Acacia Pharma plans to resubmit the BARHEMSYS® NDA in Q3 2019
Cambridge, UK and Indianapolis, US - Acacia Pharma, a pharmaceutical company developing and commercialising hospital products for US and international markets, announces receipt of the official Type A meeting minutes from the US Food and Drug Administration (“FDA”) relating to the Company’s BARHEMYS® (amisulpride injection) New Drug Application (“NDA”). At this meeting, Acacia Pharma agreed with FDA a plan to resubmit the NDA, designating a new supplier of amisulpride, the active pharmaceutical ingredient (“API”) in BARHEMSYS.
The new supplier has extensive experience both in manufacturing amisulpride and in producing APIs to the standards required by FDA. The supplier has also successfully undergone regular inspections by regulatory authorities for compliance with current Good Manufacturing Practices (“cGMP”), most recently by FDA in September 2018 when its facility was rated “No Action Indicated” (“NAI”), the best possible outcome. Approximately 60% of the supplier’s production is currently destined for the US market, including the APIs for a number of products for intravenous and other parenteral use. Acacia Pharma began qualifying the new amisulpride supplier in October 2018.
“We are pleased with the constructive and productive meeting we had with FDA and now have a clear path to resubmit the BARHEMSYS NDA in the third quarter of this year. We expect a six-month review by the FDA, which would give a projected PDUFA (Prescription Drug User Fee Act) date in the first quarter of 2020,” said Dr Julian Gilbert, CEO of Acacia Pharma. “The supplier has an excellent track record of manufacturing API for FDA-approved products and, importantly, of passing cGMP inspections, including an FDA inspection less than a year ago. Our commercial team is continuing pre-launch activities and we look forward to bringing BARHEMSYS to the market as soon as possible.”
About Acacia Pharma
Acacia Pharma is a hospital pharmaceutical company focused on the development and commercialisation of new nausea & vomiting treatments for surgical and cancer patients. Acacia Pharma has identified important and commercially attractive unmet needs in nausea & vomiting and has discovered two product candidates based on the same active ingredient, amisulpride, to meet those needs.
Acacia Pharma's lead project, BARHEMSYS™ for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. A New Drug Application (NDA) for BARHEMSYS is under review by the US Food and Drug Administration (FDA). Its sister project, APD403 for chemotherapy induced nausea & 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 under ISIN code GB00BYWF9Y76 and ticker symbol ACPH. For more information, visit company's website at www.acaciapharma.com
About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing €1 billion across two business lines: a venture & growth capital fund and a lower mid-market buy-out fund. Gilde Healthcare's venture & growth capital fund invests in medtech, digital health and therapeutics. The portfolio companies are based in Europe and North America. Gilde Healthcare's lower mid-market buy-out fund invests in profitable European healthcare services companies with a focus on the Benelux and DACH-region. The portfolio consists of healthcare providers, suppliers of medical products and other service providers in the healthcare market. For more information, visit company's website at www.gildehealthcare.com
Gilde Healthcare II is supported by the European Communities Growth and Employment Initiative, MAP – ETF Start-up Facility.