DGAP-News: PAION AG / Key word(s): Conference
TWO SCIENTIFIC REMIMAZOLAM PRESENTATIONS ARE ACCEPTED FOR ASA AND ACG
MEETING IN OCTOBER 2014
01.10.2014 / 14:00
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TWO SCIENTIFIC REMIMAZOLAM PRESENTATIONS ARE ACCEPTED FOR ASA AND ACG
MEETING IN OCTOBER 2014
- Presentation of the Phase II trial results in anaesthesia at "The
Anesthesiology 2014 Annual Meeting" (ASA) on 13th October 2014 in New
Orleans, USA
- Presentation of the Phase IIb trial results in procedural sedation at
"American College of Gastroenterology Annual Scientific Meeting" (ACG),
21th October 2014 in Philadelphia, USA
Aachen, 01 October 2014 - PAION AG, a Specialty Pharma Company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) announces today
that scientific abstracts about clinical data of Remimazolam were accepted
for presentation at two major US congresses. The lead investigators will
present the clinical results and PAION the hypothetical product profile of
its innovative, short acting anaesthetic/sedative to professionals;
consisting of gastroenterologists, anaesthetists, surgeons and intensive
care professionals. The booth in the commercial exhibition is part of the
planned pre-marketing activities.
The presentation by lead investigator Dr Stefan Probst at ASA will be
during the session "Drug Disposition, Metabolism and Elimination" at ASA on
13th October 2014 from 3 pm to 4:30 pm. The title of the abstract is:
"Phase II Study of an Ultra-Short Acting Benzodiazepine (Remimazolam)
Versus a Standard Regime of Propofol/Sevoflurane in Patients Undergoing
Cardio-Surgery". The presentation will be available for download on the
company's website www.paion.com. The Phase II study in anaesthesia was
conducted at the Heart Center Leipzig/Germany from September 2013 to
February 2014.
The Phase II study was a randomized, Propofol and Sevoflurane (standard
treatment) controlled Phase II study to evaluate the efficacy, tolerability
and pharmacokinetics of Remimazolam during general anaesthesia in patients
undergoing cardiac surgery using a heart-lung machine. After surgery a
follow up sedation in the recovery room or in the intensive care unit (ICU)
for up to 24 h was part of the protocol. A total of 90 patients have been
treated.
The primary efficacy endpoint as a general anaesthetic (defined as
successful anaesthesia not requiring sedative rescue therapy) was achieved
in 98% of patients in the two Remimazolam dose groups and 96% in the
Propofol/Sevoflurane group. Therefore, an excellent efficacy rate across
all treatment groups was shown. The safety profile was generally very good
in all treatment groups.
One of the key targets of this trial was to assess the cardiostability
during cardiac surgery with Remimazolam when compared to
Propofol/Sevoflurane, both of which are known to cause cardiac depression.
During cardiac surgery norepinephrine is routinely used to maintain blood
pressure in the normal range and counteract pronounced blood pressure
decreases.
In this study the total norepinephrine dose used was 36.7 % lower in
Remimazolam treated patients when compared to the Propofol/Sevoflurane
group which can be regarded as a clinically significant differentiation.
The ASA meeting is the largest international anaesthesia congress.
Remimazolam's lead indication in Europe is to be presented also to U.S.
Anaesthesiologists because after successful approval in Europe the NDA (New
Drug Application)for the indication "General anesthesia" will be also
applied for in the U.S.
PAION will be available for discussions at booth 343 in the exhibition
hall.
During the ACG meeting Dr Daniel J. Pambianco, the lead investigator of the
Phase IIb trial, will present the results of the colonoscopy study during
the session "Endoscopy/Colorectal Cancer Prevention on 21 October 2014
between 8.30 am to 10 am. The title of the abstract is: "A Phase IIb Study
Comparing the Safety and Efficacy of Remimazolam and Midazolam in
Colonoscopy Patients". The presentation will be available for download on
the company's website www.paion.com. In connection with ASA a kick off
meeting with potential investigators for the Phase III program will also be
held.
PAION will be available for discussions at booth 751 in the exhibition
hall.
The Phase IIb trial was a double-blind, randomized, parallel group study
examining three dose regimens of Remimazolam compared with Midazolam in 160
patients undergoing a colonoscopy. The patients received either one of
three different initial doses of Remimazolam or Midazolam followed by
"top-ups" (i.e. multiple doses) as required to maintain an adequate
sedation level to undergo a standard colonoscopy procedure. The study -
conducted in multiple sites in the U.S. - was designed to evaluate the
success of the sedation under Remimazolam and the time to peak sedation as
well as the time to full recovery and discharge, and safety, in comparison
to the gold-standard agent, Midazolam. In addition, based on the results of
the successfully conducted Phase Ib and IIa studies, this study was
designed to further refine the optimal dose regimen before moving into
Phase III.
The primary objective of the trial, to assess the success of a colonoscopy
procedure in comparison to Midazolam, was met, and showed success rates
ranging from 92.5% to 97.5% with the 3 Remimazolam dose groups, compared to
75 % with Midazolam. Thus Remimazolam was clinically superior compared to
the current gold standard Midazolam. The primary endpoint was a composite
consisting of the following: "sedation sufficient to initiate and complete
the procedure, no mechanical or manual ventilation and no rescue sedation".
25% of the patients in the Midazolam group received Propofol as sedative
rescue medication compared to 5 % in the combined Remimazolam groups who
received either Propofol or Midazolam. This study from 2010 was the third
showing a clinically relevant improvement in the course of sedation in
comparison to Midazolam.
"We are proud that distinguished scientific organizations like ASA and ACG
accepted scientific Remimazolam presentations. This shows that the current
product profile attracts increasing attention and underscores the medical
need both in conscious sedation and general anesthesia. The presentation of
Remimazolam during scientific conferences and congresses is part of the
international scientific dialogue about Remimazolam. Furthermore this will
initiate our pre-marketing activities that we conduct to accompany the
Phase III program both in the US and Europe", comments Dr. Wolfgang
Söhngen, CEO at PAION.
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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)
Turkey, South Korea and Canada, where the compound is partnered with, Ono
Pharmaceutical, Yichang Humanwell, R-Pharm, Hana Pharm and Pendopharm.
About PAION
PAION AG is a publicly-listed Specialty Pharma 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's strategy is to extend its business
model from a pure development company to a specialty pharmaceutical company
with a focus on anaesthesia products. Remimazolam is intended to be the
basis for its future marketing activities.
PAION 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.
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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@paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
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289528 01.10.2014
DGAP-News: TWO SCIENTIFIC REMIMAZOLAM PRESENTATIONS ARE ACCEPTED FOR ASA AND ACG MEETING IN OCTOBER 2014
| Source: EQS Group AG