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Acacia finally gets FDA okay for first product Barhemsys

Edison analyst predicts drug could reach $387m at peak

FDA

The long tale of Acacia Pharma’s efforts to bring its post-operative nausea and vomiting (PONV) drug Barhemsys to market is finally over – with a happy ending.

The Cambridge, UK-based company has finally succeeded in getting US Food and Drug Administration (FDA) approval for Barhemsys (intravenous amisulpride) at the third attempt, after earlier rejections for the prevention and treatment of PONV in October 2018 and May 2019.

The green lights comes after Acacia nominated an alternative contract manufacturer for the active ingredient in Barhemsys, after struggles with quality control issues, and after a pre-approval inspection of a new production facility.

Acacia says it will launch the product in the second half of the year and over the last few months has built up its commercial presence in the US, with a headcount of 30 across six regional teams and up to 30 more hires on the way. Shares in the company closed up 15% on the Euronext exchange after the announcement.

Edison analyst Dr Susie Jana said the FDA has granted a broad label to Barhemsys which when combined with its potential for saving costs “should support broad hospital formulary access” and could drive sales to $387m at peak.

The agency has cleared the Barhemsys as a rescue therapy for patients who can’t maintain control of PONV with standard drugs, and it is the first drug to be approved for this indication, according to Acacia.

It can also be used for prophylaxis both as a monotherapy and in combination with existing therapies including 5-HT3 antagonists like ondansetron and granisetron.

Acacia has previously suggested that the rescue therapy segment represents a potential patient population of 16 million people a year in the US, and Edison thinks most of its detailing efforts will go towards that segment initially. All told, the total number of PONV patients per year in the US is estimated at around 30 million.

“PONV remains a major problem for surgical patients and there have been few therapeutic advances over the past 20 years,” commented Professor TJ Gan, chairman of the department of anaesthesiology at Stony Brook University in New York.

“It is often considered by patients to be the most undesirable complication of surgery, even worse than pain [and] it is therefore very welcome to be able to add Barhemsys to the treatment arsenal.”

Edison previously predicted Barhemsys could add another $110m possible to its peak tally if it can add a follow-up indication in chemotherapy-induced nausea and vomiting (CINV).

Meanwhile, the UK company is also preparing for a possible approval by 5 April of ByFavo (remimazolam), an ultra-short-acting and reversible intravenous benzodiazepine sedative/anaesthetic for use during procedural sedation.

It licensed the drug from Cosmo Pharma in a deal that also included a loan and equity investment that has allowed Acacia to build its commercial operations.

Article by
Phil Taylor

28th February 2020

From: Regulatory

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