DGAP-News: PAION ANNOUNCES CLINICAL DEVELOPMENT OF SHORT-ACTING ANAESTHETIC/SEDATIVE REMIMAZOLAM IN GENERAL ANAESTHESIA
(firmenpresse) - DGAP-News: PAION AG / Key word(s): Research Update
PAION ANNOUNCES CLINICAL DEVELOPMENT OF SHORT-ACTING
ANAESTHETIC/SEDATIVE REMIMAZOLAM IN GENERAL ANAESTHESIA
06.03.2013 / 08:07
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PAION ANNOUNCES CLINICAL DEVELOPMENT OF SHORT-ACTING ANAESTHETIC/SEDATIVE
REMIMAZOLAM IN GENERAL ANAESTHESIA
- 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
Aachen (Germany), 06 March 2013 - 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 ofthese payments, PAION now has sufficient funds until the end of
Q1 2015, which includes the funds needed to perform the European Phase II
trial.
###
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(at)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.
End of Corporate News
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06.03.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EquityStory 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(at)paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (General Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
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202974 06.03.2013
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Datum: 06.03.2013 - 08:07 Uhr
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