-----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, Q8PW/WW/Dd+uQmXq9jbPTAvsvs6vQaZVhQ4+c2Sj2H8DU9EJE+SCgu/q+ACejtJ5 W3qS7Sd9fFxAk48C/vhAlA== 0000950103-05-002192.txt : 20051020 0000950103-05-002192.hdr.sgml : 20051020 20051020110503 ACCESSION NUMBER: 0000950103-05-002192 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20051020 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051020 DATE AS OF CHANGE: 20051020 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP 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: 051146566 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 BUSINESS PHONE: 1264333455 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 8-K 1 oct2005_8k.htm
   
   
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):  October 20, 2005

Shire Pharmaceuticals Group plc

(Exact name of registrant as specified in its charter)
 
England and Wales

(State or other jurisdiction of incorporation)

0-29630   98-0359573
(Commission File Number)   (IRS Employer Identification No.)

Hampshire International Business Park, Chineham, Basingstoke,
Hampshire RG24 8EP England

(Address of principal executive offices)                                                (Zip code)

Registrant’s telephone number, including area code                    44 1256 894 000

 

(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.):
 
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 8.01. Other Events

     Shire Pharmaceuticals Group plc has issued the press release attached as Exhibit 99.01 which is incorporated by reference herein.

Item 9.01. Financial Statements and Exhibits

(c) Exhibits. The following exhibit is filed herewith:
     
99.01   Press Release dated October 20, 2005
     







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 PHARMACEUTICALS GROUP
      PLC
     
By: /s/ A C Russell
 
  Name: Angus Russell
  Title: Chief Financial Officer 

Dated: October 20, 2005

 





EXHIBIT INDEX

Number   Description
99.01   Press Release dated October 20, 2005    








EX-99.1 2 ex9901.htm
    EXHIBIT 99.01
  Hampshire International Business Park
Chineham Basingstoke
Hampshire RG24 8EP
United Kingdom
Tel +44 (0)1256 894000
Fax +44 (0)1256 894708
www.shire.com
     
     
  Press Release  

ADDERALL XR® - Shire Files Legal Suit against Barr
Laboratories and Impax Laboratories for Infringement of
U.S. Patent No. 6,913,768

Basingstoke, UK and Philadelphia, US – October 20, 2005 – Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that its subsidiary Shire Laboratories Inc. has filed a lawsuit in the U.S. District Court of the Southern District of New York against Barr Laboratories, Inc. (“Barr”) and Impax Laboratories, Inc. (“Impax”) for infringement of Shire Laboratories U.S. Patent No. 6,913,768 (“‘768 Patent”).

The lawsuit results from ANDAs (Abbreviated New Drug Applications) filed by Barr and Impax seeking FDA approval to market and sell generic versions of Shire’s 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALL XR® products. The ‘768 patent issued to Shire on July 5, 2005.

The present case should not affect the existing litigation in the Southern District of New York between Shire and Barr involving U.S. Patents Nos. 6,322,819 (‘819) and 6,605,300 (‘300), which is scheduled to go to trial in January 2006. Likewise, the new case against Impax should not affect the ongoing litigation between Shire and Impax in the District Court of Delaware, also involving the ‘819 and ‘300 patents, which is scheduled to go to trial on February 23, 2006.

ADDERALL XR® is Shire’s leading Attention Deficit Hyperactivity Disorder (“ADHD”) medicine.

For further information please contact:
         
Investor Relations   Cléa Rosenfeld (Rest of the World) + 44 1256 894 160
  Brian Piper (North America) + 1 484 595 8252
         
Media   Jessica Mann (Rest of the World) + 44 1256 894 280
  Matthew Cabrey (North America) + 1 484 595 8248



Registered in England 2883758 Registered Office as above






Notes to editors

Shire Pharmaceuticals Group plc

Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), renal diseases and human genetic therapies. Shire has operations in the world’s key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

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, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact of those on Shire's Attention Deficit and Hyperactivity Disorder (ADHD) franchise, patents, including, but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including, but not limited to, the expected product approval dates of MTS (METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476 (ulcerative colitis), I2S (iduronate-2-sulfatase) (Hunter syndrome), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Agency in the United States, Shire’s ability to benefit from its acquisition of TKT, Shire's ability to secure new products for commercialization and/or development and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K for the year to December 31, 2004.

 

 


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-----END PRIVACY-ENHANCED MESSAGE-----