Acacia Pharma - NDA resubmission before month-end
Acacia’s interim results highlight the group’s focus on commercialising key asset BARHEMSYS in the US market during 2020. With a new CMO qualified, management plans to resubmit its new drug application (NDA) to the US FDA before end September. If the FDA deems it a Class 2 resubmission, a new PDUFA date would fall in Q120, enabling a launch in H120. The US sales team is positioning itself for a prompt launch. Managing cash burn during the intervening period is essential as we forecast that c £40m will need to be raised in H120 (following approval) to fund operations, with additional future funding dependent on sales execution. With Acacia’s commercial focus concentrated on the US, it has changed its presentation currency from GBP to US$. We will reflect this in our financial model in due course, but retain our previous forecasts (GBP denominated) and valuation of €631m in the interim.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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