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): January 27, 2012
ALKERMES PLC
(Exact name of registrant as specified in its charter)
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Ireland |
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001-35299 |
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98-1007018 |
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(State or other jurisdiction |
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(Commission |
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(IRS Employer |
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of incorporation) |
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File Number) |
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Identification No.) |
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Treasury Building, Lower Grand Canal Street |
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Dublin 2, Ireland |
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(Address of principal executive offices) |
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(Zip Code) |
(Registrant’s telephone number, including area code): +353-1-709-4000
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 (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 7.01 Regulation FD Disclosure
On January 27, 2012, Amylin Pharmaceuticals, Inc. (“Amylin”) and Alkermes plc (“Alkermes”) announced that the U.S. Food and Drug Administration (“FDA”) has approved BYDUREON™ (exenatide extended-release for injectable suspension) — the first once-weekly treatment for type 2 diabetes. A copy of the press release is attached hereto as Exhibit 99.1. This information, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or incorporated by reference in any filing under the Securities Act or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits.
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Exhibit |
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No. |
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Description |
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99.1 |
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Press release issued by Amylin and Alkermes dated January 27, 2012, announcing the approval of BYDUREON by the FDA. |
SIGNATURE
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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ALKERMES PLC | |
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Date: January 27, 2012 |
By: |
/s/ James M. Frates |
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James M. Frates |
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Senior Vice President and Chief Financial Officer |
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(Principal Financial and Accounting Officer) |