PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE PROGRAM FOR REMIMAZOLAM IN BELGIUM

DGAP-News: PAION AG / Key word(s): Miscellaneous
03.08.2020 / 15:36
The issuer is solely responsible for the content of this announcement.

PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE PROGRAM FOR REMIMAZOLAM IN BELGIUM

Aachen (Germany), 03 August 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the Federal Agency for Medicines and Health Products in Belgium (FAMHP) has granted approval for the compassionate use of remimazolam, an ultra-short-acting benzodiazepine sedative/anesthetic. Under the program, remimazolam can be used for sedation of intensive care unit (ICU) patients with COVID-19, and as a substitute for current standard of care in general anesthesia for which there are currently shortages due to the coronavirus pandemic. The use is limited to physicians who have experience with remimazolam.

PAION was contacted by the Belgian regulatory authority as to whether remimazolam could be delivered nationwide because of the current shortages of propofol and midazolam due to the coronavirus pandemic. PAION will fulfill requests from hospitals as quickly and as much as possible and will deliver the material initially free of charge.

Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "In the current exceptional situation triggered by the coronavirus pandemic, we are pleased to be able to do our part in enabling patients to get the treatment they need. Remimazolam has shown in numerous clinical trials that it could potentially be a safe and effective alternative to the currently used anesthetics, and we look forward to providing this drug to physicians and patients under this compassionate use program."

Compassionate use is allowed under EU law under strict conditions and refers to the use of medicines that are expected to help patients with life-threatening, long-lasting or seriously disabling illnesses but that are not yet authorized or licensed. Within a compassionate use program, medicines can be made available to patients if sufficient indication of the efficacy and safety of the medicinal product exists.

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About remimazolam
Remimazolam is an ultra-short-acting intravenous benzodiazepine sedative/anesthetic. In the human body, remimazolam is rapidly metabolized to an inactive metabolite by tissue esterases and is not metabolized by cytochrome-dependent hepatic pathways. Like other benzodiazepines, remimazolam can be reversed with flumazenil to rapidly terminate sedation or anesthesia if necessary. In clinical studies, remimazolam demonstrated efficacy and safety in around 2,900 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.

In Japan, licensee Mundipharma received market approval in general anesthesia in January 2020. In the U.S., former licensee Cosmo Pharmaceuticals received market approval in procedural sedation in July 2020. In China, licensee Yichang Humanwell received market approval in procedural sedation in July 2020. In South Korea, licensee Hana Pharm filed for market approval in general anesthesia in December 2019. In Europe, PAION submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in procedural sedation in November 2019 and topline data of an EU Phase III trial in general anesthesia are expected in the second half of 2020.

In addition to procedural sedation and general anesthesia, based on positive Phase II study results, ICU sedation is another possible indication for remimazolam.

Remimazolam is partnered in the U.S. (brand name BYFAVO^TM) with Acacia Pharma, in Japan (brand name Anerem^(R)) with Mundipharma, in China with Yichang Humanwell, in Canada with Pharmascience, in Russia/CIS, Turkey and the MENA region with R-Pharm, and in South Korea and Southeast Asia with Hana Pharm. For all other markets including parts of the EU, remimazolam is available for licensing.

About PAION
PAION AG is a publicly listed specialty pharmaceutical company focused on developing and commercializing innovative drugs for 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. Remimazolam is partnered in multiple territories outside of Europe. Remimazolam was approved in the U.S. and China for procedural sedation in July 2020 and in Japan for general anesthesia in January 2020. In South Korea a market application for remimazolam in general anesthesia was filed in December 2019.

In Europe, PAION is seeking approval of remimazolam for general anesthesia and for procedural sedation. PAION submitted a Marketing Authorization Application (MAA) for procedural sedation in November 2019. The topline data of a Phase III trial in general anesthesia are expected in the second half of 2020.

PAION's mission is to be a leading specialty pharmaceutical company in the fields of anesthesia and critical care by bringing novel products to market to benefit patients, doctors & other stakeholders in healthcare.

PAION is headquartered in Aachen (Germany) with an additional site in Cambridge (United Kingdom).

Contact
Ralf Penner
Vice President 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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