Acacia Pharma - BARHEMSYS NDA refiling Q319, launch in Q120
Following guidance from the US FDA, Acacia Pharma has now outlined the regulatory pathway for its lead asset, BARHEMSYS, and plans to resubmit the new drug application (NDA) in Q319. This could enable a launch in H120 if approved by the FDA. Ongoing deficiencies with Acacia’s chosen contract manufacturing organisation (CMO), which led to two complete response letters (CRL), have resulted in the appointment of a new CMO. With increased visibility on the strategy, we have reintroduced our previously withdrawn forecasts and adjusted our launch timelines for BARHEMSYS in the US. We now forecast a launch in H120 (previously H119). We have also reduced our cost expectations in 2019 as Acacia delays its marketing operations. We now value Acacia at €631m.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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