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".
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
Miraxion Huntington's - Two Phase - Publish
disease III trials 12-month Phase
(AMR101 / completed III data
ethyl-EPA) - One - Secure US
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
FDA on design of
- Secure partner
EN101 Myasthenia - Phase IIa - Conclude Phase
further Phase II
Sublingual Parkinson's - Phase I - Complete final
apomorphine disease Phase I study
- Commence Phase
AMR101 AAMI - Phase IIa - Complete Phase
(ultra-pure trial underway IIa trial
Nasal lorazepam Epilepsy - Preclinical - File IND
concept - Commence Phase
- Planning for
AMR103 (targeted Parkinson's - Preclinical - Complete final
lipid transport disease proof of preclinical
of levodopa) concept studies
completed - File IND
Platform Various - Preclinical - Advance
-Targeted Lipid and platform
Transport (TLT) validation
Further details about Amarin's development programs are available on the Company's website at http://www.amarincorp.com
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.
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
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
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,
25 years experience
Dr. Mehar Manku VP, Research Laxdale, Scotia
25 years experience
Tom Maher VP, General Counsel Matheson Ormsby
Prentice, Elan, A&L
20 years experience
Darren EVP, Strategic Elan, Glen Dimplex, PWC
Cunningham Development and Investor 14 years experience
Stuart Sedlack EVP, Corporate Novartis, Elan, ABN
20 years experience
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.
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.
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.
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".
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.
|SOURCE Amarin Corporation Plc|
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