-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, EZAsHkp18sDSbRnysIRze/6oVui/RcBcNfZM1IW4kJue3ZrX7YjKlz26Y75bOT4t 5K7GUW76iDyw4Dr7fcVACg== 0000897448-09-000006.txt : 20090408 0000897448-09-000006.hdr.sgml : 20090408 20090408104616 ACCESSION NUMBER: 0000897448-09-000006 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090408 FILED AS OF DATE: 20090408 DATE AS OF CHANGE: 20090408 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AMARIN CORP PLC\UK CENTRAL INDEX KEY: 0000897448 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 0831 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21392 FILM NUMBER: 09739008 BUSINESS ADDRESS: STREET 1: FIRST FLOOR, BLOCK 3, THE OVAL, STREET 2: SHELBOURNE ROAD, BALLSBRIDGE CITY: DUBLIN STATE: L2 ZIP: 00000 BUSINESS PHONE: 353 1 6699 020 MAIL ADDRESS: STREET 1: FIRST FLOOR, BLOCK 3, THE OVAL, STREET 2: SHELBOURNE ROAD, BALLSBRIDGE CITY: DUBLIN STATE: L2 ZIP: 00000 FORMER COMPANY: FORMER CONFORMED NAME: AMARIN PHARMACEUTICALS PLC DATE OF NAME CHANGE: 20000201 FORMER COMPANY: FORMER CONFORMED NAME: ETHICAL HOLDINGS PLC DATE OF NAME CHANGE: 19930322 6-K 1 amarin6kpressrelease_080409.htm AMARIN CORP. PRESS RELEASE amarin6kpressrelease_080409.htm
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549
 
FORM 6-K
 
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
under the Securities Exchange Act of 1934
 
For the month of April, 2009.
 
Commission File Number 0-21392
 
                                   AMARIN CORPORATION PLC
(Translation of registrant's name into English)
 
                       First Floor, Block 3, The Oval, Shelbourne Road, Ballsbridge, Dublin 4, Ireland
(Address of principal executive offices)
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
 
Form 20-F x
 
Form 40-F  o
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
 
Yes  o
 
No  x
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
 
Yes  o
 
No  x
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrant's "home country"), or under the rules of the home country exchange on which the registrant's securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrant's security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
 
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
 
Yes  o
 
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If "Yes" is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):

EXHIBIT LIST
 
Exhibit
Description
   
99.1
Press release dated April 8, 2009 titled:
 
Amarin's Marketing Authorization Application for AMR101 to treat Huntington's Disease accepted for review by EMEA.

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

AMARIN CORPORATION PLC
 
By: /s/ Tom Maher
Tom Maher
General Counsel
Date: April 8, 2009


EX-99.1 CHARTER 2 ex99_1.htm EXHIBIT 99.1 ex99_1.htm

AMARIN’S MARKETING AUTHORIZATION APPLICATION FOR AMR101 TO TREAT HUNTINGTON’S DISEASE ACCEPTED FOR REVIEW BY EMEA

DUBLIN, Ireland, April 8, 2009 – Amarin Corporation plc (NASDAQ: AMRN) today announced that the European Medicines Agency (EMEA) has accepted for review the Company's Marketing Authorization Application (MAA) for AMR101 (ultra-pure ethyl-EPA) in patients with Huntington’s disease.

Thomas Lynch, Chairman and Chief Executive Officer of Amarin, commented “We are pleased to have our EMEA filing for AMR101 in Huntington’s disease accepted for review as it is a disorder of great unmet medical need. Given the excellent safety and tolerability profile of AMR101, and the significant impact it demonstrated in a Phase 3 trial on slowing the disease progression over 12 months, it could offer patients a much needed advance in treatment.”

Mr. Lynch added “While we are now focusing our resources and development activities on our cardiovascular disease programs, pursuing marketing approval for AMR101 to treat Huntington’s disease in Europe remains a potentially valuable opportunity for the Company.”

The application is based on clinical data which includes results from the Company’s multi-centre, double-blind, placebo-controlled Phase 3 study of AMR101 in 316 patients with Huntington’s disease conducted in the U.S. and Canada (TREND-HD). Amarin announced in 2007 the results of its Phase 3 studies conducted in U.S, Canada and Europe in which AMR101 did not show a statistically significant effect at six months, but did however show a significant treatment effect at twelve months, in the 192 patients who completed a six month open label extension to the TREND-HD study. These results were consistent with the positive effect of AMR101 over longer treatment periods of 12 and 24 months in earlier studies conducted by Amarin.

The filing also included data from a recently published magnetic resonance imaging (MRI) study investigating the comparative effects of AMR101 and placebo on the cerebral pathology of patients with Huntington’s disease. The data show a reduced rate of cerebral atrophy in patients receiving AMR101, with the most significant impact in those areas implicated in the aetiology of Huntington’s disease, including the head of the caudate nucleus.

While no further studies have been conducted since the results of the Phase 3 studies were announced in 2007, the filing did include additional detailed analysis of the data from these Phase 3 studies which further supports the benefit of AMR101 in Huntington’s disease over longer treatment periods.

AMR101 has been designated as an Orphan Medicinal Product in the European Union for the treatment of Huntington’s disease, which, if approved, entitles the drug to ten years of market exclusivity for the approved indication. Amarin has also secured patents for the use of AMR101 to treat Huntington’s disease, with expiry dates ranging from 2020 to 2023.

About Huntington’s Disease
Huntington’s disease ("HD") is a genetic neurodegenerative disease characterized by movement disorder, dementia and psychiatric disturbance. HD has been diagnosed in approximately 40,000 people in Europe. Additionally, over 200,000 persons in Europe are genetically “at risk” to developing the disease. HD is believed to be caused by a genetic mutation of cytosine, adenosine and guanine (CAG) polymorphic trinucleotide repeat located on chromosome 4p16.3. It is believed that there is a direct link between CAG repeat length and age of onset, disease progression and clinical symptoms of HD disease. Onset of symptoms is typically between 30-50 years of age with a typical life expectancy from diagnosis of 10-25 years depending on the CAG repeat length. Patients with late stage disease require continuous nursing care.

About Amarin
Amarin is a late clinical-stage biopharmaceutical company with a lead program planned to enter Phase 3 for hypertriglyceridemia. Amarin’s cardiovascular programs capitalize on its expertise in the field of lipid science and the known therapeutic benefits of essential fatty acids in cardiovascular disease. Amarin’s pipeline also includes programs in myasthenia gravis, Huntington’s disease, Parkinson’s disease and epilepsy, all of which are available for partnering. Amarin is listed in the U.S. on the NASDAQ Capital Market (“AMRN”). For more information please visit www.amarincorp.com.

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

Disclosure Notice
This document contains forward looking statements about AMR101 for Huntington’s disease 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: decisions by regulatory authorities, including the European Medicines Agency, regarding whether and when to approve Amarin’s Marketing Authorization Application for AMR101 in patients with Huntington’s disease, as well as its decisions regarding labeling and other matters that could affect the commercial potential of AMR101; the speed with which regulatory  authorization, pricing approval and product launch maybe achieved with respect to AMR101; whether and when Amarin will be able to enter into and consummate a strategic collaboration with respect to AMR101 for Huntington’s disease on acceptable terms; the success with which any developed product may be commercialized; competitive developments affecting AMR101, including generic and branded competition; 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, the trend towards managed care and health care cost containment; Amarin's ability to protect its patents and other intellectual property; claims and concerns that may arise regarding the safety or efficacy of AMR101; and Amarin’s ability to maintain sufficient cash and other liquid resources to meet its liquidity needs. 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, 2007, filed with the SEC on May 19, 2008 and Amarin’s Form 20-F/A for the fiscal year ended December 31, 2007 filed with the SEC on September 24, 2008. Amarin assumes no obligation to update any forward-looking statements as a result of new information, future events or otherwise.



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