Interview – Decision time for Acacia as US filing approaches
If all goes to plan in the next few months Acacia could soon become a rare beast in the UK – a small drug developer in possession of an internally developed, US-approved product. Baremsis, the company’s anti-sickness treatment, will be filed with US regulators in the next six months, chief executive Julian Gilbert tells EP Vantage.
The collapse of the company’s IPO last year means that cash remains a pressing issue, though Mr Gilbert says there is enough in the bank to complete the US registration process for Baremsis. However, with ambitions to launch the drug itself in the US and further indications needing late-stage examination, Acacia's decision on the path forward is looming.
“All options are on the table,” Mr Gilbert says. “We have a valuable product and will consider all options that allow us to realise that value.”
Take two at an IPO?
Partners will be considered, he says, as well as re-igniting flotation plans. “We could go fairly quickly, having done all the work, although I’m not sure we would consider it with the current market conditions.”
On top of jittery equity markets, UK companies hoping to go public have not been helped by the collapse of Circassia. The high-profile allergy player raised a huge £200m ($334m) in 2014 at 310 pence, but is now trading at 99.50 pence.
Acacia was targeting £150m in its IPO, which would have seen the development of Baremsis, a repurposed version of the dopamine antagonist amisulpride, completed in post-operative nausea and vomiting (PONV) and chemotherapy-induced nausea and vomiting (CINV), and US infrastructure established to launch the product.
The CINV indication remains in phase II – a large 342-patient trial yielded positive data last year. PONV was pushed forward first in a pivotal programme that could see the drug launched with a broad label, in both prophylactic and treatment settings.
Two phase III studies in combination with standard emetics have been completed successfully, and last week the first of two trials of Baremsis as a rescue medication yielded positive results.
Acacia claims that Baremsis could become the first antiemetic with a treatment claim following failed prophylaxis and a combination use claim in the prophylaxis setting.
Meeting a need
It will need differentiators in the market – the space is highly genericised, and pressure on drug prices is mounting. However, Mr Gilbert insists that payers recognise the need for new options.
“There are good drugs available, but 30-40% of patients still get PONV. Our drug will fit in where there is a failure of standard of care, or on top of standard of care. Our market research confirms this is acceptable for formulary positions,” he says.
The presence of effective generic options has not put off other smaller players. Heron last week won approval of a sustained-release formulation of granisetron, Sustol, while Tesaro launched Varubi, an NK-1 antagonist, late last year. Both are only approved in the chemotherapy setting, but this is where Acacia is heading, albeit with a different class.
Any potential partner casting an eye over this space will be keeping a close eye on the launches of Sutol and Varubi. Consensus forecasts from sellside analysts look typically optimistic, given the problems in this space.
The fact that both Tesaro and Heron pushed through trials and onto the market alone suggests that this is the future that also awaits Acacia in the US, in the short term at the very least.
|Outlook for the branded anti-emesis space – sellside consensus|
|Product||Pharma class||Company||2022e sales ($m)||Status|
|Sustol (granisetron)||5-HT3 antagonist||Heron Therapeutics||427||Approved|
|Varubi (rolapitant)||NK-1 antagonist||Tesaro||404||Marketed|
|Syndros (dronabinol)||Cannabinoid||Insys Therapeutics||280||Approved|
|Emend (aprepitant)||NK-1 antagonist||Merck & Co/Ono||281||Marketed|
|HTX-019 (aprepitant)||NK-1 antagonist||Heron Therapeutics||86||Pre-filing (generics)|
|Aloxi (palonosetron)||5-HT3 antagonist||Otsuka Holdings||79||Marketed|
|Zhiruo (palonosetron)||5-HT3 antagonist||Sino Biopharmaceutical||65||Marketed|