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19.06.2016 17:49:21
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DGAP-News: PAION AG
DGAP-News: PAION REPORTS POSITIVE REMIMAZOLAM HEADLINE DATA IN PIVOTAL U.S. PHASE III STUDY IN PROCEDURAL SEDATION FOR COLONOSCOPY
- Primary efficacy outcome measure successfully achieved
- Consistent safety profile with that observed in previous studies
- Conference Call on remimazolam headline data on Monday, 20 June 2016
Aachen (Germany), 19 June 2016 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announced that remimazolam, its ultra-short-acting benzodiazepine sedative/ anesthetic, met its primary efficacy endpoint in the first study of its pivotal U.S. Phase III program in patients undergoing procedural sedation.
The study enrolled a total of 461 patients at 13 U.S. sites and was designed to evaluate the efficacy and safety of remimazolam compared to placebo (with midazolam rescue) in patients undergoing proceduralist- administered sedation for colonoscopy. The primary outcome measure, success of the procedure, was reached in 91.3% of the patients in the remimazolam arm and in 5.0% in the placebo (including midazolam rescue) arm. The safety profile of remimazolam was consistent with that observed in previous studies.
In important secondary endpoints, the remimazolam arm showed a mean time to start of procedure of 5.1 minutes and a mean time from end of procedure to return to full alertness of the patients of 9.25 minutes. Evaluation of the full data set is ongoing and will be presented in an appropriate scientific, peer-reviewed format at a later date.
This study also included an open label arm in which midazolam was dosed according to U.S. label. The data resulting from this non-comparative arm may be useful for hypothesis generation for future research and pharmaco- economic modelling.
Although the study designs are not identical, the Phase III study results were in line with findings from a previous U.S. Phase IIb double-blind randomized comparative study between remimazolam and midazolam in 162 patients undergoing routine colonoscopy, where patients in the remimazolam arm showed significantly enhanced colonoscopy success rates and shorter times to start of procedure, shorter times from end of procedure to return to full alertness and, therefore, shorter overall procedure times than patients in the midazolam arm.
"The study results show that remimazolam has the potential to be an important addition to existing options for sedating patients undergoing procedures such as colonoscopy", commented Professor Douglas Rex M.D., co- ordinating investigator, Indiana University, Indianapolis, U.S.A. "The short onset and offset of action times are particularly interesting from an out-patient clinic perspective as these may lead to more efficient patient management. We will learn more from the publication of the full remimazolam data analysis of the ongoing Phase III program."
Dr. Johannes Blatter, Chief Medical Officer at PAION AG, commented: "We are excited about the headline data from remimazolam's first U.S. Phase III study and the potential it has to be an effective, safe and efficient agent for procedural sedation; an area of medicine that has seen significant growth in the number of procedures for preventative and diagnostic interventions such as colorectal cancer screening. These headline data are in line with data from the earlier Phase IIb study in terms of efficacy and safety profile and point towards shorter times to start of procedure and shorter times to return to full alertness in relation to midazolam. Remimazolam has the potential to improve patient satisfaction and enhance patient care in the out-patient clinic setting."
Dr. Wolfgang Söhngen, CEO at PAION AG, commented: "First of all, I would like to thank all those who contributed to the success of this milestone study for PAION. These data are also interesting in the context of increasing concerns about the overall cost of procedures and potential changes to reimbursement structures in the U.S. We believe that remimazolam has the potential to play a significant role in improving the efficiency of patient care in procedural sedation."
Conference call: PAION will hold a conference call in German on Monday, 20 June 2016, at 10.00 a.m. CEST (9 a.m. BST) for media representatives and shareholders.
PAION will also be available for analysts and investors in a conference call in English at 4.00 p.m. CEST (3 p.m. BST, 10 a.m. EDT) on the same day.
To access the calls participants may dial from - Germany +49 (0) 69 7104 45598
- UK +44 (0) 20 3003 2666 and
- US +1 212 999 6659
- (other countries: please use the UK number).
When prompted, you will be asked to give the password "PAION". The conference call will be supplemented by a webcast presentation which can be accessed during the call with the following link for the German call at 10.00 a.m. CEST: https://paion-events.webex.com/paion-events/j.php? MTID=m4e36a6adf74b8e36a7be33a16860d337
and
using the following link for the English call at 4.00 p.m. CEST: https:// paion-events.webex.com/paion-events/j.php? MTID=mbcb36cea99ba5c300bd133cf8e94d33a
###
About remimazolam Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/ anesthetic, currently in Phase III clinical development for procedural sedation. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome- dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary.
In clinical studies, remimazolam demonstrated efficacy and safety in over 1,000 patients. A Phase III program is currently in progress in procedural sedation in the U.S. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
A pediatric development plan has been agreed with the FDA and will be implemented following the development of remimazolam for adult patients. A full clinical development program for general anesthesia has been completed in Japan, and a Phase II study in general anesthesia has been completed in the E.U. Development for ICU sedation beyond 24 hours is considered following successful completion of development in procedural sedation and general anesthesia.
Remimazolam is available for licensing outside China, Russia (CIS), Turkey, the MENA region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pharmascience (Pendopharm), respectively.
About PAION PAION AG is a publicly listed specialty pharmaceutical company headquartered in Aachen (Germany) with in Cambridge (United Kingdom) and New Jersey (USA). PAION's lead substance, remimazolam, is an intravenous ultra-short-acting benzodiazepine sedative/anesthetic currently in Phase III clinical development for procedural sedation. Remimazolam is designed to complement and improve currently available treatment options for patients requiring sedation and anesthesia. PAION is focusing its clinical development activities on remimazolam according to PAION's vision to become an acknowledged "PAIONeer" in sedation and anesthesia.
For more information please visit www.paion.com
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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19.06.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.dgap.de
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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: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of News DGAP News Service ---------------------------------------------------------------------------
472663 19.06.2016
DGAP-News: PAION AG / Key word(s): Research Update
PAION REPORTS POSITIVE REMIMAZOLAM HEADLINE DATA IN PIVOTAL U.S. PHASE III
STUDY IN PROCEDURAL SEDATION FOR COLONOSCOPY
19.06.2016 / 17:49
The issuer is solely responsible for the content of this announcement.
---------------------------------------------------------------------------
PAION REPORTS POSITIVE REMIMAZOLAM HEADLINE DATA IN PIVOTAL U.S. PHASE III
STUDY IN PROCEDURAL SEDATION FOR COLONOSCOPY
- Primary efficacy outcome measure successfully achieved
- Consistent safety profile with that observed in previous studies
- Conference Call on remimazolam headline data on Monday, 20 June 2016
Aachen (Germany), 19 June 2016 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announced that remimazolam, its ultra-short-acting benzodiazepine sedative/ anesthetic, met its primary efficacy endpoint in the first study of its pivotal U.S. Phase III program in patients undergoing procedural sedation.
The study enrolled a total of 461 patients at 13 U.S. sites and was designed to evaluate the efficacy and safety of remimazolam compared to placebo (with midazolam rescue) in patients undergoing proceduralist- administered sedation for colonoscopy. The primary outcome measure, success of the procedure, was reached in 91.3% of the patients in the remimazolam arm and in 5.0% in the placebo (including midazolam rescue) arm. The safety profile of remimazolam was consistent with that observed in previous studies.
In important secondary endpoints, the remimazolam arm showed a mean time to start of procedure of 5.1 minutes and a mean time from end of procedure to return to full alertness of the patients of 9.25 minutes. Evaluation of the full data set is ongoing and will be presented in an appropriate scientific, peer-reviewed format at a later date.
This study also included an open label arm in which midazolam was dosed according to U.S. label. The data resulting from this non-comparative arm may be useful for hypothesis generation for future research and pharmaco- economic modelling.
Although the study designs are not identical, the Phase III study results were in line with findings from a previous U.S. Phase IIb double-blind randomized comparative study between remimazolam and midazolam in 162 patients undergoing routine colonoscopy, where patients in the remimazolam arm showed significantly enhanced colonoscopy success rates and shorter times to start of procedure, shorter times from end of procedure to return to full alertness and, therefore, shorter overall procedure times than patients in the midazolam arm.
"The study results show that remimazolam has the potential to be an important addition to existing options for sedating patients undergoing procedures such as colonoscopy", commented Professor Douglas Rex M.D., co- ordinating investigator, Indiana University, Indianapolis, U.S.A. "The short onset and offset of action times are particularly interesting from an out-patient clinic perspective as these may lead to more efficient patient management. We will learn more from the publication of the full remimazolam data analysis of the ongoing Phase III program."
Dr. Johannes Blatter, Chief Medical Officer at PAION AG, commented: "We are excited about the headline data from remimazolam's first U.S. Phase III study and the potential it has to be an effective, safe and efficient agent for procedural sedation; an area of medicine that has seen significant growth in the number of procedures for preventative and diagnostic interventions such as colorectal cancer screening. These headline data are in line with data from the earlier Phase IIb study in terms of efficacy and safety profile and point towards shorter times to start of procedure and shorter times to return to full alertness in relation to midazolam. Remimazolam has the potential to improve patient satisfaction and enhance patient care in the out-patient clinic setting."
Dr. Wolfgang Söhngen, CEO at PAION AG, commented: "First of all, I would like to thank all those who contributed to the success of this milestone study for PAION. These data are also interesting in the context of increasing concerns about the overall cost of procedures and potential changes to reimbursement structures in the U.S. We believe that remimazolam has the potential to play a significant role in improving the efficiency of patient care in procedural sedation."
Conference call: PAION will hold a conference call in German on Monday, 20 June 2016, at 10.00 a.m. CEST (9 a.m. BST) for media representatives and shareholders.
PAION will also be available for analysts and investors in a conference call in English at 4.00 p.m. CEST (3 p.m. BST, 10 a.m. EDT) on the same day.
To access the calls participants may dial from - Germany +49 (0) 69 7104 45598
- UK +44 (0) 20 3003 2666 and
- US +1 212 999 6659
- (other countries: please use the UK number).
When prompted, you will be asked to give the password "PAION". The conference call will be supplemented by a webcast presentation which can be accessed during the call with the following link for the German call at 10.00 a.m. CEST: https://paion-events.webex.com/paion-events/j.php? MTID=m4e36a6adf74b8e36a7be33a16860d337
and
using the following link for the English call at 4.00 p.m. CEST: https:// paion-events.webex.com/paion-events/j.php? MTID=mbcb36cea99ba5c300bd133cf8e94d33a
###
About remimazolam Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/ anesthetic, currently in Phase III clinical development for procedural sedation. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and not metabolized by cytochrome- dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation and anesthesia if necessary.
In clinical studies, remimazolam demonstrated efficacy and safety in over 1,000 patients. A Phase III program is currently in progress in procedural sedation in the U.S. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
A pediatric development plan has been agreed with the FDA and will be implemented following the development of remimazolam for adult patients. A full clinical development program for general anesthesia has been completed in Japan, and a Phase II study in general anesthesia has been completed in the E.U. Development for ICU sedation beyond 24 hours is considered following successful completion of development in procedural sedation and general anesthesia.
Remimazolam is available for licensing outside China, Russia (CIS), Turkey, the MENA region, South Korea and Canada, where the compound is partnered with Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pharmascience (Pendopharm), respectively.
About PAION PAION AG is a publicly listed specialty pharmaceutical company headquartered in Aachen (Germany) with in Cambridge (United Kingdom) and New Jersey (USA). PAION's lead substance, remimazolam, is an intravenous ultra-short-acting benzodiazepine sedative/anesthetic currently in Phase III clinical development for procedural sedation. Remimazolam is designed to complement and improve currently available treatment options for patients requiring sedation and anesthesia. PAION is focusing its clinical development activities on remimazolam according to PAION's vision to become an acknowledged "PAIONeer" in sedation and anesthesia.
For more information please visit www.paion.com
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.
---------------------------------------------------------------------------
19.06.2016 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG. The issuer is solely responsible for the content of this announcement.
The DGAP Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Archive at www.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: info@paion.com Internet: www.paion.com ISIN: DE000A0B65S3 WKN: A0B65S Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart End of News DGAP News Service ---------------------------------------------------------------------------
472663 19.06.2016
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