IRISH BIOPHARMACEUTICAL firm Amarin has estimated that the US market potential for its heart disease drug is in excess of $1 billion a year, with 100 million people worldwide meeting the requirements for treatment by the drug.

It is also optimistic that market exclusivity can be secured for its triglyceride-lowering drug, AMR101.

In a letter to shareholders that was published yesterday, chairman and chief executive Joseph Zakrzewski said he saw an “encouraging path forward” for the company, which focuses on cardiovascular disease.

Amarin hopes to launch AMR101 in 2012, but fears about patent protection have weighed on the company.

However, according to Mr Zakrzewski, the company is now “aggressively pursing a strategy to enhance the proprietary position” of the drug, and in this regard, it has 16 pending patent applications.

Moreover, it is “optimistic” that it will be awarded a US Food and Drug Administration (FDA) five-year new chemical entity marketing exclusivity.

Amarin also plans to seek regulatory exclusivity for AMR101 in Europe, and it believes the lack of regulatory guidelines in both the US and Europe for establishing bioequivalence for generic forms of this type of molecule, “may provide us with added exclusivity protection”.

Market sentiment has also questioned Amarin’s preference for launching the drug itself, but yesterday, Mr Zakrzewski said Amarin is considering three potential paths: partnership, acquisition and self-commercialisation. The chairman and chief executive noting that launching through a third-party has some “obvious appeal provided that the economics are attractive”.

While the US will remain the primary focus of Amarin for the launch of AMR101 during 2012 the company will also give increased focus to select international markets.