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PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS PARTNER YICHANG HUMANWELL IN CHINA
DGAP-News: PAION AG / Key word(s): Research Update
PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS
PARTNER YICHANG HUMANWELL IN CHINA
21.12.2016 / 14:00
The issuer is solely responsible for the content of this announcement.
PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS
PARTNER YICHANG HUMANWELL IN CHINA
21.12.2016 / 14:00
The issuer is solely responsible for the content of this announcement.
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PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS
PARTNER YICHANG HUMANWELL IN CHINA
- Second Phase I study with continuous infusion has completed recruitment
Aachen, 21 December 2016 - PAION AG, a specialty pharma company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces
that its Chinese remimazolam licensing partner Yichang Humanwell informed
PAION that their second Phase I study started in September 2016 has
successfully completed recruitment.
This Phase I study has tested various infusion rates of remimazolam in
healthy Chinese volunteers in order to prepare further studies in general
anesthesia.
A Phase II study in procedural sedation in China will start shortly.
###
About Remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/
anesthetic, currently in Phase III clinical development for procedural
sedation in the U.S. The first of two pivotal Phase III studies was
completed successfully and reached its primary endpoint. 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. 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 by Cosmo following completion of current 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. Based on the positive
results of the Phase II study in Japan, development for ICU sedation beyond
24 hours is
considered following successful completion of development in procedural
sedation and general anesthesia.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey,
the MENA region, and South Korea with Cosmo, Pharmascience (Pendopharm),
Yichang Humanwell, R-Pharm, TR-Pharm, and Hana Pharm, respectively. For all
other markets, remimazolam is available for licensing.
PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS
PARTNER YICHANG HUMANWELL IN CHINA
- Second Phase I study with continuous infusion has completed recruitment
Aachen, 21 December 2016 - PAION AG, a specialty pharma company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces
that its Chinese remimazolam licensing partner Yichang Humanwell informed
PAION that their second Phase I study started in September 2016 has
successfully completed recruitment.
This Phase I study has tested various infusion rates of remimazolam in
healthy Chinese volunteers in order to prepare further studies in general
anesthesia.
A Phase II study in procedural sedation in China will start shortly.
###
About Remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/
anesthetic, currently in Phase III clinical development for procedural
sedation in the U.S. The first of two pivotal Phase III studies was
completed successfully and reached its primary endpoint. 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. 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 by Cosmo following completion of current 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. Based on the positive
results of the Phase II study in Japan, development for ICU sedation beyond
24 hours is
considered following successful completion of development in procedural
sedation and general anesthesia.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey,
the MENA region, and South Korea with Cosmo, Pharmascience (Pendopharm),
Yichang Humanwell, R-Pharm, TR-Pharm, and Hana Pharm, respectively. For all
other markets, remimazolam is available for licensing.
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