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): June 23, 2012
Shire plc
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(Exact name of registrant as specified in its charter)
Jersey, Channel Islands
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(State or other jurisdiction of incorporation)
0-29630 98-0601486
(Commission File Number) (IRS Employer Identification No.)
5 Riverwalk, Citywest Business Campus, Dublin
24, Republic of Ireland
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(Address of principal executive offices) (Zip code)
Registrant's telephone number, including area code +353 1 429 7700
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(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 (see General Instruction A.2.):
[ ] Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01. Other Events
Shire plc has issued the press release attached hereto as Exhibit 99.01 which is incorporated by reference herein.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits. The following exhibit is filed herewith:
99.01 Press Release dated June 23, 2012
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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SHIRE PLC
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By:
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/s/ A C Russell | ||
| Name: Angus Russell | |||
| Title: Chief Executive Officer | |||
Dated: June 25, 2012
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EXHIBIT INDEX
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Number
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Description
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99.01
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Press release dated June 23, 2012
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Exhibit 99.01
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Press Release
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www.shire.com
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Shire Announces that the US Food and Drug Administration has Responded to Its Citizen Petition for Adderall XR and has Approved One Abbreviated New Drug Application for Generic Adderall XR
Shire continues to expect to deliver good full year 2012 earnings growth
Philadelphia US – June 23, 2012 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that on June 22, 2012, the US Food and Drug Administration (FDA) responded to Shire’s Adderall XR citizen petition. The FDA’s response requires that all abbreviated new drug applications ( ANDAs) have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA response is consistent with its recent decisions on other long acting ADHD products.
The FDA also informed Shire on June 22, 2012 that it has approved the ANDA for generic Adderall XR filed by Actavis. The FDA has not approved any other Adderall XR ANDAs.
Shire believes that it will remain competitive in the Adderall XR marketplace through the distribution of branded Adderall XR and through its two authorized generic partners, Teva and Impax. While recognizing that there will be multiple dynamics affecting the overall market following the approval of the Actavis generic, Shire continues to believe that it will deliver good, full year 2012 earnings growth.
For further information please contact:
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Investor Relations
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Eric Rojas
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erojas@shire.com
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+1 781 482 0999
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Sarah Elton-Farr
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seltonfarr@shire.com
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+44 1256 894157
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Media
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Jessica Mann (Corporate)
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jmann@shire.com
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+44 1256 894 280
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Gwen Fisher (Specialty Pharma)
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gfisher@shire.com
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+1 484 595 9836
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Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
Notes to editors
SHIRE PLC
Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.
For further information on Shire, please visit the Company’s website: www.shire.com.
"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company’s Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company’s products; the Company’s ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company’s products; the Company’s ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company’s ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company’s filings with the Securities and Exchange Commission.