DGAP-News: PAION AG ANNOUNCES POSITIVE END-OF-PHASE II MEETING WITH FDA FOR REMIMAZOLAM IN PROCEDURAL SEDATION
(firmenpresse) - DGAP-News: PAION AG / Key word(s): Research Update
PAION AG ANNOUNCES POSITIVE END-OF-PHASE II MEETING WITH FDA FOR
REMIMAZOLAM IN PROCEDURAL SEDATION
25.11.2013 / 07:30
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PAION AG ANNOUNCES POSITIVE END-OF-PHASE II MEETING WITH FDA FOR
REMIMAZOLAM IN PROCEDURAL SEDATION
- FDA offers support to achieve planned label
- Costs for completion of the clinical procedural sedation development
program estimated at appr. EUR 20 million
- US Phase III to start in H2/2014 depending on successful completion of
current funding and/or partnering discussions
Aachen (Germany), 25 November 2013 - PAION AG (ISIN DE000A0B65S3; Frankfurt
Stock Exchange General Standard: PA8) today announced that it held an
End-of-Phase II meeting with the U.S. Food and Drug Administration (FDA) to
discuss PAION's Remimazolam for the US lead indication 'procedural
sedation' and now received the final meeting minutes. At that meeting, the
FDA laid out its expectations for the remaining development program up to
NDA filing and offered a dialogue to finalise the necessary study designs
together with PAION. A pivotal Phase III program evaluating the safety and
efficacy of Remimazolam is planned to start in H2/2014 depending on
successful completion of current funding and/or partnering discussions. The
cost for completion of the procedural sedation development program is
currently estimated at approximately EUR 20 million and is depending on the
final requirements of the FDA.
Labelling comparable to Midazolam may be achieved if the Phase III studies
are designed and the safety data continue to support such claim. FDA has
agreed to work with PAION on the design of the Phase III studies to support
the desired labelling. PAION aims at a label similar to that for
Midazolam.
Midazolam is a very safe agent for induction of conscious sedation, but
long recovery times for the patient reduce the numbers of procedures that
can be performed by GI docs who therefore often use propofol to double the
number of patients that can be screened. The high numbers of patients are
necessary to achieve the goal to screen as many patients as possible, as it
is the only proven preventive colon cancer intervention. Remimazolam is
expected to be as safe as Midazolam and PAION hopes to demonstrate in Phase
III studies designed with FDA input that significantly more patients can be
screened without the additional costs for the healthcare system of having
an anaesthesiologist present to administer the sedative (like with
propofol). Both, Remimazolam and Midazolam, share the advantage of having a
reversal agent which enhances the safety profile of the compounds.
With this safety profile, supported by collection of positive safety
results from the Phase III studies Remimazolam could offer savings to the
healthcare system if approved for administration by persons trained in
airway management. As this could result in a savings potential of>$1
billion per year for simple procedures such as colonoscopies, PAION sees a
very attractive business case for conscious sedation in the US market.
Dr. Mariola Söhngen, the Chief Medical Officer at PAION states: 'Our
constructive discussions with the FDA have defined the relatively short
remaining development path for Remimazolam in the US. This feedback
increases our chances to secure financing in order to provide an
alternative to the anaesthesia/sedation market in the nearer future. We
expect that the savings potential in the healthcare budget will be
positively received in times of increasing budget pressures on healthcare
providers.'
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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
- General anaesthesia
- ICU sedation
Remimazolam is available for licensing outside Japan, China, Russia (CIS),
and South Korea, where the compound is partnered with Ono Pharmaceutical,
Yichang Humanwell, R-Pharm and Hana Pharm.
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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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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240831 25.11.2013
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