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
Credit Suisse Global Healthcare Conference, London
March 3-4, 2020
Jefferies Equity Linked Conference 2020
March 26, 2020
Full Year Results 2019, Zurich
April 3, 2020
Annual General Meeting, Amsterdam
May 28, 2020
Jefferies Healthcare Conference, London
June 2-4, 2020
Niall Donnelly, Chief Financial Officer & Head of Investor Relations
Cosmo Pharmaceuticals N.V.
Tel: +353 1 817 03 70
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.
This communication is not an offer of securities of any issuer. Securities may not be offered or sold in the United States absent registration or an exemption from the registration requirement of the US Securities Act of 1933.
This press release constitutes neither an offer to sell nor a solicitation to buy securities and it does not constitute a prospectus within the meaning of article 652a and/or 1156 of the Swiss Code of Obligations or a listing prospectus within the meaning of the listing rules of the SIX Swiss Exchange or any similar document. The offer will be made solely by means of, and on the basis of, a securities prospectus to be published. An investment decision regarding the securities to be publicly offered should only be made on the basis of the securities prospectus.
This press release is made to and directed only at (i) persons outside the United Kingdom, (ii) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the “Order”), and (iii) high net worth individuals, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order. Any person who is not a relevant person should not act or rely on this press release or any of its contents.
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.