UNITED STATES
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 August, 2010.
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 ¨
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 ¨ 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 ¨ 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 ¨ No x
If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-______________.
This report on Form 6-K is hereby incorporated by reference into the registration statements of Amarin Corporation plc and in the prospectus contained therein, and this report on Form 6-K shall be deemed a part of each such registration statement from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished by Amarin Corporation plc under the Securities Act of 1933 or the Securities Exchange Act of 1934.
AMARIN CORPORATION PLC
On August 10, 2010, Amarin Corporation plc (“the Company”) announced that its MARINE trial, a Phase 3 clinical trial of AMR101, has completed patient enrollment and randomization into the treatment phase of this trial. The primary endpoint in the MARINE trial is the percentage change in triglyceride level from baseline after 12 weeks of treatment. Consistent with the protocol for this trial, the Company expects that the 229 patients randomized in this study will be sufficient to achieve statistical significance. The Company indicated that top line results from this trial are expected early in 2011, towards the early part of the range of guidance provided previously.
The Company also announced that, as of August 10, 2010, over half of the 650 patients currently targeted for the ANCHOR trial, a separate on-going Phase 3 trial for AMR101, have been enrolled and randomized to dosing. This trial is designed to evaluate the safety and efficacy of AMR101 in patients with high triglyceride levels who are also on statin therapy for elevated LDL cholesterol levels. The Company anticipates completing patient enrollment and randomization for ANCHOR in 2011 and reporting top-line results from the ANCHOR trial in 2011.
Important Note:
This filing contains forward-looking statements, including statements about the timing of clinical trial results and the potential indications and market opportunity for AMR101 if approved by the U.S. Food and Drug Administration. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein are the following: anticipated operating losses and the likely need for additional capital to fund future operations; uncertainties associated generally with research and development, clinical trials and related regulatory approvals; the risk that historical enrollment and randomization rates may not be predictive of future results; dependence on third-party manufacturers, suppliers and collaborators; significant competition; loss of key personnel; and uncertainties associated with market acceptance and adequacy of reimbursement, technological change and government regulation. A further list and description of these risks, uncertainties and other matters can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 20-F. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this filing, whether as a result of new information, future events or circumstances or otherwise.
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/ John Thero
John Thero
Chief Financial Officer
Date: August 11, 2010