ACACIA PHARMA ANNOUNCES BARHEMSYS(TM) PDUFA DATE OF 5 MAY 2019
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 - 7 December 2018: Acacia Pharma Group plc ("Acacia Pharma" or "the Company"), a pharmaceutical company developing and commercialising hospital products for US and international markets, announces that the US Food and Drug Administration (FDA) has accepted its resubmission of the New Drug Application (NDA) for BARHEMSYS(TM) (amisulpride injection) as a complete response, addressing the deficiencies identified in the 5 October complete response letter. 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 5 May 2019. The Company continues to plan for a launch in the first half of 2019.
"We are confident in our NDA resubmission for BARHEMSYS and are unwavering in our commitment to provide this new treatment option to surgical patients, their physicians and healthcare providers," said Dr Julian Gilbert, CEO of Acacia Pharma.
Acacia Pharma Group plc
Julian Gilbert, CEO
Christine Soden, CFO
+44 1223 919760
Citigate Dewe Rogerson (Financial PR)
Mark Swallow, Shabnam Bashir, David Dible
+44 20 7638 9571
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(TM) 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 and its US operations are centred 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
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