PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE FOR REMIMAZOLAM IN ITALIAN HOSPITAL

DGAP-News: PAION AG / Key word(s): Miscellaneous
02.06.2020 / 09:00
The issuer is solely responsible for the content of this announcement.

PAION ANNOUNCES APPROVAL OF COMPASSIONATE USE FOR REMIMAZOLAM IN ITALIAN HOSPITAL

Aachen (Germany), 02 June 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announces that the local Ethics Commitee of the Hospital San Raffaele in Milan/Italy has granted approval for the compassionate use of remimazolam for the use of sedation of five intensive care unit (ICU) patients with COVID-19. After that inital use the treatment might be extended to a wider number of patients at the hospital.

PAION was contacted by the San Raffaele Hospital as to whether remimazolam could be delivered since a shortage of propofol and midazolam due to the coronavirus pandemic occurred. PAION will fulfill the request from the hospital and will deliver the material free of charge.

Dr. Phillips (CEO of PAION AG) commented: "We are pleased to be able to help San Raffaele during the current Covid-19 crisis, and to be able to contribute to the global fight against the pandemic."

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.

In clinical studies, remimazolam demonstrated efficacy and safety in approximately 2,900 volunteers and patients. Remimazolam has received marketing authorization in Japan, and marketing approval applications have been submitted inter alia in the U.S. and in Europe.

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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., licensee Cosmo Pharmaceuticals submitted a New Drug Application for procedural sedation in April 2019, with a PDUFA decision date of 05 July 2020. In China, licensee Yichang Humanwell filed for market approval in procedural sedation in November 2018. 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 results 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. (Cosmo Pharmaceuticals, sublicensed to Acacia Pharma), Japan (Mundipharma), China (Yichang Humanwell), Canada (Pharmascience), Russia/CIS, Turkey and the MENA region
(R-Pharm) as well as South Korea and Southeast Asia (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 developing and aiming to commercialize 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. In Japan, remimazolam was approved for general anesthesia in January 2020. In the U.S., a New Drug Application (NDA) for procedural sedation is under review, with a PDUFA date of 05 July 2020. In China, licensee Yichang Humanwell filed for market approval for remimazolam in procedural sedation in November 2018 and in South Korea, licensee Hana Pharm filed for market approval for remimazolam in general anesthesia 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. Results 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 & critical care by bringing novel products to market to benefit patients, doctors & 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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