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PAION AG REPORTS HEADLINE DATA OF ONO'S PHASE II/III TRIAL - REMIMAZOLAM MEETS PRIMARY ENDPOINT AND SHOWS GOOD SAFETY DATA
Nachrichtenquelle: EQS Group AG
| 14.11.2013, 09:16 | 229 Aufrufe | 0 |
DGAP-News: PAION AG / Key word(s): Study
PAION AG REPORTS HEADLINE DATA OF ONO'S PHASE II/III TRIAL -
REMIMAZOLAM MEETS PRIMARY ENDPOINT AND SHOWS GOOD SAFETY DATA
14.11.2013 / 09:16
---------------------------------------------------------------------
PAION AG REPORTS HEADLINE DATA OF ONO'S PHASE II/III TRIAL - REMIMAZOLAM
MEETS PRIMARY ENDPOINT AND SHOWS GOOD SAFETY DATA
- Completion of phase II/III study in 375 patients
- Primary Endpoint successfully met
- Excellent cardiovascular stability confirmed
- Excellent safety profile of Remimazolam confirmed
Aachen (Germany), 14 November 2013 - 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/III clinical study of
Remimazolam (development codes: ONO-2745/CNS 7056) in its lead indication
of General Anaesthesia successfully met the primary endpoint.
The study was conducted in Japan as a multi-centre randomized
parallel-group study with propofol as a control in surgery patients
undergoing general anaesthesia in combination with analgesics. Remimazolam
and propofol were intravenously administered to 375 patients (2 Remimazolam
groups with induction doses of 6 mg/kg/h or 12 mg/kg/h and started at the
rate of 1 mg/kg/h for maintenance, 150 subjects per group) and 75 patients
received a standard dose of propofol, respectively, to compare success
rates of induction and maintenance of general anaesthesia.
All 375 patients achieved loss of consciousness and underwent successful
intubation. The primary efficacy endpoint of effectiveness as a general
anaesthetic (defined as no intraoperative awakening/memory, no body motion
and no rescue therapy for sedative effect necessary) was achieved by 100%
of patients in all groups. Typically for an anaesthesia study the study was
designed as non-inferiority study vs. standard of care, in this case i.v.
propofol.
No adverse events of concern were observed. The incidence rates of adverse
events were 84.7%, 80.7% and 84.0% in 6 mg/kg/h and 12 mg/kg/h of
Remimazolam and propofol groups, respectively. Common adverse events
included decrease of blood pressure, primary wound complication, abnormal
laboratory test results, nausea/vomiting and injection site pain (observed
only in the propofol group) etc, which corresponded with relatively common
events typically observed in perioperative patients. The incidence rates of
decrease in blood pressure were 35.3%, 34.7% and 60.0% in 6 mg/kg/h and 12
mg/kg/h of Remimazolam and propofol groups, respectively. This suggests
that Remimazolam has a clinically meaningfully less cardio depressive
effect as compared to propofol. The incidence rate was significantly lower
in each Remimazolam group as compared to the propofol group (p=0.0004 and
p=0.0003 for the 6 and 12 mg/kg/h doses vs. propofol).
Pharmacokinetic and pharmacodynamic modelling is still ongoing.
ONO entered into a license agreement with PAION (formerly CeNeS) in August
2007, acquiring the exclusive right to develop and market Remimazolam in
Japan.
Dr. Mariola Söhngen, the Chief Medical Officer at PAION states: 'We
congratulate our partner ONO on the completion of the Phase II/III study in
anaesthesia and meeting the primary endpoint. Importantly this data will be
a major contribution for our own development in General Anaesthesia and the
overall safety data base for Remimazolam. The fact that Remimazolam caused
significantly less drops in blood pressure is particularly important and
very encouraging, specifically with respect to our ongoing Phase II study
in cardiac surgery patients, where this is one of the key expected
outcomes.'
###
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 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. Due
to its short duration of action and good controllability, it has a
favorable 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: [email protected]
Aktuelle Unternehmensmeldungen
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
---------------------------------------------------------------------
14.11.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at DGAP-MedienTreff für ? and Aktuelle Finanznachrichten und Börseninfos direkt von der Quelle - dgap.de
---------------------------------------------------------------------
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: [email protected]
Internet: Aktuelle Unternehmensmeldungen
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (General Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
Nachrichtenquelle: EQS Group AG
| 14.11.2013, 09:16 | 229 Aufrufe | 0 |
DGAP-News: PAION AG / Key word(s): Study
PAION AG REPORTS HEADLINE DATA OF ONO'S PHASE II/III TRIAL -
REMIMAZOLAM MEETS PRIMARY ENDPOINT AND SHOWS GOOD SAFETY DATA
14.11.2013 / 09:16
---------------------------------------------------------------------
PAION AG REPORTS HEADLINE DATA OF ONO'S PHASE II/III TRIAL - REMIMAZOLAM
MEETS PRIMARY ENDPOINT AND SHOWS GOOD SAFETY DATA
- Completion of phase II/III study in 375 patients
- Primary Endpoint successfully met
- Excellent cardiovascular stability confirmed
- Excellent safety profile of Remimazolam confirmed
Aachen (Germany), 14 November 2013 - 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/III clinical study of
Remimazolam (development codes: ONO-2745/CNS 7056) in its lead indication
of General Anaesthesia successfully met the primary endpoint.
The study was conducted in Japan as a multi-centre randomized
parallel-group study with propofol as a control in surgery patients
undergoing general anaesthesia in combination with analgesics. Remimazolam
and propofol were intravenously administered to 375 patients (2 Remimazolam
groups with induction doses of 6 mg/kg/h or 12 mg/kg/h and started at the
rate of 1 mg/kg/h for maintenance, 150 subjects per group) and 75 patients
received a standard dose of propofol, respectively, to compare success
rates of induction and maintenance of general anaesthesia.
All 375 patients achieved loss of consciousness and underwent successful
intubation. The primary efficacy endpoint of effectiveness as a general
anaesthetic (defined as no intraoperative awakening/memory, no body motion
and no rescue therapy for sedative effect necessary) was achieved by 100%
of patients in all groups. Typically for an anaesthesia study the study was
designed as non-inferiority study vs. standard of care, in this case i.v.
propofol.
No adverse events of concern were observed. The incidence rates of adverse
events were 84.7%, 80.7% and 84.0% in 6 mg/kg/h and 12 mg/kg/h of
Remimazolam and propofol groups, respectively. Common adverse events
included decrease of blood pressure, primary wound complication, abnormal
laboratory test results, nausea/vomiting and injection site pain (observed
only in the propofol group) etc, which corresponded with relatively common
events typically observed in perioperative patients. The incidence rates of
decrease in blood pressure were 35.3%, 34.7% and 60.0% in 6 mg/kg/h and 12
mg/kg/h of Remimazolam and propofol groups, respectively. This suggests
that Remimazolam has a clinically meaningfully less cardio depressive
effect as compared to propofol. The incidence rate was significantly lower
in each Remimazolam group as compared to the propofol group (p=0.0004 and
p=0.0003 for the 6 and 12 mg/kg/h doses vs. propofol).
Pharmacokinetic and pharmacodynamic modelling is still ongoing.
ONO entered into a license agreement with PAION (formerly CeNeS) in August
2007, acquiring the exclusive right to develop and market Remimazolam in
Japan.
Dr. Mariola Söhngen, the Chief Medical Officer at PAION states: 'We
congratulate our partner ONO on the completion of the Phase II/III study in
anaesthesia and meeting the primary endpoint. Importantly this data will be
a major contribution for our own development in General Anaesthesia and the
overall safety data base for Remimazolam. The fact that Remimazolam caused
significantly less drops in blood pressure is particularly important and
very encouraging, specifically with respect to our ongoing Phase II study
in cardiac surgery patients, where this is one of the key expected
outcomes.'
###
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 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. Due
to its short duration of action and good controllability, it has a
favorable 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: [email protected]
Aktuelle Unternehmensmeldungen
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
---------------------------------------------------------------------
14.11.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at DGAP-MedienTreff für ? and Aktuelle Finanznachrichten und Börseninfos direkt von der Quelle - dgap.de
---------------------------------------------------------------------
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: [email protected]
Internet: Aktuelle Unternehmensmeldungen
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (General Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service