Acacia Pharma Announces US FDA Approval of BARHEMSYS (amisulpride) for the Treatment and Prevention of Postoperative Nausea and Vomiting (PONV)

• BARHEMSYS is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed prior prophylaxis using current standard of care^1,2
   
• An estimated 16 million surgical patients each year in the US suffer from PONV despite receiving prophylaxis³
   
• BARHEMSYS is also approved for the prevention of PONV, either alone or in combination with an antiemetic of a different class
   
• Conference call scheduled for 10:00 am CET, Thursday 27 February

             
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.

Cambridge, UK and Indianapolis, US – 27 February 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a hospital pharmaceutical company focused on the development and commercialization of new products aimed at improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy, announces that the US Food and Drug Administration (FDA) has approved BARHEMSYS (amisulpride injection) for the prevention and treatment of PONV in adult patients.

“The approval of our first product represents a significant milestone in Acacia Pharma’s evolution into an integrated hospital pharmaceutical company with strong development and commercialization capabilities,” commented Mike Bolinder, Acacia Pharma’s CEO. “I would like to thank the Acacia Pharma team and stakeholders that have delivered this new treatment option for the millions of adult surgical patients each year suffering from, or at risk of, PONV. Our goal is for BARHEMSYS to become established as the new standard of care in the US for the treatment of PONV in patients who have failed standard prophylaxis, the area of highest unmet need. The results of our extensive clinical program also allow us to offer BARHEMSYS as an option for the prevention of PONV in higher-risk patients and settings, where combination prophylaxis can be valuable. We are on target with our commercial preparations and expect to launch BARHEMSYS in the second half of this year.”