Amarin, the Irish biotech that developed a cardiovascular drug out of refined fish oil, is gearing up for a launch in Europe.
It will be a further validation for a company that has fought back from the brink after an adverse regulatory ruling the United States nearly crippled the business.
Chief executive John Thero has been at the helm through what has been, at times, a bumpy ride with regulators until a multiyear clinical trial finally delivered results that secured widespread access for its only drug, Vascepa, in the United States just over a year ago.
Vascepa – which will be sold as Vazkepa in Europe – reduces harmful blood fats called triglycerides in patients at risk of potentially fatal heart attack or stroke.
The European Medicines Agency's committee on medicinal products for human use (CHMP) has recommended the drug for use by adults who are already being treated with statins. As with the high-profile Covid vaccines, that decision has to be confirmed by the European Commission. That decision is expected in the next six weeks.
Statins
Speaking to The Irish Times, Mr Thero noted that more people in Europe are taking statins than in the United States and that the rate of death from cardiovascular disease is also higher in Europe.
“Lowering cholesterol is good but while statins are good, they lower cardiovascular risk by between 25 per cent and 35 per cent. That of course means there is still a 65-75 per cent risk remaining.
“What we have shown is that, in those high risk patents, we can lower the risk an additional 35 per cent beyond what has been done by the stain. So it is the greatest benefit of any therapy on top of statins that is out there.
“Heart disease is the number one cause of death in most of Europe and it is rare to have a breakthrough in preventative care particularly one with the profile that is as strong as we have for Vazkepa,” Mr Thero said. “So we are looking forward to getting market access and, as soon as we can get it for each country, we will be looking forward to making the drug available in each country.”
There is a population of around 85 million patients across Europe that Amarin feel could benefit from the therapy.
The company has what it describes as “ambitious” plans to expand their operations into 15 European countries over the next two years. The launch will kick off in Germany with the creation of more than 150 jobs.
Pricing
But the challenge of agreeing pricing with each of the states in the EU remains. Ireland has recently released a tranche of money promised in the last budget to fund the rollout of approved drugs that have been logjammed for some time. Others remain in the queue.
Amarin will have to negotiate that same system, though its initial focus will likely be on the bigger health markets of Germany, France, Spain and Italy, as well as Britain.
Mr Thero accepts that getting pricing agreed could take a year or more in some states but the company will focus on building up its teams in countries where it thinks it can get market access first.
He acknowledged that nailing down market access and pricing was a challenge for all medicines but he argues that “we also have to take into account that the cost of debilitating events – like strokes and heart attacks – are very high”.
“Being able to lower those costs presents an opportunity for savings in society.”
He said he was confident that Amarin can prove the cost benefit of its drug for Europe’s stretched health budgets.
And unlike many new generation drugs for very rare conditions and biologics, he said the company’s aim was to introduce Vazkepa in the way that is affordable. In the US, it costs less than $2 a capsule.
“We are trying to, as we did in the US , to introduce Vazkepa in a way that is affordable so it can be used by many people for preventative care. Our hope is to be able to help many people and therefore we need the drug to be affordable and available.”
Amarin has decided to run the operation in Europe directly, employing its own sales teams.
The company is also in the early stages of entering the Asian market, with applications before regulators in China and Hong Kong. However, in Asia, is will manage any rollout in partnership with a local group.
