29 September 2021
Acacia Pharma Announces Submission and Validation of Marketing Authorization Application for BARHEMSYS® (amisulpride injection) in Major European Markets
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 – 29 September 2021: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a commercial stage biopharmaceutical company focused on developing and commercializing novel products to improve the care of patients undergoing serious medical treatments such as surgery, invasive procedures, or cancer chemotherapy, announces that its Marketing Authorization Application (MAA) for BARHEMSYS® (amisulpride injection) has been submitted, validated and is now under formal review in major European markets. The review process is expected to be completed by Q3/2022.
BARHEMSYS was approved in February 2020 by the Food and Drug Administration (FDA) for use in the United States to prevent and treat postoperative nausea & vomiting (PONV) and became commercially available in August 2020.
The MAA submission includes data from four positive Phase 3 studies investigating BARHEMSYS, including the first ever randomized, controlled trial to show successful treatment of active PONV in patients who have failed prior prophylaxis. More than 3,300 surgical patients and healthy volunteers were enrolled in the BARHEMSYS clinical development program.
“BARHEMSYS was successfully launched in the US last year via our own commercial infrastructure and we are now making good progress to making it available in Europe for the many millions of surgical patients who suffer from PONV each year,” commented Mike Bolinder, Acacia Pharma’s CEO. “We own global rights to BARHEMSYS and, as we have stated, are pursuing a partnership strategy for commercializing the product outside the US market. We are working diligently to progress international licensing agreements ahead of the product’s anticipated European approval in 2022.”
PONV is a common complication of surgery, occurring in approximately 30% of surgical patients and up to 80% of high-risk patients. It is associated with the use of anesthetic gases and opioid painkillers and is particularly common following gynecological, abdominal, breast, eye, and ear operations, especially those lasting an hour or more. PONV has been ranked as the most undesirable of all surgical complications in some patient surveys, even worse than pain.1
BARHEMSYS is a selective dopamine-2 (D2) and dopamine-3 (D3) receptor antagonist, 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
• prevention of PONV, either alone or in combination with an antiemetic of a different class
Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, CFO
+44 1223 919760 / +1 317 505 1280
MEDiSTRAVA Consulting (Financial PR)
Frazer Hall, David Dible, Mark Swallow
+44 20 7638 9571
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) is available in the US for the management of postoperative nausea & vomiting (PONV).
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. BYFAVO is in-licensed from Paion UK Limited for the US market.
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 2/3 dose-ranging study in patients receiving highly emetogenic chemotherapy.
Acacia Pharma has its US headquarters in Indianapolis, IN and its R&D operations are centred in Cambridge, UK. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH.
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.
1. Gan TJ, et al. Anesth Analg. 2014;118(1):85-113