26 September 2019
Acacia Pharma Announces New BARHEMSYS® PDUFA Target Date of 26 February 2020
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
Cambridge, UK and Indianapolis, US – 26 September 2019: Acacia Pharma Group plc (“Acacia Pharma” or “the Company”), 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).
“We are very pleased the FDA has accepted the resubmission of our application and granted us a Q1 PDUFA date, as we anticipated. Our team has worked very hard qualifying a new supplier of amisulpride for our application and I am delighted how quickly this has been achieved. 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.
Acacia Pharma Group plc
Mike Bolinder, CEO
Christine Soden, CFO
+44 1223 919760
Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Shabnam Bashir, David Dible
+44 20 7638 957
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. www.acaciapharma.com
Forward looking statement
This announcement includes forward-looking statements, which are based on current expectations and projections about future events. These statements may include, without limitation, any statements preceded by, followed by or including words such as “believe”, “expect”, “intend”, “may”, “plan”, “will”, “should”, “could” and other words and terms of similar meaning or the negative thereof. Forward-looking statements may and often do differ materially from actual results. These forward-looking statements are subject to risks, uncertainties and assumptions about the Company and its subsidiaries and investments, including, among other things, the development of its business, trends in its operating industry, and future capital expenditures and acquisitions. By their nature, forward-looking statements involve risk and uncertainty because they relate to future events and circumstances. Any forward-looking statements reflect the Company's current view with respect to future events and are subject to risks relating to future events and other risks, uncertainties and assumptions relating to the Group's business, results of operations, financial position, prospectus, growth or strategies and the industry in which it operates. Save as required by law or applicable regulation, the Company and its affiliates expressly disclaim any obligation or undertaking to update, review or revise any forward-looking statement contained in this announcement whether as a result of new information, future developments or otherwise. Forward-looking statements speak only as of the date they are made.