-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, D+LnOZkKnv4FjhiP6XL+RlV6glDry/J85PfTi8rJ/pStdlM8wbH4wo9j+1Jq/u4E qKTdPmP3hhOosy4ICWKbNA== 0000950103-11-000735.txt : 20110224 0000950103-11-000735.hdr.sgml : 20110224 20110224135417 ACCESSION NUMBER: 0000950103-11-000735 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20110224 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20110224 DATE AS OF CHANGE: 20110224 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: 11635362 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 dp21359_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): February 24, 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 February 24, 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: February 24, 2011
 
 
 

 
 
EXHIBIT INDEX
 
Number
Description
 
99.01
Press Release dated February 24, 2011
 
 


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Exhibit 99.1
 
 
Press Release
www.shire.com
 

Shire Receives new Paragraph IV Notice Letter From Watson for ADDERALL XR®

Dublin, Ireland and Philadelphia, US – February 24, 2011 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiaries Shire LLC and Shire Development Inc. (collectively “Shire”) have received a new Paragraph IV Notice Letter from Watson Laboratories, Inc. in Fort Lauderdale, Florida (“Watson”) advising of the filing of an Abbreviated New Drug Application (“ANDA”) for a generic version of all approved strengths of Shire’s ADDERALL XR® (mixed salts of a single-entity amphetamine product) dextroamphetamine sulphate, dextroamphetamine saccharate, amphetamine aspartate monohydrate, amphetamine sulphate capsules, CII.

The new ANDA that Watson filed is not covered under the existing settlement agreements entered into in November 2007 between Shire and Watson (the “Settlement Agreements”).  The Settlement Agreements cover a different ANDA and do not provide any license for Watson to sell the products covered in Watson’s new ANDA.

ADDERALL XR® is protected by the following FDA Orange Book listed patents:  U.S. Reissued Patent RE41,148, which is a reissue of U.S. Patent No. 6,605,300, and U.S. Patent No. 6,322,819, which has recently reissued as U.S. Reissued Patent RE42,096.
Patent protection will expire in April 2019.

Shire is currently reviewing the details of Watson’s Paragraph IV Notice Letter which was directed to each of the Orange Book listed patents.  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 stay of approval of up to 30-months will be imposed by the FDA on Watson’s ANDA.

Shire submitted a Citizen Petition (CP) to the FDA in October 2005 requesting that the FDA impose stricter bioequivalence standards before approving any ANDA for ADDERALL XR®. The FDA responded that the CP raised “complex issues” and has not resolved the matter. The FDA has not approved any ANDA for ADDERALL XR®.
 
For further information please contact:
 
Investor Relations
Eric Rojas (erojas@shire.com)
+1 781 482 0999
     
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
 
 
Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX
 
 

 
 
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 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 dem and; 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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