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    DGAP-News  751  0 Kommentare 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.

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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.
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    DGAP-News 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. …