Amarin to seek European approval for heart drug Vascepa

Irish drug company Amarin will seek European approval for its cardiovascular drug Vascepa before the end of the year.

The drug is in the process of seeking broader FDA approval in the US as well, following clinical trial results last year which showed its fish-oil drug dramatically cut the incidence of heart attack and strokes in high-risk patients.

Until now,it has been approved only for the treatment of patients with very high levels of blood fats – indicators of cardiovascular risk – as a treatment to reduce those levels, but without making any claims on cardiovascular events.

Chief executive John Thero said the company was "hoping to have submitted in Europe sometime towards the end of the year". Amarin, which is based in Dublin but operates largely in the United States, has yet to decide whether it will manage the European rollout in-house or through partnerships with other companies.

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‘Death benefits’

Citing the 25 per cent reduction in risk of an adverse cardiovascular event – such as a heart attack or stroke – and a 20 per cent reduction in deaths among high-risk patients, Mr Thero said: “You don’t even see those death benefits with statins. It is rare to see a reduction in these outcome studies in death.

“And we have more recently shown that not only do we reduce the first occurrence of a cardiovascular event but, even if someone has had a heart attack, we help to prevent the second occurrence, a third occurrence. So essentially, over a five-year period, we have one fewer cardiovascular event for every six patients treated. And that’s a number I’ve not seen before,” he said, noting that the equivalent number for statins is around one in 45.

The company said it has seen a strong increase in prescribing of Vascepa by both cardiologists and endocrinologists, as well as GPs, since its clinical trial results were published.

“In the first four months after we had the new data, we had more new physicians prescribing the product than we had in the previous nine months on aggregate,” said Mr Thero.

Bullish expectations

But he cautioned against overly bullish expectations against the company’s target for sales this year of $350 million.

“We don’t yet have an [expanded] label for the product and our sales force, two-thirds of it is brand new, and we only have one reported quarter at this point,” Mr Thero said. “That quarter did go better than expected, but it is only one quarter . Our guidance is for 50 per cent greater growth over the prior year.

“Each quarter last year got better [in sales] and we would expect each quarter this year to get better,” he said. “I do really think of this year as a step [in the company’s development]. It’s sort of that second phase and it is the third phase that really excites.

One in three adults have some risk for cardiovascular disease and we want them to be asking their doctors about it

“From the beginning, we recognised that what we needed was a label approved for cardiovascular risk prevention and it is [now] right around the corner. And that’s really where things begin.”

Mr Thero said an expanded permission on its label would see a further significant increase in its sales force and, for the first time, would allow the company to start promoting the drug directly to consumers for the first time as a therapy that can help prevent heart attacks and strokes.

“One in three adults have some risk for cardiovascular disease and we want them to be asking their doctors about it,” he said.

Cardiovascular disease is also the single biggest cause of death in Ireland, accounting for up to 10,000 deaths a year, according to the Irish Heart Foundation. That is one-third of all deaths, it says, and one in five of all premature deaths.