of general anesthesia achieved loss of consciousness and underwent successful intubation, while all 32 patients analyzed among the patients who received Remimazolam for induction and maintenance of general anesthesia achieved loss of consciousness and underwent successful intubation with successful completion of a surgery without need of rescue therapy for sedative effects.

No adverse events of concern were observed. As expected in 98.8% of patients adverse events were observed due to the nature of the intervention (surgery), including primarily wound complication, laboratory test abnormal, and blood pressure decreased, which correspond with relatively common events typically observed in perioperative patients. There is no concern on safety.

ONO entered into a license agreement with PAION in August 2007, acquiring the exclusive rights to develop and market Remimazolam in Japan.

Dr. Mariola Söhngen, the Chief Medical Officer at PAION states: 'We congratulate our partner ONO on the successful completion of the Phase II study in anaesthesia, which could also support an accelerated development of this indication in other territories. The data generated by Ono will be an important contribution to the overall safety and efficacy database on Remimazolam. We look forward to the further development of Remimazolam through our partner Ono Pharmaceutical. '

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About PAION

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 is extending its 'Search & Develop' business model, by transforming into a 'Specialty Pharma Company', with a focus on anaesthesia products.


About Ono

In keeping with its philosophy of 'Dedicated to Man's Fight against Disease and Pain' Ono has always striven to achieve its goal of serving as an R&D-oriented global speciality pharmaceuticals, aiming to develop innovative and globally recognized drugs.

Ono offers a number of drugs in disease area where we have high medical needs including a new class of drug for type II diabetes (Glactiv(R) Tablet) and chemotherapy-induced nausea and vomiting (Emend(R) Capsule, Proemend(R) for intravenous infusion) and a transdermal drug for Alzheimer's disease (Rivastach(R) Patch).


About Remimazolam

Remimazolam is an innovative short-acting general anaesthetic/sedative. Sedatives are used, for example, in endoscopic procedures such as colonoscopies. After intravenous administration Remimazolam rapidly induces the desired sedation. Importantly, this sedative effect quickly disappears. This 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 is being developed as a sedative agent for day case procedures (procedural sedation) as well as for the induction and maintenance of anaesthesia. It could also be used as a sedative for patients in the Intensive Care Unit (ICU).

PAION is currently exploring cooperation opportunities for the territories outside Japan, where the compound is partnered with Ono Pharmaceutical. Cooperations are vital for Paion in order to be able to progress the further development of Remimazolam as soon as possible.

Contact
Ralf Penner
Director Investor Relations / Public Relations
PAION AG
Martinstrasse 10-12
52062 Aachen - Germany
Phone: +49 241 4453-152
E-mail: r.penner@paion.com
www.paion.com


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.

   
Record changed: 2019-06-09

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