DGAP-News: PAION AG / Key word(s): Research Update
PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS
PARTNER YICHANG HUMANWELL IN CHINA
06.09.2016 / 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
- First Phase I study started in October 2015 has completed recruitment
- Yichang Humanwell has started a new Phase I study with continuous
infusion
- A Phase II study in procedural sedation is in preparation
Aachen, 06 September 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 has
informed PAION that their first Phase I study started in October 2015 has
completed recruitment. In addition Yichang Humanwell has started a second
Phase I study with continuous infusion in order to prepare a study in
general anesthesia.
A Phase II study in procedural sedation in China is in preparation.
Yichang Humanwell initially planned to develop remimazolam for general
anesthesia for the Chinese market but has now decided to develop
remimazolam in procedural sedation as well. The rights to develop and
market remimazolam for the Chinese market were granted to Yichang Humanwell
in 2012.
The completed Phase I study tested a range of single bolus doses of
remimazolam in healthy volunteers. The next Phase I study will test various
infusion rates of remimazolam, again in healthy Chinese volunteers.
The Phase II study will be performed with patients undergoing various short
procedures where sedation is required and a range of bolus doses of
remimazolam will be tested to identify a safe and effective dose for future
studies.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented, "We congratulate Yichang
Humanwell on the progress as they had to go through a repetition of a
significant amount of pre-clinical work prior to starting clinical
development in China including setting up their own GMP manufacturing. We
look forward to learn more about the future progress in China."
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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. 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.
About PAION
PAION AG is a publicly listed specialty pharmaceutical company developing
and aiming to commercialize innovative drugs to be used in out-patient and
hospital-based sedation, anesthesia and critical care services. PAION's
lead compound is remimazolam, an intravenous, ultra-short-acting and
controllable benzodiazepine sedative/anesthetic drug candidate. Currently,
remimazolam is in active Phase III clinical development for use in
procedural sedation in the U.S., where PAION is focusing all its business
and financial resources on successfully completing its ongoing clinical
development program in procedural sedation. Outside the U.S., PAION has so
far focused on the development of remimazolam in the indication general
anesthesia. Development of remimazolam in the indication intensive care
unit (ICU) sedation is also part of the longer term life-cycle plan for
remimazolam.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey,
the MENA region, and South Korea.
PAION is headquartered in Aachen (Germany) with further sites in Cambridge
(United Kingdom) and New Jersey (USA).
PAION's vision is to become an acknowledged "PAIONeer" in sedation and
anesthesia.
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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06.09.2016 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,
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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, Tradegate Exchange
End of News DGAP News Service
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499243 06.09.2016
DGAP-News: PAION ANNOUNCES CLINICAL DEVELOPMENT PROGRESS WITH REMIMAZOLAM BY ITS PARTNER YICHANG HUMANWELL IN CHINA
| Source: EQS Group AG