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Acacia Pharma Advances Preparations for US Launch of BARHEMSYS®

Second API Supplier for BARHEMSYS® Receives FDA Approval


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.”


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.

About Acacia Pharma

Acacia Pharma is 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. The Company has identified important and commercially attractive unmet needs in these areas that its product portfolio aims to address.

Acacia Pharma's first product, BARHEMSYS® (amisulpride injection) for postoperative nausea & vomiting (PONV), has been approved by the US FDA, with US launch planned for 2H 2020.

BYFAVO™ (remimazolam) for injection, a very rapid onset/offset IV benzodiazepine sedative is approved in the US for use during invasive medical procedures in adults lasting 30 minutes or less, such as colonoscopy and bronchoscopy. Acacia Pharma’s rights to further develop and commercialize BYFAVO are in-licensed from Paion UK Limited pursuant to an assignment from Cosmo Technologies Limited for the US market. US launch is planned for 2H 2020

APD403 (intravenous and oral amisulpride), a selective dopamine antagonist for chemotherapy induced nausea & vomiting (CINV) has successfully completed one proof-of-concept and one Phase 2 dose-ranging study in patients receiving highly emetogenic chemotherapy.

Acacia Pharma is based in Cambridge, UK and its US operations are centred in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.

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Last Updated: 30-Jul-2020