-----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, V9ABjai9TPKdctKmuB38y5dW5JRcJ1dhXrN3rSgCpcLVS1zE/U10lerkX2+fGiZs NdyLF3XYn6A2bx6pGBbFuw== 0000950103-06-002103.txt : 20060908 0000950103-06-002103.hdr.sgml : 20060908 20060908150729 ACCESSION NUMBER: 0000950103-06-002103 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20060907 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060908 DATE AS OF CHANGE: 20060908 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Shire 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: 061081664 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 ZIP: - BUSINESS PHONE: 1264333455 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 ZIP: - FORMER COMPANY: FORMER CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP PLC DATE OF NAME CHANGE: 19980302 8-K 1 dp03496_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):  September 7, 2006

Shire plc

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

(State or other jurisdiction of incorporation)

0-29630   98-0484822
(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 plc has issued the press releases attached as Exhibit 99.01, Exhibit 99.02 and Exhibit 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 September 7, 2006
99.02 Press Release dated September 8, 2006
99.03 Press Release dated September 8, 2006






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 PLC
     
By:  /s/ A C Russell
 
  Name: Angus Russell 
  Title: Chief Financial Officer
Dated: September 8, 2006




EXHIBIT INDEX


Number Description
   
99.01 Press Release dated September 7, 2006
99.02 Press Release dated September 8, 2006
99.03 Press Release dated September 8, 2006



EX-99.1 2 ex-9901.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  
   

7 September 2006

Shire plc ("Shire")

Purchase of Shares by Employee Benefit Trust

Shire has been notified that on 7 September 2006, the Shire plc Employee Benefit Trust (the “Trust”) purchased 200,000 Ordinary Shares of Shire plc (“Shares”) at an average price of 856.9183 pence per Share. This purchase was made pursuant to the Trustee’s irrevocable, non-discretionary programme to purchase Shares during the period commencing 16th August 2006 to 30th September 2006.

All of the employees of Shire plc and its subsidiaries, including the Executive Directors and persons exercising managerial responsibility, are potential beneficiaries of the Trust. The Executive Directors and persons exercising managerial responsibility over Shire are therefore deemed to have an interest in the Shares held by the Trust.

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
   
Notes to editors    
   
SHIRE PLC    

Shire’s strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.

Shire’s focused strategy is to develop and market products for specialty physicians. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.

For further information on Shire, please visit the Company’s website: www.shire.com.

Registered in England 2883758 Registered Office as above





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  Exhibit 99.02
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  
   

Shire Provides Update on U.S. Marketing Application of
MESAVANCETM (mesalamine) with MMX technology

Philadelphia, PA, US and Basingstoke, UK – September 8, 2006 -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that the Food and Drug Administration (FDA) has extended by 90 days the review period for the new drug application (NDA) for MESAVANCETM. This extension has been sought by the FDA to allow additional time to review supplemental Phase I data recently submitted by Shire. Shire and FDA agreed prior to submission that this data would be submitted during the review process. The FDA advised us at close of US business yesterday that the new action date for the application is January 21, 2007.

“Shire will continue to work closely with the FDA during this brief extension of the MESAVANCE NDA review,” said Matthew Emmens, Chief Executive Officer of Shire. “We still anticipate MESAVANCE will be approved and launched in the US and Europe during the first quarter 2007.“

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 PLC    

Shire’s strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on central nervous system, gastrointestinal, general products and human genetic therapies - all being areas in which Shire has a commercial presence. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results. Shire’s strategy is to develop and market products for specialty physicians. Shire’s in-licensing and merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.

For further information on Shire, please visit the Company’s website: www.shire.com.

Registered in England 2883758 Registered Office as above






"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION
REFORM ACT OF 1995

Statements included herein that are not historical facts are forwarding-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 plc'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 plc's Attention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents, including but not limited to, legal challenges relating to Shire plc's ADHD franchise; government regulation and approval, including but not limited to the expected product approval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE™ (mesalamine with MMX technology) (SPD476) (ulcerative colitis), ELAPRASE™ (I2S) (Hunter syndrome) and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; Shire plc's ability to benefit from the acquisition of Transkaryotic Therapies Inc.; Shire plc's ability to secure new products for commercialization and/or development; and other risks and uncertainties detailed from time to time in Shire plc's and its predecessor registrant Shire Pharmaceuticals Group plc's filings with the US Securities and Exchange Commission, including Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.

About Giuliani S.p.A.

Giuliani S.p.A., founded in 1889, is a privately owned specialty pharmaceutical company with Headquarters in Milan, Italy. It develops new products with high unmet medical need and substantial market opportunity. It is focused on developing and marketing products for the treatment and management of gastrointestinal (ulcerative colitis and Crohn’s disease), metabolic (food intolerance) and dermatological (hair loss) disorders. Shire has licensed from Giuliani S.p.A. the exclusive right to develop and commercialize SPD476 in the US, Canada and Europe (excluding Italy). Giuliani S.p.A. retains the development and commercialization rights to SPD476 in Italy.

# # #

Registered in England 2883758 Registered Office as above






EX-99.3 5 ex-9903.htm
  Exhibit 99.03
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  
   

8 September 2006

Shire plc ("Shire")

Purchase of Shares by Employee Benefit Trust

Shire has been notified that on 8 September 2006, the Shire plc Employee Benefit Trust (the “Trust”) purchased 136,000 Ordinary Shares of Shire plc (“Shares”) at an average price of 850.1917 pence per Share. This purchase was made pursuant to the Trustee’s irrevocable, non-discretionary programme to purchase Shares during the period commencing 16th August 2006 to 30th September 2006.

All of the employees of Shire plc and its subsidiaries, including the Executive Directors and persons exercising managerial responsibility, are potential beneficiaries of the Trust. The Executive Directors and persons exercising managerial responsibility over Shire are therefore deemed to have an interest in the Shares held by the Trust.

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
   
Notes to editors    
   
SHIRE PLC    

Shire’s strategic goal is to become the leading specialty pharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire believes that a carefully selected portfolio of products with a strategically aligned and relatively small-scale sales force will deliver strong results.

Shire’s focused strategy is to develop and market products for specialty physicians. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.

For further information on Shire, please visit the Company’s website: www.shire.com.

Registered in England 2883758 Registered Office as above


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