Irish business Amarin wins US approval for heart drug

A SMALL Irish drug development business has won US approval for a new drug to reduce the risk of stroke and heart attack. Analysts suggest Amarin’s Vascepa could have annual sales of more than $1 billion by 2017.

Amarin chairman and chief executive Joe Zakrzewski said the company anticipated a commercial launch for the drug early next year. “This is an exciting time for Amarin and its stakeholders and for all those who have worked so hard over the last several years to make this approval a reality,” he said in a conference call shortly after the approval was announced late on Thursday.

“We continue to consider three potential paths for the marketing and sale of the product: an acquisition of Amarin, a strategic collaboraiton or self-commercialisation.”

Potential suitors include Astrazeneca, Pfizer and Abbott Labs.

The potential blockbuster is essentially a highly purified form of Omega 3 fish oil. It has been approved by the US Food and Drug Administration for the treatment of patients with very high levels of triglycerides.

Triglycerides are blood fats stored from food and then released in the body as energy. At normal levels they present little problem but at elevated levels, they are seen as increasing the risk of heart disease.

Amarin has secured approval for treating people with “very high triglycerides – levels above 500 milligrams/decilitre.

The drug, previously known as AMR101, was found in a phase II “Marine” trial to be effective in significantly reducing levels of the dangerous blood fats in such patients. Significantly, it did so without increasing the levels of low density lipoprotein, sometimes known as “bad cholesterol”. That is an issue for the only competing therapy in the market – GlaxosmithKline’s Lovaza.

Mr Zakrzewski said the company was very happy with the label agreed with the regulators.

Dr Manus Rogan, whose Fountain Healthcare Partners led a $70 million fundraising for Amarin in 2009, said the company was “delighted to have played a role” in its success.

“In October 2009, Amarin was within two weeks of bankruptcy,” he said. The fundriaising led by Fountain supported the two phase III trials – Marine and Anchor. “This resulted in a NDA [new drug applicaiton] submission and ultimately FDA approval yesterday.

“A very important drug is now approved for cardiovascular patients. This is clearly a multibillion-dollar product that will rival a Lipitor or Crestor in terms of sales.”

Amarin has not yet succeeded in securing regulatory approval for a wider patient populaton with triglyceride levels of between 200mg/dl and 500mg/dl, depsite finding in the Anchor trial that it was effective in reducing levels by 21.5 per cent in this population.

Approval for this group would, the company said previously, increase the target patient population tenfold to 40 million in the United States alone.

It has also not yet secured “new chemical entity” status from the FDA, which would give it patent protection for longer. A ruling on this application is expected by August 17th.