Acacia blossoms on first product approval

Shares of Cambridge, UK-based Acacia Pharma (Euronext: ACPH) rocketed 27.24% to 3.55 euros by mid-morning trading today, as the company announced that the US Food and Drug Administration (FDA) has approved Barhemsys (amisulpride injection) for the prevention and treatment of post-operative nausea and vomiting (PONV) in adult patients, with a US launch planned for later this year.

“The approval of our first product represents a significant milestone in Acacia Pharma’s evolution into an integrated hospital pharmaceutical company with strong development and commercialization capabilities,” commented chief executive Mike Bolinder, adding: “Our goal is for Barhemsys to become established as the new standard of care in the US for the treatment of PONV in patients who have failed standard prophylaxis, the area of highest unmet need. The results of our extensive clinical program also allow us to offer Barhemsys as an option for the prevention of PONV in higher-risk patients and settings, where combination prophylaxis can be valuable. We are on target with our commercial preparations and expect to launch Barhemsys in the second half of this year.”

Barhemsys has not had the smoothest ride to approval, having in October 2018 received a complete response letter from the FDA. The letter identified that deficiencies had been reported during a recent pre-approval FDA inspection of the contract manufacturer of amisulpride, the active pharmaceutical ingredient used in Barhemsys. Following a resubmission, it received a second CRL which identified continuing deficiencies at the contract manufacturer of amisulpride.