-----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, D2OJqx/IhNYtWqDi3cnjtSzjO5aVCdbLPb0o7JZCzRPJDEXRtckb922k1pXbqVrc sDB0frON+V1oHVuOscmKiQ== 0000950103-04-001725.txt : 20041202 0000950103-04-001725.hdr.sgml : 20041202 20041202134827 ACCESSION NUMBER: 0000950103-04-001725 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20041202 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041202 DATE AS OF CHANGE: 20041202 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: 041179952 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 dec0204_8k.htm 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):                     December 2, 2004

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 December 2, 2004







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: December 2, 2004    

 





EXHIBIT INDEX

Number Description
99.01 Press Release dated December 2, 2004
   





EX-99.01 2 dec0204_ex99-01.htm item9901

 

Shire Pharmaceuticals Group plc
Hampshire International Business Park,
Chineham, Basingstoke RG24 8EP UK
Tel +44 1256 894000 Fax +44 1256 894708
http://www.shire.com


ADDERALL XR
® - Paragraph IV notice received

Basingstoke, UK and Philadelphia, US – 2 December 2004 Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that it has received a Paragraph IV Notice letter from Colony Pharmaceuticals Inc., advising of the filing of an Abbreviated New Drug Application (ANDA) for its amphetamine combination product, a generic version of Shire's mixed amphetamine salts product, ADDERALL XR®.

ADDERALL XR is the lead product in Shire’s portfolio of treatments for Attention Deficit and Hyperactivity Disorder (ADHD) and is protected by two patents which expire in 2018: Shire Laboratories' U.S. patent No. 6,322,819 (“819” Patent) and U.S. patent No. 6,605,300 (“300” Patent).

Shire received Paragraph IV Notice letters from Barr Laboratories Inc. and IMPAX Laboratories Inc. in 2003 relating to their ANDAs for their respective generic versions of ADDERALL XR and, as previously announced, Shire has filed lawsuits in response to the Barr and IMPAX ANDA Notice letters.

Shire is currently reviewing the detail of the Paragraph IV Notice letter from Colony Pharmaceuticals Inc.

-ends-

For further information please contact:

Investor Relations
Cléa Rosenfeld (Global) +44 1256 894 160
   
Media  
Jessica Mann (UK and Europe) +44 1256 894 280
Matthew Cabrey (US) +1 484 595 8248
   
   
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 projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI) and renal diseases. 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




THE 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 on Shire's Attention Deficit & 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 METHYPATCH® (methylphenidate) and BIPOTROL® (carbamazepine), the implementation of Shire's planned reorganization and other risks and uncertainties detailed from time to time in Shire’s filings with the Securities and Exchange Commission, including Shire's most recent annual report on Form 10-K.




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