Amarin Provides Business Update and Announces Implementation of Reverse Stock Split
18 Janvier 2008 - 1:47PM
PR Newswire (US)
LONDON, January 18 /PRNewswire-FirstCall/ -- Amarin Corporation plc
(NASDAQ:AMRND) today announced that, at a General Meeting held
yesterday, its shareholders approved a 1 for 10 reverse split of
each of its Ordinary Shares. The reverse split became effective as
of the close of business yesterday, January 17, 2008. Thomas Lynch,
Amarin Chairman and Chief Executive Officer, commented "We are very
pleased to report that over 95% of the votes cast by our
shareholders approved the one-for-ten reverse stock split. We have
made good progress in recent months expanding our management team
and broadening our pipeline and look forward to executing on our
strategy which we believe will drive shareholder value in 2008."
Under customary Nasdaq practice, with effect from today, January
18, 2008, and for a period of 20 trading days, a "D" will be
appended to Amarin's Nasdaq ticker symbol and during that period
Amarin's Nasdaq ticker symbol will appear as "AMRND". Pipeline
Update Through 2007, the Company embarked upon a program of
broadening its development pipeline with the objective of having
multiple late stage programs with an appropriate balance of
portfolio risk. This was facilitated by the achievement of a number
of important milestones. Firstly, the completion of a comprehensive
analysis of the 12-month data from the US Phase III trial of
Miraxion (AMR101) in Huntington's disease (HD) showing a
statistically significant benefit with Miraxion over longer periods
of treatment, and the corresponding feedback from the U.S. Food and
Drug Administration (FDA). Amarin also conducted a thorough
analysis and re-configuration of its existing pipeline from which
the Company's cardiovascular initiative was launched, leveraging
Amarin's proprietary expertise and intellectual property in lipid
science to target, with a potential partner, billion dollar market
opportunities such as triglyceride lowering and dyslipidemia. In
addition, the Company's pipeline offering was expanded further
through the acquisition of Ester Neurosciences (Ester). Ester's
lead product, EN101, an AChE-R mRNA inhibitor, currently in Phase
IIa clinical development, represents an important therapeutic
approach to treat myasthenia gravis, a debilitating neuromuscular
disease. An interim analysis of this Phase IIa study suggests EN101
may have superior efficacy, longer duration of action, and a more
favorable side effect profile and dosing regimen, as compared with
current first line treatment. The acquisition also provides Amarin
with access to a platform messenger RNA (mRNA) silencing technology
which targets the cholinergic pathway, and a promising preclinical
program in neurodegeneration and inflammation. Amarin also
successfully progressed its oral apomorphine candidate through a
series of Phase I pharmacokinetic studies and is currently planning
a final Phase I study before commencing Phase II studies later this
year. This novel sublingual formulation would offer Parkinson's
disease patients an improved alternative to the currently available
injectable formulation of apomorphine that is often associated with
the formation of painful swellings at the site of administration.
Amarin also progressed its other programs, with AMR101 for age
associated memory impairment (AAMI) now in a Phase II study and
both nasal lorazepam for epilepsy seizures and AMR103 for
Parkinson's disease successfully advanced in preclinical studies.
Amarin believes that it has created a pipeline which balances risk
between New Chemical Entities (NCE's) and improved versions of
existing drugs addressing specific limitations or unmet medical
needs, with candidates in both early and late stage development.
During 2008, Amarin targets conducting five Phase II trials and,
with a partner, one Phase III trial, providing a basis for
potentially strong results-driven news flow. The following table
represents Amarin's current development pipeline and corresponding
2008 objectives. Program Indication Status 2008 Objectives
/Candidate Key Programs Miraxion Huntington's - Two Phase - Publish
disease III trials 12-month Phase (AMR101 / completed III data
ultra-pure ethyl-EPA) - One - Secure US additional partner Phase
III trial required - Commence final Phase III trial with a partner
AMR101 Cardiovascular - Clinical - Progress (ultra-pure program
with ongoing clinical ethyl-EPA) and AMR101 program derivatives
commenced late 2007 - Obtain guidance from FDA on design of
triglyceride Phase III program - Progress derivatives towards
clinic - Secure partner EN101 Myasthenia - Phase IIa - Conclude
Phase Gravis IIa - Conduct further Phase II Sublingual Parkinson's
- Phase I - Complete final apomorphine disease Phase I study -
Commence Phase II study Other Programs AMR101 AAMI - Phase IIa -
Complete Phase (ultra-pure trial underway IIa trial ethyl-EPA)
Nasal lorazepam Epilepsy - Preclinical - File IND proof of concept
- Commence Phase successful I - Planning for Phase I AMR103
(targeted Parkinson's - Preclinical - Complete final lipid
transport disease proof of preclinical of levodopa) concept studies
studies completed - File IND successfully Platform Various -
Preclinical - Advance technologies preclinical development work
-Targeted Lipid and platform Transport (TLT) validation
-Cholinergic modulation/ inflammation Further details about
Amarin's development programs are available on the Company's
website at http://www.amarincorp.com/ Partnering The Company's
combined neuroscience and cardiovascular pipelines offer a number
of opportunities to partner for markets outside the US or for
primary care markets globally. The Company's current business
development activities are focused on three key projects: 1) US
partnering for Miraxion (AMR101) in HD; 2) US/global partnering for
cardiovascular program; and 3) European partnering for neuroscience
programs. Management Team In recent quarters Amarin has expanded
its management team, particularly in the research and development
function, to ensure it can progress multiple development programs
simultaneously. Amarin now has a highly experienced and committed
management team. All of Amarin's key members of management have
worked the vast majority, if not all, of their careers in the
pharmaceutical and biotechnology industry in companies such as
Pfizer, Novartis, GlaxoSmithKline (GSK), Elan, Cardinal Health and
Cephalon. Management Position Previous Experience Thomas Lynch
Chairman and Chief Executive Vice Executive Officer Chairman, Chief
Financial Officer, Elan Warner Chilcott, ICON 25 years experience
Alan Cooke President, Chief VP, Global Strategic Operating Officer
Planning, Elan 16 years experience Dr. Declan Head of Research and
SVP and Head of Doogan Development Worldwide Development, Pfizer
Global Research and Development 30 years experience Paul Duffy
President, US Commercial Novartis, Alamo Operations 30 years
experience Dr. Keith Wood Head of Research and Pfizer, Roche,
Janssen Development Operations 30 years experience Dr. Tony Clarke
VP, Clinical Development Cephalon, RP Scherer, GSK 25 years
experience Dr. Mehar Manku VP, Research Laxdale, Scotia Research
Institute 25 years experience Tom Maher VP, General Counsel
Matheson Ormsby Prentice, Elan, A&L Goodbody 20 years
experience Darren EVP, Strategic Elan, Glen Dimplex, PWC Cunningham
Development and Investor 14 years experience Relations Stuart
Sedlack EVP, Corporate Novartis, Elan, ABN Development AMRO 20
years experience Facilities Amarin is in the process of closing its
London office and now operates primarily from two locations. The
Company's research and development facility is located in Oxford,
England, and its corporate group in Dublin, Ireland. Amarin also
has a presence in the United States through corporate development
and commercial staff located on the East Coast. Corporate Strategy
Amarin intends to directly commercialize its neuroscience products
in the United States via its own commercial infrastructure and to
out-license or partner its neuroscience product rights outside the
United States. Amarin also intends to out-license or partner its
pipeline globally for broader indications such as cardiovascular
disease. Reverse Split The reverse split, comprising the
consolidation of every 10 existing Ordinary Shares into one
Ordinary Share, took place at 5.00pm GMT, January 17, 2008. The
consolidated Ordinary Shares were admitted to trading on AIM and
IEX at 8.00 am GMT, January 18, 2008, under the new ISIN
GB00B29VL935. Following the reverse split, there are now 14,003,237
Ordinary Shares in issue. Each American Depositary Share ("ADS")
continues to represent one Ordinary Share following the reverse
split. Accordingly, the 1 for 10 reverse split of Ordinary Shares
has a corresponding effect on all outstanding ADSs and the
corresponding effective date for ADSs is January 18, 2008. 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 the recently acquired
myasthenia gravis clinical program and preclinical programs in
neuromuscular, neuronal degenerative and inflammatory diseases;
Miraxion for Huntington's disease; two programs in Parkinson's
disease; one in epilepsy; and one in memory. 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 two proprietary
technology platforms, a lipid-based technology platform for the
targeted transport of molecules through the liver and/or to the
brain, and a unique mRNA technology based on cholinergic
neuromodulation. Amarin has its primary stock market listing in the
U.S. on the NASDAQ Capital Market ("AMRN") and secondary listings
in the U.K. and Ireland on AIM ("AMRN") and IEX ("H2E"),
respectively. In accordance with customary Nasdaq practice, with
effect from January 18, 2008, and for a period of 20 trading days,
a "D" will be appended to Amarin's Nasdaq ticker symbol and during
that period Amarin's Nasdaq ticker symbol will appear as "AMRND".
Disclosure Notice The information contained in this document is as
of January 18, 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: risks relating to
the Company's ability to maintain its Nasdaq listing (including the
risk that the Company may not successfully appeal a Nasdaq
delisting determination); 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, including its planned clinical trials in
cardiovascular disease and; 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; general changes in
International and US generally accepted accounting principles; 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, 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, Amarin's Report of Foreign Issuer
(Updated and Additional Risk Factors) furnished on a Form 6-K to
the SEC on January 8, 2008 and in Amarin's other Reports of Foreign
Issuer on Form 6-K furnished to the SEC. DATASOURCE: Amarin
Corporation Plc CONTACT: Contacts: Amarin: Thomas Lynch, Chairman
and Chief Executive Officer, +44(0)1865-784-210, Alan Cooke,
President and Chief Operating Officer, +353(1)669-9020, ;
Investors: Lippert/Heilshorn & Associates, Inc., Anne Marie
Fields +1-212-838-3777, Bruce Voss +1-310-691-7100; Media:
Powerscourt +44(0)207-250-1446, Rory Godson, Paul Durman, Sarah
Daly
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