JAPAN PATENT OFFICE GRANTS DOSING PATENT FOR REMIMAZOLAM IN JAPAN
- Patent protection until 2033 in the Japanese market
- Grant further strengthens the remimazolam patent portfolio
Aachen, 13 October 2017 - PAION AG, a Specialty Pharma Company (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8), today announces that a dosing patent for remimazolam has been granted in Japan by the Japan Patent Office. The patent named "Method for administering hypnotic/sedative agent" was published under Patent No. JP 6199869.
The claims of the patent cover the intravenous administration of remimazolam for the induction and maintenance of general anesthesia, which is another indication for which remimazolam has the potential to provide major advantages over existing medications.
Dr. Wolfgang Söhngen, CEO of PAION AG, commented: "Our efforts to expand our patent portfolio are increasingly paying off. This patent strengthens the overall exclusivity of our lead compound remimazolam in Japan until 2033."
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic that has already shown positive results in clinical Phase III trials. 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.
During clinical studies, remimazolam demonstrated efficacy and safety in over 1,500 volunteers and patients. Data so far indicate that remimazolam has a rapid onset and offset of action combined with a favorable cardio-respiratory safety profile.
Remimazolam is currently in the final stage of clinical development for procedural sedation in the U.S. After completion of the ongoing development, the implementation of a pediatric development plan already agreed with the FDA is planned. A full clinical development program for general anesthesia was completed in Japan, and a Phase II study in general anesthesia was completed in the EU. Based on the positive results of the Phase II study, development for ICU sedation beyond 24 hours is another attractive indication.
Remimazolam is partnered in the U.S., Canada, China, Russia (CIS), Turkey, the MENA region, and South Korea with Cosmo Pharmaceuticals, Pharmascience (Pendopharm), Yichang Humanwell, R-Pharm, TR-Pharma and Hana Pharm, respectively. For all other markets, remimazolam is available for licensing.
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 which is in the final stage of clinical development for use in procedural sedation in the U.S. Currently, PAION is mainly focusing 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. A full clinical development program for general anesthesia was completed in Japan and PAION is preparing filing in Japan. In the EU, PAION is currently planning to continue the clinical development program. Development of remimazolam in the indication intensive care unit (ICU) sedation is also part of the longer term life-cycle plan for remimazolam.
PAION is headquartered in Aachen (Germany) with a further site in Cambridge (United Kingdom).
PAION's vision is to become an acknowledged "PAIONeer" in sedation and anesthesia.
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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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