-----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, T+aZHYaJdz7iA0W54Vz3k22Xk664L7opwFRU3jR4yX7GrPvCw99VifFvi6iT9Jne dnb3h+xX9UTNgtVg8otglQ== 0000950103-05-001234.txt : 20050415 0000950103-05-001234.hdr.sgml : 20050415 20050415133150 ACCESSION NUMBER: 0000950103-05-001234 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20050415 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050415 DATE AS OF CHANGE: 20050415 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: 05753073 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 apr1505_8k.htm feb0305_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):   April 15, 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 releases attached as Exhibits 99.01, 99.02 and 99.03 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 April 15, 2005
99.02
   Press Release dated April 15, 2005
99.03
    Press Release dated April 15, 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 thereunto duly authorized.

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

Dated: April 15, 2005

 






EXHIBIT INDEX

Number Description
 
99.01 Press Release dated April 15, 2005
99.02 Press Release dated April 15, 2005
99.03 Press Release dated April 15, 2005




EX-99.1 2 ex9901.htm ex9901

EXHIBIT 99.01

Shire Pharmaceuticals Group plc
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

 

Court Sets New Trial Date For Impax Cases - - February 2006

Basingstoke, UK and Philadelphia, US – April 15, 2005 – Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) remains committed to protecting the patents which it has relating to ADDERALL XR®, its product for treatment of Attention Deficit Hyperactivity Disorder (ADHD).

Shire has previously announced two pending suits against Impax Laboratories, Inc. based on a first Impax Paragraph IV notice letter for a 30 mg generic version of ADDERALL XR and a second Paragraph IV notice letter for 5 mg, 10 mg, 15 mg, 20 mg and 25 mg generic versions of ADDERALL XR. The Delaware District Court had set an October 11, 2005 trial date for the first Impax case. Following a conference with the same Court in the second case, the Court has now set a consolidated February 23, 2006 trial date for both cases.

Also, as previously announced, Shire has received Paragraph IV notice letters advising of the filing of Abbreviated New Drug Applications (ANDAs) for generic versions of ADDERALL XR from Barr Laboratories Inc., Colony Pharmaceuticals Inc. and Teva Pharmaceuticals USA, Inc. Shire has filed lawsuits against Barr, the first company to send a notice letter, and has chosen not to sue Colony and Teva.

Barr, Impax, Colony and Teva may not launch a generic version of ADDERALL XR before receiving final approval of their respective ANDAs from the US Food and Drug Administration (FDA). Should Barr receive a tentative approval from the FDA, it cannot lawfully launch its generic version before the earlier of the expiration of the currently pending 30-month stays or a district court decision in its favor. Neither Impax, Colony nor Teva will be able to lawfully launch a generic version of ADDERALL XR without the necessary final approval from the FDA and the expiration of the "first to file's" exclusivity rights. The FDA may grant 180 days of generic market exclusivity to the "first to file".

The Barr court case is scheduled to go to trial in January 2006. In the Barr case, the 30 month stay for the '819 patent began in January 2003 and with respect to the '300 patent it began in August 2003.






The Impax 30 month stay for the 30 mg product began in November 2003 and for the new strengths of 5 mg, 10 mg, 15 mg, 20 mg and 25 mg in December 2004.

ADDERALL XR is an important product in Shire's portfolio of treatments for ADHD and is protected by two patents which expire in 2018: Shire Laboratories' U.S. Patent No. 6,322,819 ("the '819 patent") and U.S. Patent No. 6,605,300 ("the '300 patent").

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
 
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.

"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 & 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 Health Canada's suspension of ADDERALL XR sales in Canada and the expected product approval dates of METHYPATCH® (MTS) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476 (ulcerative colitis), SPD 480 (ulcerative colitis) and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Agency in the United States, Shire's ability to secure new products for 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 ended December 31, 2004






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EXHIBIT 99.02

Shire Pharmaceuticals Group plc
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

 

FIRST QUARTER 2005 RESULTS DATE NOTIFICATION – 29th April

Basingstoke, UK – 15 April 2005 – Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY; TSX: SHQ) will announce first quarter 2005 earnings on Friday, 29 April 2005.

  Results announcement time: 12:00 BST / 07:00 EST
  Conference call time: 14:00 BST / 09:00 EST

Live conference call:
Matthew Emmens, Chief Executive Officer and Angus Russell, Chief Financial Officer will host the live conference call at 14:00 BST/09:00 EST.

Please RSVP ssalah@uk.shire.com (T: +44 (0)1256 894 160).

The details of the live conference call are as follows:

  UK dial in +44 (0) 1452 568 061
  US / Canada dial in 1866 224 2972
  Password Shire

Live Webcast:
The call will also be available live over the Internet via audio webcast, accessible through www.shire.com in the investor relations section. A slide presentation to accompany the call will also be available on the Shire website.

Replay:
A replay of the presentation will be available for two week. Details are as follows:

  UK dial in +44 (0) 0845 245 5205
  US dial in +18662474222
     
  Stnd Int Dial In Number +44 (0) 1452 55 00 00
  Pin code 5538901#
     
  Webcast Replay www.shire.com, in the investor relations section

If you have any problems accessing this, please contact: Souheil Salah on: +44 (0) 1256 894160







For further information please contact:
     
Investor Relations Souheil Salah (Rest of the World) +44 1256 894 160
                                                          Heidi Wunder (North America) +1 484 595 8709
   
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.

“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 & 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 NRP104, including its scheduling classification by the Drug Enforcement Agency in the United States, Shire’s ability to secure new products for development, , the implementation of the current reorganization and other risks and uncertainties detailed from time to time in Shire’s filings, including its Annual Report on Form 10-K for the year ended December 31, 2003, with the Securities and Exchange Commission.






EX-99.3 5 ex9903.htm ex9903

EXHIBIT 99.03

Shire Pharmaceuticals Group plc
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

 

PRODUCT DEVELOPMENT UPDATE SESSION – May 10th

Basingstoke, UK and Philadelphia, US – April 15, 2005 – Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) will host a product development update teleconference on Tuesday, May 10, 2005 beginning at 14:00 BST/09:00 EST.

Live conference call:
Eliseo Salinas, Chief Scientific Officer and Greg Flexter, Executive Vice President and General Manager, North America, will host the call. The presentation will focus on three key Shire development candidates: MTS (ADHD), SPD503 (ADHD) and SPD476 (ulcerative colitis).

Please RSVP via:
Souheil Salah ssalah@uk.shire.com (T: +44 (0)1256 894 160)
Heidi Wunder
hwunder@us.shire.com (T: +1 484 595 8709)

The details of the live conference call are as follows:

  UK dial in +44 (0) 1452 568 061
  US / Canada dial in +1 866 224 2972
  Password Shire

Live Webcast:
The call will also be available live over the Internet via audio webcast, accessible through www.shire.com in the Investor Relations section. A slide presentation to accompany the call will also be available on the Shire website.

Replay:
A replay of the presentation will be available for two week. Details are as follows:

  UK dial in +44 0845 245 5205
  US dial in +1 8662474222
  Stnd Int Dial In Number +44 (0) 1452 550 000
  Pin code 5617240#
  Webcast Replay www.shire.com, in the investor relations section

If you have any problems accessing this, please contact: Souheil Salah on: +44 (0) 1256 894160 or Heidi Wunder on: +1 484 595 8709

 

Registered in England 2883758 Registered Office as above






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For further information please contact:
     
Investor Relations Souheil Salah (Rest of the World) +44 1256 894 160
Heidi Wunder (North America) +1 484 595 8252

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.

"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 & 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 Health Canada's suspension of ADDERALL XR sales in Canada and the expected product approval dates of METHYPATCH® (MTS) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476 (ulcerative colitis), SPD 480 (ulcerative colitis) and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Agency in the United States, Shire's ability to secure new products for 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 ended December 31, 2004

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