-----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, BIfyEXoPSVLHWSABy11wcPY6+t63Qo2AWUbrCebFqXAO0Zn0B5nF+yIMB3Zlasuu sJukSx21CD9t2Sn5yvhJPw== 0000950103-04-001667.txt : 20041119 0000950103-04-001667.hdr.sgml : 20041119 20041119073152 ACCESSION NUMBER: 0000950103-04-001667 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20041118 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041119 DATE AS OF CHANGE: 20041119 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: 041156296 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 nov1804_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):                     November 18, 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 releases attached as Exhibit 99.01 and Exhibit 99.02 which are incorporated by reference herein.

Item 9.01 Financial Statements and Exhibits

      (c) Exhibits. The following exhibits are filed herewith:

99.01     Press Release dated November 18, 2004; and
99.02     Press Release dated November 18, 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: November 18, 2004    

 





EXHIBIT INDEX

Number Description
99.01 Press Release dated November 18, 2004
99.02 Press Release dated November 18, 2004
   





EX-99.1 2 ex9901.htm ex9901
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



For immediate release
   
   


Shire receives European Union approval for XAGRID®
(anagrelide hydrochloride)

Basingstoke, UK – (Thursday 18 November 2004)– Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today announces that it has received approval for XAGRID® (anagrelide hydrochloride) for second line, monotherapy treatment of essential thrombocythaemia (ET)* in the European Union, Iceland and Norway. Shire will commence a phased launch throughout Europe and expects the drug to be available for prescribing from the New Year.

XAGRID, as anagrelide hydrochloride, was designated as an orphan medicinal product on 29 December 2000 for the treatment of ET, thereby providing the product with up to ten years market exclusivity in Europe from the date of grant of the license.

Essential thrombocythaemia is a chronic disorder of bone marrow, which is associated with the increased production of blood platelets. Excessively high levels of platelets can result in abnormal clotting and bleeding, thereby increasing the risk of stroke and heart attack.

Shire estimates that over 40,000 patients** suffer from ET across the EU. There is currently no other platelet-reducing treatment approved for the treatment of ET across the whole EU.

The drug is already marketed by Shire in the US and eleven other countries under the trademarks AGRYLIN® or XAGRID®. Sales of AGRYLIN in 2003 were $132.5 million.

In addition, the product has been prescribed on a named patient basis in certain territories since 1997.

Says Matthew Emmens, Shire’s Chief Executive:

“XAGRID is a unique medicine for patients suffering from essential thrombocythaemia, a condition that can have debilitating and sometimes life threatening consequences if not treated effectively. Now that XAGRID is approved, and orphan designation confirmed, we can put our full European sales and marketing effort behind its commercialisation across Europe.”

Dr Claire Harrison, Consultant Haematologist at Guy's & St Thomas' Foundation Trust, London adds:

“XAGRID is platelet selective, targeting only those cells that develop into platelets; it is well tolerated by most patients and is a welcome addition to the drugs we have available to treat ET.”




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

Notes to editors

Shire acquired the worldwide rights to XAGRID/AGRYLIN from Bristol-Myers Squibb in June 1999. Japanese marketing and development rights for XAGRID were sold to the Pharmaceutical Division of Kirin Brewery Company Ltd in December 2003.

References:

*The indication approved for XAGRID is “the reduction of elevated platelet counts in at risk essential thrombocythaemia (ET) patients who are intolerant to their current therapy or whose elevated platelet counts are not reduced to an acceptable level by their current therapy.”

** Source: Shire market research

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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Shire Pharmaceuticals Group plc

 

 


STOCK EXCHANGE ANNOUNCEMENT
18 November 2004


Shire Pharmaceuticals Group plc (the “Company”)

The Company announces that it was notified on 18 November 2004 under Sections 198 to 202 of the Companies Act that on 17 November 2004 Franklin Resources, Inc. and its affiliates had holdings managed on behalf of investment clients of 63,016,892 ordinary shares of £0.05p each in the capital of the Company. These holdings represent 13.0117 per cent of the issued ordinary share capital of the Company.

T May
Company Secretary


For further information please contact:
 
Investor Relations
Cléa Rosenfeld +44 1256 894 160

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 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


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