Amarin shares hit by ruling on generic drugs

Victory by Teva and Par in US case raises concern over prospects for cholesterol drug

Shares in Irish drug firm Amarin have been hit by a US court ruling favouring generic pharmaceutical groups in the area where it operates.

Teva Pharmaceuticals and Par Pharmaceutical won an appeal in their bid to sell a generic version of the cholesterol medication Lovaza in the US.

The US court of appeals for the federal circuit reversed a lower court decision because one patent held by BASF’s Pronova unit had been made publicly accessible and another had expired.

The ruling hit shares of Amarin, with the stock falling as much as 10 per cent before recovering slightly to end the week 8.5 per cent weaker on $6.60. Amarin has been trading at roughly half its 12-month high of $14.30 in recent weeks. Lovaza, sold in Europe as Omacor, is a pharmaceutical-grade fish oil drug designed to lower blood fats in patients at risk of heart attack. It had sales of $1.02 billion (€767 million) in the US last year, where it is sold by GlaxoSmithKline.

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Amarin has developed a fish-oil rival, Vascepa, which it says is more effective and has no side effects, unlike Lovaza. However, it has to date failed to persuade the US Food and Drug Administration to grant it new chemical entity status, which would give it added protection against generics.

The ruling in the case that was originally taken by Pronova in April 2009 can be challenged in the US supreme court. – (Reuters/Bloomberg)