Statement re business update
January 18 2008 - 8:26AM
UK Regulatory
RNS Number:0992M
Amarin Corporation Plc
18 January 2008
AMARIN PROVIDES BUSINESS UPDATE AND ANNOUNCES IMPLEMENTATION OF REVERSE STOCK
SPLIT
LONDON, United Kingdom, January 18, 2008 - 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 III - Publish 12-month
(AMR101 / disease trials completed Phase III data
ultra-pure - One additional - Secure US partner
ethyl-EPA) Phase III trial - Commence final Phase
required III trial with a partner
AMR101 Cardiovascular - Clinical - Progress ongoing
(ultra-pure program with AMR101 clinical program
ethyl-EPA) and commenced late 2007 - Obtain guidance from
derivatives FDA on design of
triglyceride Phase III
program
- Progress derivatives
towards clinic
- Secure partner
EN101 Myasthenia - Phase IIa - Conclude Phase IIa
Gravis - Conduct further Phase II
Sublingual Parkinson's - Phase I - Complete final Phase
apomorphine disease I study
- Commence Phase II study
Other Programs
AMR101 AAMI - Phase IIa - Complete Phase IIa trial
(ultra-pure trial underway
ethyl-EPA)
Nasal lorazepam Epilepsy - Preclinical proof - File IND
of concept - Commence Phase 1
successful
- Planning for Phase I
AMR103 Parkinson's - Preclinical proof - Complete final
(targeted lipid disease of concept studies preclinical studies
levodopa) completed - File IND
successfully
Platform Various - Preclinical - Advance preclinical
technologies development work and
-Targeted Lipid platform validation
Transport (TLT)
-Cholinergic
modulation/
inflammation
Further details about Amarin's development programs are available on the
Company's website at 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 Chairman and Chief Executive Vice Chairman, Chief Financial
Lynch Executive Officer Officer, Elan
Warner Chilcott, ICON
25 years experience
Alan Cooke President, Chief Operating VP, Global Strategic Planning, Elan
Officer 16 years experience
Dr. Declan Head of Research and SVP and Head of Worldwide Development,
Doogan Development Pfizer Global Research and Development
30 years experience
Paul Duffy President, US Commercial Novartis, Alamo
Operations 30 years experience
Dr. Keith Head of Research and Pfizer, Roche, Janssen
Wood Development Operations 30 years experience
Dr. Tony VP, Clinical Development Cephalon, RP Scherer, GSK
Clarke 25 years experience
Dr. Mehar VP, Research Laxdale, Scotia Research Institute
Manku 25 years experience
Tom Maher VP, General Counsel Matheson Ormsby Prentice, Elan, A&L
Goodbody
20 years experience
Darren EVP, Strategic Development Elan, Glen Dimplex, PWC
Cunningham and Investor Relations 14 years experience
Stuart EVP, Corporate Development Novartis, Elan, ABN AMRO
Sedlack 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, w
ith 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".
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
investor.relations@amarincorp.com
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
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.
# # #
This information is provided by RNS
The company news service from the London Stock Exchange
END
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