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Acacia Pharma

H119 launch remains on track for BARHEMSYS

Flash note | Pharmaceutical & healthcare | 07 Dec 2018

Acacia Pharma has announced that the FDA has accepted its revised New Drug Application (NDA) for BARHEMSYS and classified it as a Class 2 resubmission. In the revised NDA, Acacia, along with its manufacturing partner, has addressed the deficiencies identified in the 5 October Complete Response Letter (CRL). As this is a Class 2 resubmission (with a six-month total review time), the FDA has now set a Prescription Drug User Fee Act (PDUFA) goal of reviewing and acting on it, of no later than 5 May 2019. Acacia continues to expect to launch BARHEMSYS in H119. We retain our valuation of Acacia at EUR 602m or EUR 11.3/share.

Acacia Pharma

BARHEMSYS NDA resubmitted to FDA

Update | Pharmaceutical & healthcare | 07 Nov 2018

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 GBP 10.0m, driven by preparation activities for the commercial launch of BARHEMSYS. We value Acacia at EUR 602m or EUR 11.3/share.

Acacia Pharma

FDA issues CRL for BARHEMSYS

Update | Pharmaceutical & healthcare | 10 Oct 2018

Acacia Pharma 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 EUR 10.9/share.

Acacia Pharma

Raising the BAR in PONV

Initiation | Pharmaceutical & healthcare | 07 Sep 2018

Acacia Pharma is focused on bringing antiemetic drugs to the US hospital setting for unmet needs in post-operative nausea and vomiting (PONV) and chemotherapy-induced nausea and vomiting (CINV). We expect FDA approval of Acacia’s lead product, BARHEMSYS (repurposed amisulpride), for the management of PONV by its 5 October 2018 PDUFA date. In the near term, Acacia will concentrate on the US commercial opportunity by expanding its sales and marketing infrastructure. We anticipate US launch of BARHEMSYS in Q219 for PONV ‘rescue treatment’ and expect broadening of use for PONV prophylaxis in subsequent years. We value Acacia Pharma at EUR 579m or EUR 10.9 per share.