Cambridge (United Kingdom) and Indianapolis (United States) – Acacia Pharma (EURONEXT: ACPH), 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, announces its results for the year ended 31 December 2019 and outlook 2020.
 
Acacia Pharma owns global rights to BARHEMSYS® for the prevention and treatment of postoperative nausea & vomiting (PONV) 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 H2 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).
 
Regulatory highlights

• US Food and Drug Administration (FDA) approved the New Drug Application (NDA) for BARHEMSYS® for the prevention and treatment of postoperative nausea & vomiting (PONV) in adult patients on 26 February 2020.
• Product portfolio expanded through in-licensing of Byfavo™ (remimazolam), an ultra-short-acting and reversible sedative/anesthetic designed for use during invasive medical procedures, from Cosmo Pharmaceutical N.V. in January 2020. The PDUFA date for Byfavo is 5 April 2020.

Commercial launch

• US launch planned in H2 2020.
• Core US commercial infrastructure established and key sales representatives identified. Minimum 30 field managers planned to be in place prior to launch.

Management changes

• Mike Bolinder appointed as Chief Executive Officer on 1 August 2019. Mike brings significant commercial expertise with more than 17 years of highly relevant experience in the pharmaceutical industry. Prior to joining Acacia Pharma, Mike was Head of Marketing and Commercial Strategy for the hospital division of Mallinckrodt Pharmaceuticals. He joined Mallinckrodt upon its acquisition of Cadence Pharmaceuticals, Inc. which commercialised Ofirmev®, a post-operative pain control product promoted to anaesthetists and surgical teams. Previously he worked at Eli Lilly and Company for 11 years in various sales and marketing roles of increasing responsibility across multiple therapeutic areas and on several successful product launches.
• Gary Gemignani appointed as Chief Financial Officer on 29 February 2020. Gary Gemignani’s career in healthcare spans over three decades, including senior management/executive positions at several pharmaceutical and biopharmaceutical companies. Most recently, he served as CFO of Synergy Pharmaceuticals Inc. where he successfully led the sale of this Nasdaq-listed company’s assets to Bausch Health. Previously, he served as CEO and CFO of Biodel Inc., overseeing business and strategic planning, operations and financing activities of the company. During his tenure, Gary successfully led Biodel’s reverse merger with Albireo Ltd and managed several corporate restructurings to strengthen Albireo’s overall financial position. Prior to this, he served in senior and executive financial and operational roles with multiple public and private companies including, Gentium, Novartis and Wyeth. Mr Gemignani started his career at Arthur Andersen & Co.

Finance

• Cash and cash equivalents as at 31 December 2019 of $17.0m
• Balance sheet further strengthened post-year end with €10m ($11.2m) equity investment in January and €10m ($11.2m) loan facility, which became available following BARHEMSYS approval.

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.