Cosmo Pharmceuticals assigns US license agreement for BYFAVOTM (remimazolam) with Paion to Acacia Pharma

Cosmo Pharmceuticals assigns US license agreement for BYFAVOTM (remimazolam) with Paion to Acacia Pharma

Dublin, Ireland - 15 July 2020: Cosmo Pharmaceuticals N.V. (SIX: COPN) today announced the assignment of its US BYFAVOTM (Remimazolam) license agreement to Acacia Pharma with the consent of Paion and mutual release between Cosmo and Paion. The terms of the license agreement remain unchanged but it will now be between Paion and Acacia with Cosmo no longer being a party to the agreement.

Alessandro Della Chà, CEO of Cosmo, said: "This assignment is important in order to allow Acacia to have a direct relationship with Paion. We look forward to continuing to contribute to the success of BYFAVOTM as shareholders of both Acacia and Paion."

Dr. Jim Phillips, CEO of PAION AG, commented: "We are very pleased that we have come to an agreement with Cosmo and Acacia, which will simplify what until now has been a three-party relationship, and going forward we can interact directly with the Acacia team to support commercialisation. With the recent market approval of BYFAVOTM in the US, we are pleased to now be able to have a direct relationship with the end-commercialisation partner. We want to thank Cosmo for their support in the past years and look forward to continuing to work with them as an investor and shareholder."

Mike Bolinder, CEO of Acacia Pharma commented: "We are very pleased to have been assigned the US license to BYFAVOTM following its very recent approval by the US Food and Drug Administration and are grateful for all the support provided by Cosmo. This new direct arrangement with Paion will allow us to better collaborate and access their deep expertise on the benefits of BYFAVOTM as we look to begin the commercialization of this important new product for procedural sedation in adult patients, alongside BARHEMSYS®, in the months ahead."

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 US, licensee Cosmo Pharmaceuticals received market approval in procedural sedation in 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 US (brand name BYFAVOTM) with Acacia Pharma, in Japan (brand name ANEREM®) 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 Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused on developing and commercialising products to treat selected gastrointestinal disorders and improve endoscopy quality measures through aiding the detection of colonic lesions. Cosmo has also developed medical devices for endoscopy and has recently entered into a partnership with Medtronic for the global distribution of GI Genius™ its artificial intelligence device for use in coloscopies and GI procedures. Cosmo has licensed Aemcolo™ to Red Hill Biopharma and is the licensee of BYFAVO™ (Remimazolam) for the US for procedural sedation, which it has sub-licensed to Acacia. For additional information on Cosmo and its products please visit the Company's website: www.cosmopharma.com

Financial calendar

2020 Half-Year Results	July 30, 2020
Investora, Zurich	September 23, 2020

Contact

Niall Donnelly, CFO & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

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Disclaimer

Some of the information contained in this press release contains forward-looking statements. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and that actual results may differ materially from those in the forward-looking statements as a result of various factors. Cosmo undertakes no obligation to publicly update or revise any forward-looking statements.

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This press release does not constitute an "offer of securities to the public" within the meaning of Directive 2003/71/EC of the European Union (the "Prospectus Directive") of the securities referred to in it (the "Securities") in any member state of the European Economic Area (the "EEA"). Any offers of the Securities to persons in the EEA will be made pursuant to an exemption under the Prospectus Directive, as implemented in member states of the EEA, from the requirement to produce a prospectus for offers of the Securities.

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