Acacia Pharma announces the submission and validation of the marketing authorization request for BARHEMSYS® (Amisulpride injection) on the main European markets
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Cambridge, UK and Indianapolis, US – September 29, 2021: Acacia Pharma Group plc (“Acacia Pharma” or the “Company”) (EURONEXT: ACPH), a commercial-stage biopharmaceutical company focused on the development and commercialization of new 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 (MA) for BARHEMSYS® (amisulpride injection) has been submitted, validated and is currently undergoing formal review in major European markets. The review process is expected to be completed by the third quarter of 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 and vomiting (PONV) and became commercially available in August 2020.
The MAA submission includes data from four positive phase 3 studies with BARHEMSYS, including the first randomized controlled trial ever to show the success of treatment of active PONV in patients who have failed previous prophylaxis. More than 3,300 surgical patients and healthy volunteers have been enrolled in the BARHEMSYS clinical development program.
“BARHEMSYS was successfully launched in the United States last year through our own commercial infrastructure and we are now making good progress in making it available in Europe for the millions of surgical patients who suffer from PONV each year” commented Mike Bolinder, CEO of Acacia Pharma. “We own the worldwide rights to BARHEMSYS and, as we have stated, are pursuing a partnership strategy to bring the product to market outside the US market. We are working diligently to advance international licensing agreements ahead of the product’s planned European approval in 2022. ”
PONV is a common complication of surgery, occurring in about 30% of surgical patients and up to 80% of high-risk patients. It is associated with the use of anesthetic gases and opioid analgesics and is particularly common following gynecological, abdominal, breast, eye and ear operations, especially those lasting an hour or more. PONV has been classified 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, alone or in combination with an antiemetic of a different class
Acacia Pharma Group plc
Mike Bolinder, CEO
Gary Gemignani, Chief Financial Officer
+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 management of patients undergoing important treatments such as surgery, other invasive procedures or cancer chemotherapy. The Company has identified significant and commercially interesting unmet needs in those areas that its product portfolio aims to meet.
Acacia Pharma’s first product, BARHEMSYS® (Amisulpride injection) is available in the United States for the management of postoperative nausea and vomiting (PONV).
PARFAVO® (remimazolam) for Injection, a very rapid acting / compensating IV benzodiazepine sedative is approved in the United States for use in invasive adult medical procedures lasting 30 minutes or less, such as colonoscopy and bronchoscopy. BYFAVO is licensed from Paion UK Limited for the US market.
APD403 (Intravenous and Oral Amisulpride), a selective dopamine antagonist for chemotherapy-induced nausea and vomiting (CINV) has successfully completed a proof of concept and phase 2/3 dosing study in patients receiving chemotherapy highly emetic.
Acacia Pharma is headquartered in the US in Indianapolis, IN and its R&D operations are centered in Cambridge, UK. The Company is listed on the Euronext Brussels stock exchange under the ISIN code GB00BYWF9Y76 and the stock symbol ACPH.
This announcement includes forward-looking statements, which are based on current expectations and projections regarding future events. These statements may include, but are not limited to, statements preceded, followed or including words such as “believe”, “expect”, “intend”, “may”, “plan”, ” will ”,“ should ”,“ could ”and other words and terms with similar meaning or the negative thereof. Forward-looking statements can differ materially from actual results and often do. These forward-looking statements are subject to risks, uncertainties and assumptions regarding the Company and its subsidiaries and investments, including, among others, the development of its business, trends in its operating industry and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risks and uncertainties as they relate to future events and circumstances. Any forward-looking statement reflects the Company’s current view with respect to future events and is subject to risks relating to future events and to other risks, uncertainties and assumptions relating to the business, results of operations, financial situation, prospectus, growth or strategies of the Group and the industry in which it operates. Except as required by applicable law or regulation, the Company and its affiliates expressly disclaim any obligation or commitment 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 on which they are made.
1. Gan TJ, et al. Anal Anesthetic. 2014; 118 (1): 85-113