Cambridge, UK and Indianapolis, US – 6 November 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 it has resubmitted its New Drug Application (NDA) for BARHEMSYS(TM) (amisulpride injection) to the US Food and Drug Administration (FDA).
On 8 October, the Company announced that it had received a complete response letter identifying deficiencies relating to the pre-approval inspection of the contract facility employed to manufacture amisulpride, the active pharmaceutical ingredient in BARHEMSYS. No defects were noted in the purity or stability of the active ingredient, or in the manufacturing process or quality of the finished product. In addition, no concerns were raised by FDA on any of the clinical or non-clinical data in the application and no further studies or data analyses will be required for approval.
The contract manufacturer has worked closely with the Company to prepare its Corrective and Preventive Action (CAPA) plan to robustly address the outstanding deficiency at its facility. The CAPA has now been submitted to the FDA by the contract manufacturer. As a result of these efforts, Acacia Pharma has resubmitted the NDA for BARHEMSYS. Within 30 days of resubmission FDA will classify it as either Class 1 (review completed within two months of receipt) or Class 2 (review completed within six months of receipt). Further updates in relation to these events will be provided in due course.
“Our contract manufacturer has worked diligently to institute a corrective and preventative action plan that we are confident will rectify the deficiency identified by the FDA. I would like to thank all those involved for their swift actions. We continue to plan for a launch in the first half of 2019.” 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