Statement re Miraxion
November 19 2007 - 11:12AM
UK Regulatory
RNS Number:0300I
Amarin Corporation Plc
19 November 2007
AMARIN ANNOUNCES COMPLETION OF COMPREHENSIVE DATA ANALYSIS FROM PHASE III
HUNTINGTON'S DISEASE PROGRAM
LONDON, United Kingdom, November 19, 2007, Amarin Corporation plc (NASDAQ: AMRN)
("Amarin" or "Company") today announced that management has met with the U.S.
Food and Drug Administration (FDA) following the completion of a comprehensive
data review from its large-scale Phase III studies of Miraxion to treat
Huntington's disease (HD). The FDA indicated that one additional Phase III trial
demonstrating robust results, in conjunction with the confirmatory evidence from
the existing clinical data, may be sufficient clinical data to support a New
Drug Application.
Rick Stewart, Chief Executive Officer of Amarin, commented "We are pleased with
the results of the comprehensive clinical data review and are encouraged by the
outcome of our recent dialogue with the FDA. We are now in discussions with the
Huntington Study Group to determine the optimal design of such a single Phase
III trial. We are also considering whether Amarin will conduct this study itself
or seek a collaborative partner with which to advance Miraxion in Huntington's
disease."
Since the most recent update on Miraxion to treat HD on August 1, 2007, the
Company has continued a comprehensive analysis of all clinical data with its
advisors. This additional analysis supports the preliminary findings, suggesting
a clinical benefit from a longer treatment period for Miraxion.
Positive 12-month results from U.S. Phase III Trial (TREND-HD)
The TREND-HD trial, conducted by the Huntington Study Group in the U.S. and
Canada in 316 patients, was a 6-month, double-blind placebo controlled study
followed by a further 6-month extension period where all patients received 2
grams per day of Miraxion. The primary endpoint was the 6-month change in TMS-4,
a scale that measures motor symptoms. As previously announced on April 24, 2007,
at the 6-month time point, there was no statistically significant difference in
efficacy between the Miraxion group and the placebo group.
Analysis of the 12-month data showed a statistically significant difference in
TMS-4 between the long term Miraxion group (12-months treatment) and those
patients who had switched to Miraxion at 6-months. Treatment codes were not
broken at the switching point so investigators and patients remained blinded to
receipt of Miraxion or placebo in the initial 6-month period. These results
suggest that there is benefit from a longer treatment period with Miraxion and
are consistent with the 24-month open-label data from the earlier 135-patient
trial completed in 2003.
Positive Additional Analysis
A longitudinal analysis, which is a widely accepted and validated alternative
statistical methodology, was applied to all available clinical data as part of
the comprehensive review.
TREND-HD Trial Outcome
The longitudinal methodology was applied to both the 3 and 6-month combined
results as well as the 3, 6, 9 and 12-month combined results. A statistically
significant difference between the Miraxion and placebo groups was identified in
each of the 3-6 month and the 3, 6, 9 and 12-month analyses.
Earlier 135 patient Trial Outcome
In the earlier 135-patient study, the longitudinal analysis showed a
statistically significant difference between Miraxion and placebo in the per
protocol patient groups and, additionally, a greater degree of statistical
significance in the intent to treat genetic sub-group of patients with a CAG< 44
than in the previous analysis.
Analysis was also conducted on the 24-month open label data from the 135-patient
trial, in which patients initially randomized to treatment with placebo had been
switched to Miraxion and treated for 12 months. After switching to Miraxion,
these patients demonstrated an effect of similar magnitude to patients
randomized to treatment with Miraxion at baseline.
About Amarin
Amarin is committed to improving the lives of patients suffering from central
nervous system and cardiovascular diseases. Our goal is to be a leader in the
research, development and commercialization of novel drugs that address unmet
patient needs.
Amarin's CNS development pipeline includes Miraxion for Huntington's disease,
two programs in Parkinson's disease, one in epilepsy and one in memory and
cognition. Amarin is initiating a series of cardiovascular preclinical and
clinical programs to capitalize on the known therapeutic benefits of essential
fatty acids in cardiovascular disease. Amarin also has a proprietary lipid-based
technology platform for the targeted transport of molecules through the liver
and/or to the brain that can be leveraged in a wide range of disease
applications for its own product pipeline or with potential partners.
Amarin has its primary stock market listing in the U.S. on NASDAQ ("AMRN") and
secondary listings in the U.K. and Ireland on AIM ("AMRN") and IEX ("H2E"),
respectively.
For press releases and other corporate information, visit the Amarin website at
http://www.amarincorp.com. Information on our website does not form part of this
press release.
Contacts:
Amarin +44 (0) 207 907 2442
Rick Stewart Chief Executive Officer
Alan Cooke President and Chief Financial Officer
investor.relations@amarincorp.com
Investors:
Lippert/Heilshorn & Associates, Inc. +1 212 838 3777
Anne Marie Fields
Bruce Voss +1 310 691 7100
Media:
Powerscourt +44 (0) 207 250 1446
Rory Godson
Sarah Daly
Disclosure Notice:
The information contained in this document is as of November 19, 2007. 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: risks relating to the Company's ability to maintain its Nasdaq
listing (including the risk that the Company may not be able to achieve
compliance with the Nasdaq minimum bid price and/or other continued listing
criteria within the required timeframe or at all and the risk that the Company
may not be able to successfully appeal a Nasdaq delisting determination); 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;
Amarin's ability to maintain sufficient cash and other liquid resources to meet
its operating requirements; general changes in International and US generally
accepted accounting principles; growth in costs and expenses; and the impact of
acquisitions, divestitures and other unusual items. 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, 2006, filed with the
SEC on March 5 2007, Amarin's statutory annual report for the year ended 31
December, 2006 furnished on a Form 6-K to the SEC on May 9, 2007 and in its
Reports of Foreign Issuer on Form 6-K furnished to the SEC.
Ends
This information is provided by RNS
The company news service from the London Stock Exchange
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