Acacia Pharma Advances Preparations for US Launch of BARHEMSYS®

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 July 2020: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), announces that the US Food and Drug Administration (FDA) has approved of a second supplier for the active pharmaceutical ingredient (API) for BARHEMSYS^® (amisulpride injection). BARHEMSYS was approved for the treatment and prevention of PONV in the US in February 2020.

The approval significantly increases the Company’s commercial product stock levels ahead of the US launch of BARHEMSYS. The Company anticipates the approval of a second supplier will support its ability to provide a continuous, high-quality product supply to meet the anticipated ongoing demand.

“We are very pleased to have received approval from the FDA for our second supplier of API for BARHEMSYS as we continue to make good progress with our preparations for its US launch,” commented Mike Bolinder, Acacia Pharma’s CEO. “We believe there will be strong demand for BARHEMSYS as US healthcare institutions seek to address surgical backlogs created by the Coronavirus crisis. The strengthening of our supply chain and increase in our available commercial inventory will be important in helping us meet that demand, providing our customers with consistent and timely access to BARHEMSYS for their patients.”

About BARHEMSYS^®

BARHEMSYS^® is a low dose intravenous formulation of the selective dopamine D₂ and D₃ antagonist amisulpride, which Acacia Pharma has developed and protected for the management of PONV.

BARHEMSYS^® is indicated in adults for:

• treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis; and
• prevention of PONV either alone or in combination with an antiemetic of a different class.

www.BARHEMSYS.com