-----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, IU8Ld1i3SSkmLmGL8obmZQbMOMlw2PRkq3vLRJShfEs/MjvDFdp76NoG94eBA5sP pu5F5tWj0phEkpzNUj8Tnw== 0000950103-03-002187.txt : 20031119 0000950103-03-002187.hdr.sgml : 20031119 20031119130409 ACCESSION NUMBER: 0000950103-03-002187 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20031118 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031119 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: 031012303 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 nov1903_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): November 18, 2003

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) (I.R.S. 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)





Item 5. Other Events
   
        Shire Pharmaceuticals Group plc has issued the press release attached as Exhibit 99.1 and which is incorporated by reference herein.
   
Item 7. Financial Statements and Exhibits
   
  (c) Exhibit. The following exhibits are filed herewith:
   
99.1 Press Release dated November 18, 2003
   



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:
Title:
Angus Russell
Group Finance Director
       
Dated: November 18, 2003      





EXHIBIT INDEX

Number   Description
     
99.1  

Press Release dated November 18, 2003





EX-99.1 3 nov1903_ex9901.htm press

EXHIBIT 99.1



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 – 18 November 2003 – Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that it has received a Paragraph IV Notice letter from IMPAX Laboratories, Inc. advising of the filing of an Abbreviated New Drug Application (ANDA) for a generic version of 30mg 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 letters from Barr Laboratories Inc. earlier this year relating to their ANDA for a generic version of ADDERALL XR and, as previously announced, Shire has filed lawsuits in response to the Barr ANDA.

Shire is currently reviewing the detail of the Paragraph IV Notice letter from IMPAX.

For further information please contact:

Global (outside US and Canada)      
Cléa Rosenfeld – Investor Relations + 44 1256 894 160  
Jessica Mann – Media + 44 1256 894 280  
US & Canada      
Michèle Roy – Media + 1 450 978 7938  

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 has a range of projects and 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

1



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 date of lanthanum carbonate (FOSRENOL®), METHYPATCH®, XAGRID® and the adult indication for ADDERALL XR® and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K by Shire with the Securities and Exchange Commission.

2


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