Cosmo announces United Arab Emirates regulatory approval of GI GENIUS™

Cosmo announces United Arab Emirates regulatory approval of GI GENIUS™

Dublin, Ireland - June 12, 2020 - Cosmo Pharmaceuticals N.V. (SIX: COPN) ("Cosmo") today announced that GI Genius™ has received regulatory approval in the United Arab Emirates. More countries in the Middle East Region are expected to follow in the next months.

GI Genius™ is the first system using artificial intelligence to detect colorectal polyps and is already available in Europe.

Cosmo recently announced very positive results of the first investigator initiated prospective clinical study of its GI Genius™ artificial intelligence endoscopy device. In this trial the system increased adenoma detection rate by an absolute value of 16% from 40.9% in the control arm to 56.9% in the GI Genius™ group. For more information regarding the GI Genius™ investigator initiated trial please visit: https://www.cosmopharma.com/news-and-media/press-releases-and-company-news/2020/200220

The trial required for GI Genius™ registration in the U.S., which commenced earlier this year and was substantially halted due to Covid-19, is now resuming and is expected to last for a further 4-6 months.

Alessandro Della Chà (CEO of Cosmo) commented: "It is very positive to see the GI Genius™ franchise continuing to expand".

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 U.S. 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

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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