27.02.2020 – COSMO Pharmaceuticals N.V.

Cosmo announces that Acacia Pharma Group plc obtains U.S. FDA Approval of BARHEMSYS ®

Cosmo announces that Acacia Pharma Group plc obtains U.S. FDA Approval of BARHEMSYS®

Dublin, Ireland – February 27, 2020 - Cosmo Pharmaceuticals N.V. (SIX: COPN) (“Cosmo”) announced today that Acacia Pharma Group plc (EURONEXT: ACPH) (“Acacia”) has obtained U.S. FDA approval for BARHEMSYS® for the prevention and treatment of PONV (post-operative nausea and vomiting) in adult patients.

In January Cosmo sublicensed its ByFavo™ U.S. rights to Acacia for a €10 million upfront payment in Acacia shares and made a €10 million investment in the company. Cosmo holds 8,994,667 Acacia ordinary shares representing a 14.08% stake in the company acquired at an average cost of €2.22 per share.

When the stake in Acacia was acquired Cosmo also provided financing to fund Acacia’s U.S. expansion by way of €35m in loan facilities of which €10 million can be drawn upon approval of BARHEMSYS® and €25 million can be drawn upon approval of ByFavo™ which has a PDUFA date of 5 April 2020. Cosmo will receive a further €20 million in Acacia ordinary shares upon approval and first sale of ByFavo™.

Alessandro Della Chà, CEO of Cosmo, commented: “We are very pleased with the FDA approval of BARHEMSYS®. This is the second occasion in which we have invested in a company prior to the PDUFA date for a key product and in both cases the products were subsequently approved. We believe that BARHEMSYS® is a great commercial fit with ByFavo™.”

The Acacia press release and presentation in relation to the approval of BARHEMSYS® can be found at the following links:



About Cosmo Pharmaceuticals

Cosmo is a specialty pharmaceutical company focused in treating selected Gastrointestinal Disorders and Endoscopy. The Company’s proprietary clinical development pipeline specifically addresses innovative treatments for IBD, Colonic Infections and 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™ it’s 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


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Niall Donnelly, Chief Financial Officer & Head of Investor Relations

Cosmo Pharmaceuticals N.V.

Tel: +353 1 817 03 70


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