In the News
Amarin Proceeding to Phase 3 with AMR101 for Hypertriglyceridemia
FDA Meeting to Discuss Development Plan Completed Successfully
DUBLIN, Ireland, July 22, 2008 – Amarin Corporation plc (NASDAQ: AMRN) today 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”).
Contacts:
Amarin +353 (0)1 669 9020
Thomas Lynch, Chairman and Chief Executive Officer
Alan Cooke, President and Chief Operating Officer
Darren Cunningham, EVP Strategic Development and Investor Relations
investor.relations@amarincorp.com
Amarin announces private placement for up to $60 million
DUBLIN, Ireland, May 14, 2008 – Amarin Corporation plc (NASDAQ: AMRN) today announced a private placement of American Depositary Shares (each representing one ordinary share) (“ADSs”) with several new institutional and accredited investors, and potentially certain directors of the Company, for up to $60 million funded over two equal tranches.
The new investors, who have entered into definitive agreements for gross proceeds of up to $56 million, comprise Sofinnova Ventures, OrbiMed Advisors LLC, Thomas, McNerney & Partners, Panorama Capital, Longitude Capital and Fountain Healthcare Partners. The first $28 million tranche is expected to close shortly, subject to customary closing conditions. The investors will have an option to provide up to $28 million in a second tranche upon completion of certain business milestones by the Company, potentially over the next 12 months.
Certain directors of Amarin have indicated an interest in investing up to an additional $4 million in the placement, also over two equal tranches, bringing the potential total of the placement up to $60 million. Cowen and Company LLC acted as the lead placement agent for the transaction.
Thomas Lynch, Chairman and Chief Executive Officer of Amarin, commented “This financing strengthens our balance sheet considerably, and allows us to accelerate our key clinical development programs. We are now well positioned to take advantage of the significant opportunities available to the Company.”
Alan Cooke, President and Chief Operating Officer of Amarin, added “We are delighted with the participation by well recognised biotech investors and by the continued support of our directors, which we believe reflects the attractive investment proposition Amarin represents.”
The Company intends to use the proceeds from this financing for progressing its cardiovascular and CNS research and development pipeline, for general corporate purposes, and the retirement of its $2.75 million convertible debentures issued in December 2007, after which the company will be debt free.
The first tranche of $28 million will be settled by the issuance of 12,173,914 new Ordinary Shares and the potential $2 million investment by directors would be settled by 869,565 new Ordinary Shares, all at $2.30 per share. The second tranche would be settled by the issuance of ADSs at a price equal to the lower of (i) $2.60, and (ii) 113% of the average of the volume weighted average prices of Amarin’s ADSs as reported on NASDAQ for each of the 30 trading days immediately prior to the date of the closing of the second tranche.
Following closing of the first tranche, the new investors will hold approximately 45% of the Ordinary Shares of the Company. Certain of the new investors will be entitled to join Amarin’s Board and will obtain various rights relating to the appointment of directors and pre-emption on further issues of shares by Amarin.
City Code and Regulatory Disclosures
Following the recent move of the place of central management of the Company to Ireland, the City Code on Takeovers and Mergers (the "Code") does not apply to Amarin, as the Company does not fall within paragraph 3(a)(ii) of the Introduction to the Code.
The securities offered in the private placement are not registered under the Securities Act of 1933, as amended (the "Act"), or any state securities laws, and may not be offered or sold in the United States absent registration, or an applicable exemption from registration, under the Act and applicable state securities laws.
Under an agreement with the investors, the Company is required to file a registration statement with the United States Securities and Exchange Commission covering the resale of the shares of common stock to be issued to the investors no later than sixty days after each closing and to use reasonable best efforts to have the registration statement declared effective as soon as practicable thereafter. Application has been made to list 12,173,914 ordinary shares on AIM and IEX respectively.
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities. There shall not be any sale of these securities in any jurisdiction in which such offering would be unlawful.
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 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 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”).
Contacts:
Amarin +353 (0)1 669 9020
Thomas Lynch, Chairman and Chief Executive Officer
Alan Cooke, President and Chief Operating Officer
Darren Cunningham, EVP Strategic Development and Investor Relations
Investor Relation
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
Disclosure Notice
The information contained in this document is as of May 14, 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; 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; general changes in International 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.
Launch of Fountain Healthcare Partners, a Life Science Venture Capital Firm
Launch of Fountain Healthcare Partners, a Life Science Venture Capital Firm
-- announces First Close of €75 ($117) million --
-- largest life science venture capital ("VC") fund launched in Ireland --
-- one of the largest emerging manager VC funds raised in the life science sector globally --
-- headquartered in Dublin, Fountain will invest the majority of its capital in Europe with a primary focus on Ireland --
Dublin, Ireland., and New York April 29th 2008 - Fountain Healthcare Partners ("Fountain") today launches and announces the first close of its inaugural fund, Fountain Healthcare Partners I, with €75 ($117) million of committed capital.
The fund is the largest dedicated life science (specialty pharmaceuticals, biotechnology, medical devices and diagnostics) venture capital ("VC") firm based in Ireland. It is also one of the largest emerging manager VC funds raised in the life science sector globally in the past 2 years.
Fountain will invest the majority of its capital in Europe and will have a strong emphasis on the life science sector in Ireland. The first close significantly exceeded initial expectations and Fountain is now targeting approximately €100 million in commitments at its final close.
Over 90% of the capital invested in the fund was sourced from institutional investors of which 75% are Irish based. Institutional investors include the European Investment Fund, the National Pension Reserve Fund and Enterprise Ireland. A select number of high net worth individual investors also participated. "We have been very pleased with the level and quality of investor participation in the first close. There was clear support for our investment strategy, and we significantly exceeded our original first close target," said Dr Manus Rogan, a founding partner at Fountain.
Fountain is a bi-located fund with a main office in Dublin and a second office in New York. "The purpose of our New York office is to maintain on-the-ground connectivity with the US life-science sector. Specifically this office will provide our firm and our investee companies access to people, intellectual property, partnering and exit opportunities, syndication capital and deal flow," said Aidan King, Fountain's New York based partner.
Speaking at the launch of the fund, Minister for Enterprise, Trade and Employment, Micheál Martin T.D, said " A dynamic and healthy venture capital market is a prerequisite for the growth and development of high potential start-up companies in Ireland. I am delighted to announce the establishment of Fountain Healthcare Partners I, the fourth fund to be established under the Enterprise Ireland Seed and Venture Capital Scheme 2007-2012."
"The life science, healthcare and pharmaceutical sectors are key sectors in the Irish economy employing over 40,000 people in Ireland. The Fountain Fund is therefore very significant given its size and its focus on the life sciences sector" he added.
Fountain is a product-focused VC fund and will invest in companies with product development programmes that have a defined pathway to commercialisation, value enhancement and exit. The principals will take an active role with investees and will bring considerable industry expertise and a deep network of contacts in the US, Europe and Asia to investee companies.
The Fund will invest €0.5m to €7.0 million per company and will have an emphasis on the following sub-sectors: specialty pharmaceuticals, biotechnology, medical devices and diagnostics. Fountain will invest this capital over multiple funding rounds alongside international and domestic life science focused VC firms.
Fountain's investment premise holds that the global lifescience sector dynamics are currently very favourable for smaller venture backed private companies. Fountain also maintains that the Irish life science industry is at a turning point and has been underserved from a VC perspective.
- Ireland is Europe's most established location for global life science companies with over 40,000 people employed in the sector generating exports of over €27 billion. Thirteen of the top 15 pharmaceutical companies and 15 of the largest 25 medical device companies in the world have substantial operations in Ireland.
- The Irish government, over the period from 2000 to 2008, will have invested over €8 billion to accelerate the development of an indigenous science and technology base. A further €8.2 billion will be invested between 2006 and 2013.
- In the past five years a significant number of life science companies have been formed in Ireland and many are actively seeking capital to advance product development.
- Venture investing in the life science sector in Ireland has lagged behind other life science clusters in the US or Europe. Fountain is being established to fill this gap and capitalise on this opportunity.
Contact Information:
Ireland:
Aisling Garvey
FD – Dublin
Tel: + 353 1663 3607
+ 353 8741 69662
UK & Europe:
Deborah Scott/John Dineen
FD- London
Tel: + 44 (0)20 7269 7193
About Fountain Healthcare Partners
Headquartered in Dublin, Fountain Healthcare Partners is Ireland's largest dedicated life science venture capital fund. A spin-out investment team from Elan Corporation's corporate venture capital group, Fountain launched its inaugural fund in 2008. Fountain will invest the majority of its capital in Europe with a primary focus on Ireland. Specific areas of interest to Fountain are specialty pharmaceuticals, biotechnology, medical devices and diagnostics. For more information please visit www.fh-partners.com.
The principals in Fountain are Dr Manus Rogan (Elan Corporation, GlaxoSmithKline), Aidan King (Bio-IB, Elan Corporation), Dr Ena Prosser (Enterprise Ireland, Elan Corporation) and Justin Lynch (LegendCare, Fyffes, Jones Group and NCB). The core team is also supported by world class Business and Scientific Advisory Boards.
Fountain's core team have over 60 years of venture investment and operational experience in the life sciences industry, making the firm the most experienced life science VC firm based in Ireland. As former members of Elan Corporation's (NYSE:ELN) corporate VC group, Fountain's principals have invested in 25 life science companies prior to setting up Fountain. These include Acusphere (IPO on NASDAQ, ACUS), Allergy Therapeutics (IPO on AIM, AGY:LN), Idun Therapeutics (acquired by Pfizer), Atrix Laboratories (acquired by QLT Inc.) and Sirna Therapeutics (acquired by Merck & Co.).
The EIF's investment in Fountain is though the European Union's Competitiveness and Innovation Framework Programme ("CIP")