Acacia Pharma Group PLC (BR:ACPH) has received a Complete Response Letter (CRL) from the FDA for lead asset BARHEMSYS (repurposed amisulpride) for the management of post-operative nausea and vomiting (PONV). The CRL comes as a surprise as it relates to deficiencies at the contract manufacturers responsible for producing the API. Importantly, we note that the FDA has not requested additional clinical data or trials for BARHEMSYS’s potential approval. We expect Acacia to work with its contract manufacturer and the FDA to discuss the exact requirements to resolve the agency’s concerns. At this point, Acacia expects a quick resolution and maintains a potential launch of BARHEMSYS for PONV rescue in H119. Our valuation is unchanged at €10.9/share.
CRL issued on 5 October PDUFA date
While the CRL issued by the FDA for BARHEMSYS was unexpected, the issues raised do not relate to the safety and efficacy of BARHEMSYS in PONV, but rather to deficiencies that the FDA had identified during a recent pre-approval inspection of the amisulpride API contract manufacturer. This means no further clinical trials or clinical data are required, which is positive. Furthermore, Acacia notes that no inadequacies were noted regarding the purity or stability of the API or the quality of the finished product. While the exact issues are unknown, we expect a resolution and potential approval post-resubmission of the application once the concerns of the agencies have been addressed. If it is deemed a Class 1 resubmission, it implies up to a two-month review period.
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