Current Report Filing (8-k)
August 07 2015 - 4:42PM
Edgar (US Regulatory)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported): August 7, 2015
Amarin Corporation plc
(Exact name of registrant as specified in its charter)
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| England and Wales |
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0-21392 |
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Not applicable |
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of incorporation) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
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| 2 Pembroke House, Upper Pembroke Street 28-32, Dublin 2, Ireland |
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Not applicable |
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(Zip Code) |
Registrant’s telephone number, including area code: +353 1 6699 020
Not Applicable
Former
name or former address, if changed since last report
Check the appropriate box below
if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On August 7, 2015, Amarin Corporation plc (“Amarin”) announced that the
federal district court for the southern district of New York granted Amarin’s request for a declaratory judgment in Amarin’s lawsuit against the United States Food and Drug Administration (“FDA”) seeking Amarin’s ability to
promote to healthcare professionals certain uses of Amarin’s lead product, Vascepa®(icosapent ethyl) capsules, that are not covered by current FDA-approved labeling for the drug so long
as the promotion is truthful and non-misleading. The court declaration covers promotion of the FDA-reviewed and agreed effects of Vascepa demonstrated in Amarin’s ANCHOR clinical trial of patients with persistently high triglycerides after
statin therapy and use of peer-reviewed scientific publications that present the current state of scientific research related to the potential of Vascepa to reduce the risk of cardiovascular disease. An appeal of the court’s decision can be
filed within 60 days.
Forward-looking statements
This Current Report on Form 8-K contains forward-looking statements, including statements about any appeal of this decision by FDA. 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 include the following: the risk that FDA may
appeal the order, and the result of any such appeal, and uncertainties associated generally with litigation, research and development, clinical trials and related regulatory approvals. A further list and description of these risks, uncertainties and
other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q. Existing and
prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this Form 8-K, 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
hereunto duly authorized.
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| Date: August 7, 2015 |
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Amarin Corporation plc |
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By: |
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/s/ John Thero |
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John Thero |
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President and Chief Executive Officer |
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