UPDATE 2-Amarin drug challenges Glaxo’s Lovaza, stock soars

* 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

* Amarin shares surge 58 percent

(Adds latest shares, analyst reaction)

By Ben Hirschler

LONDON, Nov 29 (BestGrowthStock) – Amarin Corp Plc’s (AMRN.O: )
closely watched heart pill AMR101 hit targets in a pivotal
clinical study on Monday, giving the Nasdaq-listed Irish company
ammunition to take on GlaxoSmithKline Plc’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.

Shares in Amarin surged 58 percent to $5.60 in early trade,
reflecting the importance of the product to the company, which
made a net loss of $59 million in 2009.

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 with patients given
a placebo, Amarin said.

Those on 2 grams saw a 20 percent decrease in the trial,
which studied patients with greater than 500 mg of
triglycerides per decilitre of blood. A sub-group of patients
with triglyceride levels above 750 mg/dl had a 45 percent
reduction when given the higher dose of 4g.

Importantly, taking AMR101 did not increase levels of
low-density lipoprotein (LDL), or “bad cholesterol”, in the
study. Increased bad cholesterol is a side effect of Lovaza,
which is less highly purified than AMR101.

Ritu Baral, an analyst with Canaccord Genuity who rates
Amarin stock a “buy”, said the clinical results were “knockout”
and the lack of LDL effect was “very impressive”, suggesting
AMR101 had a superior safety profile to its rival Lovaza.

EYEING $1 BILLION SALES

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.

“We believe that these results and the overall profile of
AMR101 position the drug candidate to be best in class in this
market,” Amarin CEO Joseph Zakrzewski said in a statement.

Amarin aims to seek a marketing partner for AMR101 and is in
talks with a number of potential companies.

The company is also conducting a second Phase III study
looking at AMR101 in patients with triglyceride levels of 200 to
500 mg/dl, which is due to report next year.
(Editing by Jon Loades-Carter and David Holmes)

UPDATE 2-Amarin drug challenges Glaxo’s Lovaza, stock soars