Gilde Healthcare company Acacia Pharma announces marketing authorization application for BARHEMSYS® in Europe - Gilde Healthcare

Gilde Healthcare company Acacia Pharma announces marketing authorization application for BARHEMSYS® in Europe

September 29, 2021
Utrecht, The Netherlands, Cambridge, UK & Indianapolis, US

Acacia Pharma (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.”

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. For more information, please visit www.acaciapharma.com.

About Gilde Healthcare

Gilde Healthcare is a specialized healthcare investor with $1.8 billion under management across two fund strategies: Venture&Growth and Private Equity. The firm operates out of offices in Utrecht (The Netherlands), Frankfurt (Germany) and Cambridge (United States). Gilde Healthcare Venture&Growth invests in innovative companies active in (Bio)pharmaceuticals, Healthtech and Medtech. The portfolio of the Venture&Growth fund is balanced with fast growing life science companies from Europe and North America. For more information, please visit: www.gildehealthcare.com.

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