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February 13, 2017

Acacia Pharma announces positive results from its fourth and final pivotal trial of Baremsis™ for the rescue treatment of PONV

Cambridge, UK – Acacia Pharma Group Ltd (“Acacia Pharma”), the supportive care company developing products for US and international markets, announces positive results from its fourth and final pivotal Phase 3 study investigating BAREMSIS™ (amisulpride injection, formerly APD421) for the rescue treatment of patients who develop post-operative nausea & vomiting (PONV), despite having received prior antiemetic prophylaxis.

Dr Julian Gilbert, Acacia Pharma’s CEO commented: “We are delighted with these results demonstrating that BAREMSIS is safe and effective at rescuing patients who suffer PONV despite having received prior prophylaxis with standard anti-emetics. No other anti-emetic has a specific label for treating this significant unmet need and we intend to position BAREMSIS as the drug of choice for treating the 30-40% of surgical patients who suffer PONV despite prior prophylaxis, as well as for combination prophylaxis in high-risk patients.”

Acacia Pharma has now completed four pivotal Phase 3 studies of BAREMSIS successfully, all meeting their primary endpoint, and these will form the basis of the efficacy and safety package which the Company aims to submit to the US FDA as part of its New Drug Application (NDA) in 1H 2017. The Company will seek a broad and unique approval for BAREMSIS for the rescue treatment and prophylaxis of PONV, alone and in combination.

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