Utrecht (The Netherlands) and Cambridge (Massachusetts) – Gilde Healthcare company Acacia Pharma (BRU:ACPH), a pharmaceutical company developing and commercializing hospital products for US and international markets, announces that the US Food and Drug Administration (FDA) has accepted its resubmitted New Drug Application (NDA) for BARHEMSYS® (amisulpride injection). FDA has classified the resubmission as Class 2 and has given a Prescription Drug User Fee Act (PDUFA) goal of reviewing and acting on it no later than 26 February 2020.
As part of this process, Acacia Pharma has nominated an alternative contract manufacturer to supply 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 and passed regular inspections by regulatory authorities for compliance with current Good Manufacturing Practices (cGMP).
“Given the proven track record of our new supplier, we are very confident of success in this review period and our commercial team is well positioned to launch BARHEMSYS in the USA next year,”
said Acacia Pharma CEO, Mike Bolinder.
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. The Group 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.
The Group’s lead project, BARHEMSYS™ for post-operative nausea & vomiting (PONV), has generated positive results in four Phase 3 clinical studies. 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, with a US headquarters 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 the company’s website at www.acaciapharma.com
About Gilde Healthcare
Gilde Healthcare is a specialized European healthcare investor managing € 1 billion ($ 1.2 billion) across two fund strategies: venture & growth capital and private equity. Gilde Healthcare’s venture & growth capital fund invests in health tech 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
Gilde Healthcare II is supported by the European Communities Growth and Employment Initiative, MAP – ETF Start-up Facility.