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Acacia eyes February FDA verdict for refiled nausea drug Barhemsys

Back on track after being turned down twice

FDA

Acacia Pharma’s experimental drug for post-operative nausea and vomiting (PONV) looks back on track, after being turned down twice by the FDA.

The Cambridge, UK company has refiled the marketing application for Barhemsys (intravenous amisulpride) and says the US regulator will give it a rapid review with a proposed action date of 26 February 2020.

Acacia was hit hard after the FDA issued complete response letters (CRLs) for Barhemsys for the prevention and treatment of PONV in October 2018 and May 2019, both voicing concerns about the contract manufacturing organisation making the active ingredient in the drug after an inspection.

As part of the refiling, Acacia has nominated an alternative contract manufacturer to supply amisulpride, which it says has “undergone and passed regular inspections by regulatory authorities for compliance with current Good Manufacturing Practices”. Around 60% of its production is already sold in the US, according to analysts at Edison.

Acacia’s Euronext-listed shares rose almost 3% on news of the new FDA action date, as investors reacted to the positive news about the company’s lead drug candidate.

Edison is expecting a launch in the first half of 2020 now that Barhemsys is confirmed to have the quicker (class 2) resubmission confirmed, and said in a recent research note that the company’s “US sales team is positioning itself for a prompt launch”.

“Our team has worked very hard qualifying a new supplier of amisulpride for our application and I am delighted with how quickly this has been achieved,” said Acacia’s new chief executive Mike Bolinder, who took over the helm of the company from Julian Gilbert at the end of July.

“Given the proven track record of our new supplier, we are very confident of success in this review period and our commercial team is well positioned to launch Barhemsys in the US next year,” he added.

Edison is predicting that Acacia will have to raise around £40m ($49m) in new funding in the first half of 2020 to allow it to proceed with the roll-out, if the approval comes as expected.

The analysts have previously predicted peak sales of Barhemsys could reach around $400m in the US for PONV, with another $110m possible from a follow-up indication in chemotherapy-included nausea and vomiting (CINV).

The CINV product – APD403 – has completed one proof-of-concept and one phase 2 dose-ranging study, and Acacia says it intends to start phase 3 trials after completion of an additional phase 2 study.

Article by
Phil Taylor

26th September 2019

From: Regulatory

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