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DGAP-News: PAION AG / Key word(s): Miscellaneous
06.10.2020 / 17:23
The issuer is solely responsible for the content of this announcement.


- Licensee Acacia clears final hurdle on path to commercial launch in the U.S.

- BYFAVOTM designated as a Schedule IV medicine by Drug Enforcement Administration

- BYFAVOTM expected to be commercially available in the U.S. before the end of 2020

Aachen (Germany), 06 October 2020 - The Specialty Pharma Company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) reports that Acacia Pharma (Acacia), remimazolam licensee for the U.S., today announced that the U.S. Drug Enforcement Administration (DEA) has designated the procedural sedative BYFAVO(TM) (remimazolam) as a Schedule IV medicine. This designation is the schedule for drugs with a low potential for abuse and low risk of dependence and is consistent with drugs like midazolam and diazepam (Valium(R)).

On 2 July 2020, the U.S. Food and Drug Administration (FDA) granted market approval for BYFAVO(TM) for the induction and maintenance of procedural sedation in adults undergoing procedures lasting up to 30 minutes. Scheduling by DEA represents the final requirement for BYFAVO(TM) to be marketed in the U.S., with launch expected by the end of 2020.

Dr. Jim Phillips, Chief Executive Officer of PAION AG, stated: "BYFAVOTM has now cleared the final hurdle on its path to commercial launch in the U.S. We are very pleased that our partner Acacia can now complete the final preparations of the launch in the U.S."

"We are grateful to DEA for its timely determination of the scheduling of BYFAVOTM and are excited to bring this novel product to the U.S. market," commented Mike Bolinder, Acacia Pharma's CEO. "We will start the process of labeling and packaging our stock of commercial product immediately so that we can make BYFAVOTM available to patients as soon as possible. We anticipate the product being available for sale in the U.S. prior to the end of the year. Our first product, BARHEMSYS(R) (amisulpride injection) for postoperative nausea & vomiting, was launched in August and we are already registering product sales. We are delighted to be able to provide these two medicines to physicians and their patients in the United States."


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 BYFAVOTM) with Acacia Pharma, in Japan (brand name Anerem(R)) with Mundipharma, in China (brand name Ruima(R)) 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.

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).

Ralf Penner
Vice President Investor Relations/Public Relations
Martinstrasse 10-12
52062 Aachen - Germany
Phone +49 241 4453-152

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.

06.10.2020 Dissemination of a Corporate News, transmitted by DGAP - a service of EQS Group AG.
The issuer is solely responsible for the content of this announcement.

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Language: English
Company: PAION AG
Martinstr. 10-12
52062 Aachen
Phone: +49 (0)241-4453-0
Fax: +49 (0)241-4453-100
ISIN: DE000A0B65S3
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich, Stuttgart, Tradegate Exchange
EQS News ID: 1139118

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Last Updated: 06-Oct-2020