Acacia Pharma - BARHEMSYS NDA resubmitted to FDA
Acacia Pharma has resubmitted a New Drug Application (NDA) to the FDA for its lead asset BARHEMSYS (repurposed amisulpride) for the management of post-operative nausea and vomiting (PONV). While the original complete response letter (CRL) received was unexpected, the issues related to deficiencies at the contract manufacturers responsible for producing the active pharmaceutical ingredient (API) and not to any other part of the application or the API itself. Within 30 days of this resubmission, the FDA will determine whether the application constitutes a Class 1 (up to two months) or Class 2 (up to six months) review. Acacia maintains that a potential launch of BARHEMSYS for PONV rescue is possible in H119. It has reported a 9M18 net loss of £10.0m, driven by preparation activities for the commercial launch of BARHEMSYS. We value Acacia at €602m or €11.3/share.Acacia Pharma Group Plc. Acacia Pharma Group PLC is a United Kingdom-based company specialized in the pharmaceutical industry. The pharmaceutical group focuses on the development and commercialization of new nausea and vomiting treatments for surgical and cancer patients. Its pipeline includes BAREMIS, an intravenous formulation of amisulpride, which is a selective dopamine antagonist that has completed phase 3 clinical development for the prophylaxis and treatment of Postoperative nausea and vomiting (PONV), and APD403, which is based on the selective dopamine antagonist amisulpride and it is being developed as an intravenous injection for cancer patients to be administered immediately before chemotherapy to prevent acute chemotherapy-induced nausea & vomiting ( CINV).
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