Irish firm Amarin confirms heart drug success

Some concern over neutrality of placebo and whether it might have boosted Vascepa data

Amarin, a one-drug Irish company, will discover the market's verdict on its prospects Monday after presenting detailed data on a very successful clinical trial over the weekend.

Shares have already risen sevenfold since top line results of the five-year study, released in September, showed the drug, Vascepa, reduced a variety of heart complications, including chest pain and procedures to clear clogged arteries by 25 per cent.

That was well ahead of expectations and increases the chances that Amarin has a blockbuster therapy on its hands.

Detailed results presented Saturday at the American Heart Association meeting in Chicago look even better. When only the three most feared conditions – death, heart attack and stroke – were considered, patients' risk fell 26 per cent on the drug.

Vascepa also improved patient survival, reducing deaths by cardiac causes by 20 per cent.

However, some medics and analysts are concerned that the use of mineral oil in the placebo given to patients in the trial may have distorted the figures.

The alarm was caused by figure for LDL, known as bad cholesterol, in blood tests. In patients on the placebo, this rose by 10 per cent, compared to between 3 and 4 per cent for patients on Vascepa. The worry is that doctors would not generally expect such readings to change for patients on a placebo.

They question whether mineral oil might have blocked patients ability to absorb statins, effectively worsening their position and making the Vascepa results look better be comparison. All patients in the trial were on such medication.

Addressing the concerns, Amarin chief executive John Thero said: "There is no strong evidence we've seen of biological activity [of mineral oil]. We think it had a minimal effect, if any. There is no perfect placebo. We think we've used the right one for what we're doing."

Another study presented at the Chicago meeting, for BASF’s Omacor, showed a different type of fish oil failed to help the hearts of healthy people, raising questions about whether conflicting scientific research on fish oil stems from different patient groups or differences in the therapies.

Amarin has alway said that a key to its success has been the highly purified nature of its product. Amarin doses at 4mg compared to 1mg in the failed trial.

“Patients who have a serious medical condition should not expect to be getting benefit from a drug that is an omega-3 mixture,” Mr Thero said. “Hopefully some of the myths about what works and what doesn’t work will be alleviated.”

Sales of Vascepa have already risen by as much as 15 per cent since the initial topline results of the trial were published in September, according to reports.

Mr Thero said the company will ask US regulators to expand Vascepa’s prescribing information to include a broader group of patients in the early part of next year. It is currently approved only for certain high-risk patients, which limits its sales potential.

If approved, Vascepa would add another tool for doctors to treat heart disease, which kills 610,000 people a year in the United States, according to the Centers for Disease Control and Prevention.

It 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.

Analysts who follow the company had predicted ahead of the presentation of the detailed trial results that Vascepa could generate more than $1 billion in annual sales by 2023. – Additional reporting Bloomberg

Dominic Coyle

Dominic Coyle

Dominic Coyle is Deputy Business Editor of The Irish Times