27 July 2020
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.
Forward looking statement
This announcement includes forward-looking statements, which are based on current expectations and projections about future events. These statements may include, without limitation, any statements preceded by, followed by or including words such as “believe”, “expect”, “intend”, “may”, “plan”, “will”, “should”, “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements may and often do differ materially from actual results. These forward-looking statements are subject to risks, uncertainties and assumptions about the Company and its subsidiaries and investments, including, among other things, the development of its business, trends in its operating industry, and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's business, results of operations, financial position, prospectus, growth or strategies and the industry in which it operates. Save as required by law or applicable regulation, the Company and its affiliates expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise. Forward-looking statements speak only as of the date they are made.