0000950103-11-001947.txt : 20110520 0000950103-11-001947.hdr.sgml : 20110520 20110520123611 ACCESSION NUMBER: 0000950103-11-001947 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20110519 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110520 DATE AS OF CHANGE: 20110520 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Shire plc CENTRAL INDEX KEY: 0000936402 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-29630 FILM NUMBER: 11860590 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 ZIP: R924 8EP BUSINESS PHONE: 441256894000 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 ZIP: R924 8EP FORMER COMPANY: FORMER CONFORMED NAME: Shire Ltd. DATE OF NAME CHANGE: 20080523 FORMER COMPANY: FORMER CONFORMED NAME: Shire plc DATE OF NAME CHANGE: 20051125 FORMER COMPANY: FORMER CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP PLC DATE OF NAME CHANGE: 19980302 8-K 1 dp22662_8k.htm FORM 8-K
 
 
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): May 19, 2011

Shire plc
________________________________________________________________________________
(Exact name of registrant as specified in its charter)

Jersey, Channel Islands
________________________________________________________________________________
(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
________________________________________________________________________________
(Address of principal executive offices)                              (Zip code)

Registrant's telephone number, including area code             +353 1 429 7700


________________________________________________________________________________
(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.f13e-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 May 19, 2011
 
 
 

 

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.


 
SHIRE PLC
 
     
     
 
By:
/s/ A C Russell  
    Name:
Angus Russell
 
    Title:
Chief Executive Officer
 


 
Dated: May 19, 2011
 
 
 

 
 
EXHIBIT INDEX
 
Number   
Description
 
 99.01
Press Release dated May 19, 2011
 
 
 

 
 
EX-99.1 2 dp22662_ex9901.htm EXHIBIT 99.1
 
Exhibit 99.01
 
Press Release
www.shire.com
 
   

Shire Receives VYVANSE® Paragraph IV Notice Letter

Dublin, Ireland – May 19, 2011 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has received a Paragraph IV Notice Letter from Sandoz Inc. (“Sandoz”) advising of the filing of an Abbreviated New Drug Application (“ANDA”) for a generic version of all strengths of lisdexamfetamine dimesylate capsules, VYVANSE.  This is the first Paragraph IV Notice Letter directed to VYVANSE received by the company.

VYVANSE is protected by sixteen FDA Orange Book listed patents, all of which expire in 2023.

Shire is currently reviewing the details of Sandoz’s Paragraph IV Notice Letter, which was directed to all of the patents listed in the Orange Book.

Under the Hatch-Waxman Act, Shire has 45 days from the receipt of the Notice Letter to determine if it will file a patent infringement suit.  If Shire brings suit pursuant to the Hatch-Waxman regulations, a 30-month stay of approval will be imposed by the FDA on Sandoz’s ANDA.

The Hatch-Waxman exclusivity period for VYVANSE runs until February 23, 2012.


 
For further information please contact:

Investor Relations
Eric Rojas (erojas@shire.com)
+1 781 482 0999
 
Sarah Elton-Farr (seltonfarr@shire.com)
+44 1256 894157
Media
Jessica Mann (jmann@shire.com)
+44 1256 894 280
 
Matthew Cabrey (mcabrey@shire.com)
+1 484 595 8248

 
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 (ADHD), human genetic therapies (HGT) and gastrointestinal (GI) diseases 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.
 
 
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
 
 

 

"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 Pharmaceutical and Human Genetic Therapies products, as well as the ability to secure and integrate 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.
 
 
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
 

 
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