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    DGAP-News  592  0 Kommentare PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY - Seite 2


    into the overall efficacy and safety data sets for the FDA filing process."

    Dr. Johannes Blatter, PAION's CMO, commented: "We are extremely satisfied
    with the course of the study. The inclusion and treatment of 460 patients
    was carried out very efficiently. I would like to give a special thanks to
    the internal and external teams, which have ensured a high quality study
    with their tireless efforts, enthusiasm and care."

    ###

    About Remimazolam
    Remimazolam is an ultra-short-acting intravenous sedative and anesthetic,
    currently in Phase III clinical development for procedural sedation and
    general anesthesia. Remimazolam is a member of the class of substances
    known as benzodiazepines. 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 in order to
    rapidly terminate sedation if necessary.

    In clinical studies, Remimazolam demonstrated efficacy and safety in far
    more than 1,000 patients. A confirmatory Phase III program is currently in
    progress in procedural sedation. Data so far indicate that Remimazolam has
    the expected rapid onset and offset of action combined with a favorable
    hemodynamic stability profile.

    In the U.S., Remimazolam is currently being developed for procedural
    sedation during procedures such as colonoscopies.

    In the EU and most other major markets, Remimazolam is initially being
    developed for general anesthesia, including post-operative sedation in
    post-anesthesia care or intensive care units (ICUs) for up to 24 hours
    after the operation.

    In Japan, a clinical Phase III program in general anesthesia has been
    successfully completed.

    Development for ICU sedation beyond 24 hours is planned following
    successful completion of development in procedural sedation and general
    anesthesia. A pediatric development plan has been agreed with the FDA and
    will be implemented following development of Remimazolam for adult
    patients.

    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 Pendopharm,
    respectively. In the U.S. and EU, PAION focuses on the attractive
    opportunity of an own commercialization or co-commercialization.

    About PAION
    PAION AG is a publicly listed Specialty Pharmaceutical Company
    headquartered in Aachen (Germany) with operations in Cambridge (United
    Kingdom) and New Jersey (USA). PAION's lead substance, Remimazolam, is an
    intravenous ultra-short-acting anesthetic in Phase III clinical development
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    DGAP-News PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY - Seite 2 DGAP-News: PAION AG / Key word(s): Research Update PAION SUCCESSFULLY COMPLETES PATIENT RECRUITMENT IN PHASE III STUDY WITH REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY 11.04.2016 / 20:56 The issuer is solely responsible for the content of …