Amarin Appoints Medpace as CRO for Two Phase 3 Cardiovascular Trials

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Mon Oct 19, 2009 8:35am EDT

DUBLIN--(Business Wire)--
Amarin Corporation plc (NASDAQ:AMRN) today announced that it has executed an
agreement with Medpace, Inc. (`Medpace`), a leading Contract Research
Organization (CRO) with expertise in conducting clinical trials in
cardiovascular and metabolic disease, to engage their services in the execution
of its Phase 3 clinical trials with AMR101 in patients with very high
triglyceride levels (the AMR101 MARINE Study) and mixed dyslipidemia. 

Dr. Doogan, Interim Chief Executive Officer of Amarin, commented "Following
extensive due diligence on several global CROs, we selected Medpace based on
their expertise in conducting cardiovascular and metabolic studies and their
knowledge of the regulatory environment relevant to this program. We were also
impressed by their international reach, an important requirement given that one
of the Phase 3 trials with AMR101 will be conducted across a number of
international regions including the U.S." 

Dr. David Orloff, Executive Director of Regulatory Affairs at Medpace, commented
"We are pleased to be working with Amarin on the Phase 3 development of AMR101
for hypertriglyceridemia and mixed dyslipidemia. As many as 28 million people in
the U.S. have elevated blood triglyceride levels, a major risk factor for
cardiovascular morbidity and mortality. AMR101, an ultra-pure, prescription
grade ethyl-EPA product, offers the potential to be a novel, safe and effective
therapy for this condition." 

As previously announced, Amarin has secured agreements from the U.S. Food and
Drug Administration (FDA) through the Special Protocol Assessment (SPA) process
for both of the Phase 3 trials. The trials are expected to commence shortly,
report top line data in 2011 with the New Drug Application (NDA) expected to be
filed with the FDA not later than 2012. 

The Phase 3 AMR101 MARINE Study will be a multi-center, placebo-controlled,
randomized, double-blind, 12-week study to evaluate the efficacy and safety of 2
grams and 4 grams of AMR101 in patients with fasting triglyceride levels of ≥500
mg/dL. 

The Phase 3 mixed dyslipidemia trial will be a multi-center, placebo-controlled,
randomized, double-blind, 12-week study to evaluate the efficacy and safety of 2
grams and 4 grams of AMR101 in patients with high triglyceride levels of ≥200
mg/dL and <500 mg/dL who are on statin therapy. This trial is aimed at
potentially broadening the label for AMR101 to position it as "best-in-class" in
the prescription Omega-3 market in the U.S as well as to show its potential as
an effective combination therapy with established statin therapies. 

About AMR101

AMR101 is an ultra-pure ethyl ester of eicosapentaenoic acid (ethyl-EPA).
Numerous independent studies have demonstrated the safety, tolerability and
efficacy of ethyl-EPA in lowering plasma triglycerides in patients with high
triglyceride levels of varying degrees of severity. In Japan, an ethyl-EPA
prescription product has been approved for the treatment of hyperlipidemia and
has been on the market for over 18 years. 

Amarin has previously investigated AMR101 in central nervous system (CNS)
disorders in several double-blind, placebo-controlled studies, including Phase 3
trials in Huntington`s disease. Over 900 patients have received AMR101 in these
studies, with over 100 receiving continuous treatment for one year or more. In
all studies performed to date, AMR101 has shown a very good safety profile. 

About Hypertriglyceridemia and Mixed Dyslipidemia

Hypertriglyceridemia refers to a condition in which patients have high blood
levels of triglycerides and is recognized as an independent risk factor for
cardiac disease. Mixed dyslipidemia refers to a condition in which patients have
a combination of two or more lipid abnormalities including elevated
triglycerides, low high-density lipoprotein (HDL) cholesterol, and elevated
low-density lipoprotein (LDL) cholesterol and is believed to affect more than 34
million people in the U.S. alone. Both hypertriglyceridemia and mixed
dyslipidemia are components of a range of lipid disorders collectively referred
to as dyslipidemia. The overall dyslipidemia population in the U.S. is believed
to be in excess of 100 million. 

About Medpace

Medpace, Inc. is an international drug development services company providing
comprehensive clinical research support to the pharmaceutical and biotechnology
industries and is primarily focused in late phase drug development, particularly
in the cardiovascular and metabolic diseases area. Medpace has conducted trials
involving a number of well known cardiovascular drugs on the market today.
Medpace was established in 1992, has operations in over 40 countries outside the
U.S., and globally employs over 1000 people. Medpace was recently rated as #1
CRO in the 2009 U.S Investigator Site Survey conducted by "CenterWatch", a well
regarded trade publication for the drug development industry. 

About Amarin

Amarin is a clinical-stage biopharmaceutical company with a focus on
cardiovascular disease. The Company`s lead product candidate is AMR101, a
prescription grade Omega-3 product comprising not less than 96% ultra-pure ethyl
eicosapentaenoic acid (EPA), which is entering Phase 3 clinical trials for the
treatment of hypertriglyceridemia and mixed dyslipidemia under Special Protocol
Assessment (SPA) agreements with the U.S. Food and Drug Administration (FDA).
Amarin also has next-generation lipid candidates under evaluation for
preclinical development. Amarin recently established its research and
development headquarters in Mystic, Connecticut with an experienced research and
development team. Amarin`s programs capitalize on its lipid science expertise
and the known therapeutic benefits of Omega-3 products in treating
cardiovascular disease. 

Amarin has a number of non-core programs for partnering in the area of central
nervous system (CNS) disorders, including Huntington`s disease, myasthenia
gravis and Parkinson`s disease. Amarin is listed in the U.S. on the NASDAQ
Capital Market ("AMRN"). For more information please visit www.amarincorp.com. 

Disclosure Notice

The information contained in this document is as of October 19, 2009. Amarin
assumes no obligation to update any forward-looking statements contained in this
document as a result of new information or future events or developments. This
document contains forward-looking statements about Amarin's products in
development that involve substantial risks and uncertainties. You can identify
these statements by the fact that they use words such as "will", "anticipate",
"estimate", "expect", "project", "forecast", "intend", "plan", "believe" and
other words and terms of similar meaning in connection with any discussion of
future operating or financial performance or events. Among the factors that
could cause actual results to differ materially from those described or
projected herein are the following: Amarin's ability to maintain sufficient cash
and other liquid resources to meet its operating and debt service requirements;
growth in costs and expenses; risks relating to the Company's ability to
maintain its Nasdaq listing; the success of Amarin's research and development
activities; whether and when Amarin will be able to enter into and consummate
strategic collaborations with respect to its products or product candidates on
acceptable terms; and the success with which developed products may be
commercialized. A further list and description of these risks, uncertainties and
other matters can be found in Amarin's Form 20-F for the fiscal year ended
December 31, 2007, filed with the SEC on May 19, 2008 and Amarin`s Form 20-F/A
for the fiscal year ended December 31, 2007 filed with the SEC on September 24,
2008.

Amarin
+353 (0)1 669 9020
Thomas Lynch, Chairman
or
Dr. Declan Doogan, Interim Chief Executive Officer
or
Alan Cooke, President, Chief Operating Officer and Chief Financial Officer
or
Darren Cunningham, EVP Strategic Development and Investor Relations
investor.relations@amarincorp.com

Copyright Business Wire 2009

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