Irish heart drug company Amarin has secured approval from Canadian authorities to sell its one drug in that market.
The Canadian green light comes just a couple of weeks after US regulators sanctioned the selling of the drug, Vascepa, to a far wider cohort of patients than previously approved.
Amarin can now sell Vascepa to reduce the risk of stroke or heart attack in patients who are already on cholesterol-lowering drugs called statins but are still registering elevated levels of harmful blood fats called triglycerides. The company estimates that the market in the United States alone is more than six million patients.
The drug will be sold in Canada through HLS Therapeutics, which negotiated exclusive rights with Amarin. HLS currently expects Canadian sales of Vascepa to reach between 150 and 250 million Canadian dollars a year.
Regulatory approval
Amarin has already received $7.5 million in payments from HLS to secure the rights to market the drug in Canada and will receive a further $2.5 million as a result of the regulatory approval. The deal with HLS provides for additional milestone payments of more than $50 million.
In the wake of the US approval, Amarin raised its forecast for 2020 sales to somewhere between $650 million and $700 million. That compares to sales of $229 million in 2018 and a figure expected to be close to but under $425 million last year.
The drug has been on sale in the US since 2014, but was approved only for a much more limited group of patients until the Food and Drug Administration decision to widen access in December.
Alleged infringements
Amarin said Vascepa was now approved for widespread use in four jurisdictions – the US, Canada, the United Arab Emirates and Lebanon. The company said it and its commercial partners were currently seeking approval in other jurisdictions, including China, the European Union, the Middle East and North Africa.
Separately, Amarin is gearing up for a major legal action against generic drug manufacturers West-Ward Pharma, Hikma Pharma and Dr Reddy's Labs over alleged infringements of Vascepa patents.
The Irish-headquartered business has already settled similar claims with Teva, one of the largest generics producers, in a move that is likely to block the introduction of generic competition by Teva for Vascepa till 2029. That would give the Irish business a clear nine-year run to establish its product and maximise sales.
A pretrial conference was held the week before Christmas and the trial is due to start in Nevada on January 13th.
