Amarin files new drug application for AMR 101 in Europe

HD Lighthouse Contributing Editor's Comment: 

The Lighthouse has been following ethyl-EPA as a potential treatment for Huntington's Disease for nearly a decade now.  Over time, the rights to this formula were sold by Laxdale to Amarin and the supplement has been variously termed  LAX-101, AMR 101 and Miraxion.

There have been a number of promising studies but ethyl-EPA has not yet completed a successful Phase III trial with results that would be likely to satisfy the FDA. 

Today, however, Amarin announced that they have filed an application with the European Medicines Agency (EMEA) to market AMR 101 as a treatment for Huntington's Disease.  They are basing the application on the results of the TREND-HD study that was conducted in the U.S. and Canada as well as a study of cerebral atrophy (See TREND-HD and Ethyl EPA reduces cerebral atrophy ).  The application has been accepted for review.

The Lighthouse will continue to follow developments with AMR 101 (ethyl-EPA).

-- Marsha L. Miller, Ph.D.
Posted to the HDL: 04-08-2009

Amarin’s Marketing Authorization Application For Amr101 To Treat Huntington’s Disease Accepted For Review By EMEA

Amarin

DUBLIN, Ireland, April 8, 2009 – Amarin Corporation plc (NASDAQ: AMRN) today announced that the European Medicines Agency (EMEA) has accepted for review the Company's Marketing Authorization Application (MAA) for AMR101 (ultra-pure ethyl-EPA) in patients with Huntington’s disease.

Thomas Lynch, Chairman and Chief Executive Officer of Amarin, commented “We are pleased to have our EMEA filing for AMR101 in Huntington’s disease accepted for review as it is a disorder of great unmet medical need. Given the excellent safety and tolerability profile of AMR101, and the significant impact it demonstrated in a Phase 3 trial on slowing the disease progression over 12 months, it could offer patients a much needed advance in treatment.”

Mr. Lynch added “While we are now focusing our resources and development activities on our cardiovascular disease programs, pursuing marketing approval for AMR101 to treat Huntington’s disease in Europe remains a potentially valuable opportunity for the Company.”

The application is based on clinical data which includes results from the Company’s multi-centre, double-blind, placebo-controlled Phase 3 study of AMR101 in 316 patients with Huntington’s disease conducted in the U.S. and Canada (TREND-HD). Amarin announced in 2007 the results of its Phase 3 studies conducted in U.S, Canada and Europe in which AMR101 did not show a statistically significant effect at six months, but did however show a significant treatment effect at twelve months, in the 192 patients who completed a six month open label extension to the TREND-HD study. These results were consistent with the positive effect of AMR101 over longer treatment periods of 12 and 24 months in earlier studies conducted by Amarin.

The filing also included data from a recently published magnetic resonance imaging (MRI) study investigating the comparative effects of AMR101 and placebo on the cerebral pathology of patients with Huntington’s disease. The data show a reduced rate of cerebral atrophy in patients receiving AMR101, with the most significant impact in those areas implicated in the aetiology of Huntington’s disease, including the head of the caudate nucleus.

While no further studies have been conducted since the results of the Phase 3 studies were announced in 2007, the filing did include additional detailed analysis of the data from these Phase 3 studies which further supports the benefit of AMR101 in Huntington’s disease over longer treatment periods.

AMR101 has been designated as an Orphan Medicinal Product in the European Union for the treatment of Huntington’s disease, which, if approved, entitles the drug to ten years of market exclusivity for the approved indication. Amarin has also secured patents for the use of AMR101 to treat Huntington’s disease, with expiry dates ranging from 2020 to 2023.

Source: press release