Amarin drug hits goals, may rival Glaxo's Lovaza

Mon Nov 29, 2010 6:01am EST

* High-dose AMR101 cut triglyceride levels by 33 percent

* Amarin brings forward U.S. filing date for drug to 2011

* AMR101 a competitor for GSK's best-selling Lovaza

LONDON, Nov 29 (Reuters) - Amarin Corp Plc's (AMRN.O) closely watched heart pill AMR101 hit its targets in a pivotal clinical study on Monday, giving the Nasdaq-listed Irish firm ammunition to take on GlaxoSmithKline's (GSK.L) popular Lovaza.

Both drugs contain omega-3 fatty acids, the heart-protecting chemicals found in fish oil, and are designed to treat patients with very high levels of triglycerides, a blood fat that contributes to heart disease alongside cholesterol.

In the Phase III study, involving 229 patients, those on a 4-gram dose of AMR101 experienced a 33 percent decrease in blood triglyceride levels after 12 weeks compared to patients given a placebo, Amarin said.

Those on 2 grams saw a 20 percent decrease in the trial, which studied patients with greater than 500mg of triglycerides per decilitre of blood.

Importantly, taking AMR101 did not increase levels of low-density lipoprotein, or "bad cholesterol". Increased bad cholesterol is a side effect of Lovaza, which is less highly purified than AMR101.

Lovaza -- supplied to GSK by Norway's Pronova BioPharma ASA PRON.OL -- is currently the only omega-3 derived prescription drug approved in Europe and the United States.

GSK's sales of Lovaza sales jumped 31 percent to 450 million pounds ($702 million) in 2009 and the drug is expected to sell around $1 billion by 2011, according to consensus forecasts compiled by Thomson Reuters Pharma.

In future, Amarin hopes to take a chunk of that business with its new competitor and the group has brought forward plans to file AMR101 for U.S. regulatory approval to 2011. Previously, it had indicated a filing in 2012.

Amarin aims to seek a marketing partner for AMR101 and is currently in talks with a number of potential companies. (Reporting by Ben Hirschler; Editing by Jon Loades-Carter)

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