Acacia Pharma announces US FDA approval of BARHEMSYS® to treat PONV

Cambridge (United Kingdom) and Indianapolis (United States) – Gilde Healthcare company Acacia Pharma (EURONEXT: ACPH), a hospital pharmaceutical company focused on therapeutic solutions improving the care of patients undergoing significant treatments such as surgery, other invasive procedures, or cancer chemotherapy, announces that the US FDA has approved BARHEMSYS® for the prevention and treatment of Postoperative Nausea and Vomiting in adult patients. An estimated 16 million surgical patients each year in the US suffer from PONV despite receiving prophylaxis. BARHEMSYS is the first and only antiemetic to be approved for the rescue treatment of PONV in patients who have failed prior prophylaxis using current standard of care.

Acacia Pharma owns global rights to BARHEMSYS and intends to directly commercialize the product in the US through its own sales channel, having built critical sales, marketing, medical, and operational infrastructure and capabilities over the past two years. The company plans to launch BARHEMSYS in 2H 2020.

Gilde Healthcare acted as founding investor of Acacia Pharma and supported the company in all subsequent financing rounds including the IPO at Euronext in 2018. Gilde is still the largest shareholder in the listed company (EURONEXT: ACPH).

BARHEMSYS is an intravenous formulation of the selective dopamine D2 and D3 antagonist amisulpride (2.5 mg/mL). The New Drug Application (NDA) submitted by Acacia Pharma for BARHEMSYS, which included four positive Phase 3 studies, contained data gathered from more than 3,300 surgical patients and healthy volunteers. The approval for BARHEMSYS covers the treatment of PONV in patients who have received antiemetic prophylaxis with an agent of a different class or who have not received prophylaxis and the 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 pipeline aims to address.
Acacia Pharma’s lead product, BARHEMSYS® for postoperative nausea and vomiting (PONV), has been approved by the US FDA, with US launch planned for 2H 2020.
Byfavo™ (remimazolam injection), an ultra-short-acting and reversible sedative/anesthetic investigated for use during invasive medical procedures, such as colonoscopy and bronchoscopy, is in-licensed from Cosmo Pharmaceuticals NV for the US market. The NDA for Byfavo has been filed with the US FDA, and the target PDUFA action date is 5 April 2020.
APD403 (intravenous and oral amisulpride), a selective dopamine antagonist for chemotherapy-induced nausea and 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 centered in Indianapolis, IN. The Company is listed on the Euronext Brussels exchange under the ISIN code GB00BYWF9Y76 and ticker symbol ACPH. For more information, visit the company's website at www.acaciapharma.com.

About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing over €1 billion across two fund strategies: venture & growth capital and private equity. Gilde Healthcare's venture & growth capital fund invests in fast growing companies active in medtech, digital health and therapeutics. The venture & growth companies are based in Europe and North America. Gilde Healthcare's private equity fund invests in profitable European lower mid-market healthcare companies with a focus on the Benelux and DACH region. The private equity fund targets healthcare providers, suppliers of medical products and service providers in the healthcare market. For more information, visit the company's website at www.gildehealthcare.com.