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Paion AG. (3/6/13). "Press Release: Paion Announces Clinical Development of Short-acting Anaesthetic/Sedative Remimazolam in General Anaesthesia". Aachen.

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 desmoteplase
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)
     


- Focus on Phase II trial in General Anaesthesia to begin in the 2nd half of 2013

- Financing secured until end of Q1 2015 including the Remimazolam Phase II European trial

- PAION decide to put on hold the launch of Remifentanil in Germany due to significant unexpected price erosion

- Final payment received from Lundbeck in the amount of EUR 1.5 million from the February 2012 Desmoteplase sale

- EUR 1.2 million due to completion of Remimazolam technology transfer with Yichang


PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, General Standard: PA8), a biopharmaceutical company, announced today that it is in advanced preparation to conduct a Phase II trial with the short-acting anesthetic/sedative, Remimazolam, in General Anaesthesia in cardiovascular surgery in the 2nd half of 2013. In May 2012, Remimazolam successfully completed a Phase II trial in General Anaesthesia in Japan. A Phase II/III trial of Remimazolam in General Anesthesia was started by PAION's collaboration partner, ONO, in November 2012.

In February 2013, PAION held a formal scientific advice meeting with the German regulatory authority on the European clinical development program for Remimazolam in General Anaesthesia. Pending the outcome of the planned and ongoing trials, PAION assumes that a single Phase II and a single Phase III trial in General Anaesthesia in addition to the Japanese Phase II/III trial will be sufficient for EU approval. In preparation for the European Phase III trial, further scientific advice meetings are planned with European regulatory authorities. PAION expects to conduct this trial in 2014.

Dr. Wolfgang Söhngen, CEO of PAION, commented: 'Due to the impressive progress of ONO's clinical development program for Remimazolam, we are now able to initiate a late-stage European program in General Anaesthesia with a very targeted and focused approach. The data package that we have generated in Procedural Sedation will be an integral part of the safety database. '

Due to the unexpected significant price erosion in the German Remifentanil market over the last six months, PAION has put on hold the launch of generic Remifentanil into the German market. Together with its Manufacturer PAION will further evaluate the prevailing market conditions before taking a final decision on Remifentanil. PAION remains committed to its vision 'PAIONeer in Anaesthesia' and maintains its plan to launch suitable companion products to prepare for the market entry of Remimazolam in Europe.

Today PAION announced that it has received the final payment of EUR 1.5 million from Lundbeck related to the February 2012 sale of Desmoteplase rights.

Based on the license agreement signed with Yichang in July 2012 further EUR 1.2 million are now due to the successful completion of the Remimazolam technology transfer. Yichang Humanwell has an exclusive Remimazolam licence for the development, manufacture and commercialization in China. As a result of these payments, PAION now has sufficient funds until the end of Q1 2015, which includes the funds needed to perform the European Phase II trial.

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About PAION

PAION AG is a publicly-listed biotech company headquartered in Aachen, Germany with a second site in Cambridge, UK. The company has a track record in developing hospital-based treatments for which there is substantial unmet medical need. PAION AG is transforming its business model from a pure development company to a specialty pharmaceutical company with a focus on anaesthesia products to take advantage of the unique profile of its main compound, Remimazolam.


About Remimazolam

Remimazolam is an innovative short-acting general anaesthetic/sedative. Due to its short duration of action and good controllability, it has a preferable efficacy and safety profile relative to other currently marketed anaesthesia compounds. The rapid offset of Remimazolam's effect 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: PAION)

- General anaesthesia (Phase II/III ongoing: ONO; Phase II in preparation: PAION)

- ICU sedation (Phase II ongoing: ONO)

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


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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