Amarin Corporation
plc (NASDAQ: AMRN) announced that the Company recently met with
officials at the U.S. Food and Drug Administration (FDA) to discuss the
Company's plans to develop AMR101 for the treatment of
hypertriglyceridemia. Following these discussions, the Company is
proceeding to Phase 3 with AMR101 in hypertriglyceridemia.
Dr. Declan Doogan, Head of Research and Development of Amarin,
commented: "The meeting with the FDA was very successful as it gives us a
clear path forward for the program. We are particularly pleased that we can
proceed to Phase 3."
Thomas Lynch, Chairman and Chief Executive Officer of Amarin, added:
"Over the past year we have assembled a highly experienced team of
cardiovascular experts to develop AMR101 for this significant indication.
Our initial objective of designing the Phase 3 program and obtaining FDA
feedback has been achieved. Having completed our recent financing, we now
look forward to conducting the Phase 3 program."
AMR101 is an ultra-pure ethyl ester of eicosapentaenoic acid
(Ethyl-EPA). Amarin has collected a substantial body of data on AMR101 to
date. 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 a year or more. In all studies performed to date, AMR101 has
shown a very good safety profile.
Hypertriglyceridemia refers to a condition in which patients have high
blood levels of triglycerides and is associated with increased levels of
heart disease. It is one component 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, with
over 10 million of those diagnosed with hypertriglyceridemia.
Numerous 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 high
triglycerides and has been on the market for seventeen years. Data from
Amarin's Huntington's disease trials indicate that AMR101 lowers
triglycerides in patients with elevated baseline levels.
About Amarin
Amarin is a biopharmaceutical company focused on improving the lives of
patients suffering from cardiovascular and central nervous system (CNS)
diseases. Amarin's cardiovascular programs, including AMR101 for
hypertriglyceridemia, capitalize on the known therapeutic benefits of
essential fatty acids in cardiovascular disease. Amarin's CNS development
pipeline includes programs in myasthenia gravis, Huntington's disease,
Parkinson's disease, epilepsy and memory. Amarin is listed in the U.S. on
the NASDAQ Capital Market ("AMRN").
Disclosure Notice
The information contained in this document is as of July 22, 2008.
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 financial condition, results of operations, business prospects and
products in research 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; the success of Amarin's
research and development activities; decisions by regulatory authorities
regarding whether and when to approve Amarin's drug applications, as well
as their decisions regarding labeling and other matters that could affect
the commercial potential of Amarin's products; the speed with which
regulatory authorizations, pricing approvals and product launches may be
achieved; the success with which developed products may be commercialized;
competitive developments affecting Amarin's products under development; the
effect of possible domestic and foreign legislation or regulatory action
affecting, among other things, pharmaceutical pricing and reimbursement,
including under Medicaid and Medicare in the United States, and involuntary
approval of prescription medicines for over-the-counter use; Amarin's
ability to protect its patents and other intellectual property; claims and
concerns that may arise regarding the safety or efficacy of Amarin's
product candidates; governmental laws and regulations affecting Amarin's
operations, including those affecting taxation; risks relating to the
Company's ability to maintain its Nasdaq listing; general changes in
International Financial Reporting Standards; and growth in costs and
expenses. 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.
Amarin Corporation Plc
amarincorp