-----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, Pw5Owdc+hDzgVPAiJZuVBlCOYZ/Wi9ngWounCto0XSn1TWhUtpVudQAXAAKMfUNL 8Hf8ziDz7KYx7wfgRcBh0A== 0000950103-06-002304.txt : 20061004 0000950103-06-002304.hdr.sgml : 20061004 20061004071731 ACCESSION NUMBER: 0000950103-06-002304 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 10 CONFORMED PERIOD OF REPORT: 20060928 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061004 DATE AS OF CHANGE: 20061004 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: 061126757 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 dp03642_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 28, 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, Exhibit 99.03, Exhibit 99.04, Exhibit 99.05, Exhibit 99.06, Exhibit 99.07 and Exhibit 99.08 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  28, 2006   
99.02    Press Release dated September  29, 2006   
99.03    Press Release dated September  29, 2006 
99.04    Press Release dated October  2,  2006
99.05    Press Release dated October  3,  2006 
99.06    Press Release dated October  3,  2006 
99.07   Press Release dated October  3,  2006
99.08   Press Release dated October  3,  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: October 3, 2006






EXHIBIT INDEX


Number Description
   
99.01  Press Release dated September  28, 2006   
99.02  Press Release dated September  29, 2006   
99.03  Press Release dated September  29, 2006 
99.04  Press Release dated October  2,  2006
99.05  Press Release dated October  3,  2006 
99.06  Press Release dated October  3,  2006 
99.07 Press Release dated October  3,  2006
99.08 Press Release dated October  3,  2006





EX-99.1 2 dp03642_ex9901.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  
   

28 September 2006

Shire plc ("Shire")

Purchase of Shares by Employee Benefit Trust

Shire has been notified that on 28 September 2006, the Shire plc Employee Benefit Trust (the “Trust”) purchased 135,000 Ordinary Shares of Shire plc (“Shares”) at an average price of 881.8093 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

Registered in England 2883758 Registered Office as above






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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MCB>WM->M7.I:#XHT:S>-_#NOB-XTNK*VNKB22?3I(G\BYM)9\7$>3NCD6-X= M\HSBMDF.^M8--T7[M2E.7\2FW>TFDDI7UC)+W7W5TYKX>->GR3TE'5-*UGZ= MNZZGX(?%O]D#X\_!Z]O(]9\#ZEXE\/0._P!G\6^#+.Z\0:)=6P9E2:X@LX7O M=(=E&3#>V\6,X#N,,W[#EO$N3YC"+HXN.&K=:-:2I33ZI-M1GZPD[]EL>%5P ME>BW>#%6OB3QMH41TRQ\1>-=#@CRATRTUKQ%I4,>>#&;"&ZB M6/J1M\L=>E>O*AA*CYY4*%5_S.%.3_\``FG^9@I3CHI2BNR;7X'4^#/@_P#% MWXH:F(?!W@#QGXIO;N1#-J/]EZ@MF#(0HGU#7]46*TACYR9)[H<>M<^*S++< MOIWQ.,H8:,=H<\>;TC3A>5_)1+A1JS=H4Y/SLTOFWHC]N/V,_P!BY?@&\OC_ M`,?7-AJWQ/U*P>PM+73V\_2?!NFW84WMK9W;HIO]7N5"Q7%XBI&D:M#!N222 M2;\IXHXH_M=+!8*,J6`IRYFY>[.M)?"Y1^S".\8[M^]+5)+V<'@_J_OSM[1J MR2VBGO;S[O[C\K/VB/A#\6=4^/'QAU/2OA=\0]1TV_\`B+XJN[#4+#P;X@N[ M&]M9]5N'AN;2Z@L&CN+>1"&61&96!!!(K]"R3,LMI9/EE.>88:G.&&I*495Z M<91:@KIIR3375,\O$4:OMZSC2G;GE:T7;?T/VF_8@T/6O#7[,OPYT;Q#H^J: M!J]G_P`)+]JTK6;"YTS4;7SO%6LSP_:+*\BCEA\R&2.1=R#S@HN.&IQDG%KFT:L_B?0N?MI MZ+K/B']F7XH:-X?TG4M]LM!6STK1[&YU'4;MHO%6ASRK;65I&\LQ2&.21 M@B'"QLQX!-1PM5I8?/LOJ5JD:%*$JEY3DH1C>E42NVTE=M+S;#&1;PU6,4V] M+)+7XET1^)G[._PA^+.D_'GX.ZGJ?PN^(>F:;I_Q&\*7=]J%_P"#?$%G8V5K M#JMN\]S=W4]@L=M;QH"S2.RJH!)(%?JN=YEEL\GS.G2S##3G+#5E&,:U-R;< M'9**E=M]$MSQL/1JQKT6Z4XI37V6DM?0W/VJ?A+\5=9_:+^+^K:+\,OB!JVE M7WC&ZN+#4M,\(:]?:?>0-:V:K/:7=M8O%<1%E8!T9AD'GBLN'LQRZCDF64JF M/P]*I"BE*$JU.,HN[T<7)-/U16*HU?K%5QI2MS:-1=OR/5O'OPS^)%Q^PW\# M?#=K\/O&UQXBTWXH>,+W4=`@\+ZU)K.GV=Q)XD,%W>Z8EF;BUMI1-%LDDC56 M\U,$[AGSL'C\##BS-JSQM"-">$HQC4=6"A*2]E=1ES]T&?L`_#+XD^%_VD=#U?Q+\/?&WAS28O"GB^"34]<\+:UI.G MQS7%A$L$+WE[9QQ)+(P(12P+$8`-/C''X&MD56EA\;0JU/;46H4ZL)RLI.[Y M8R;LNN@8"E4AB8N5.4$HRU<6EL?O37X^>X?G?^VE^Q=+\QL/B=I MUC'8ZCIM]*MEIWC73;52+*&6](V6&NVJ$Q07,P\J6(I#.T:Q1R1_:\+<4+)T M\#C5*6`G+FC**O*A)_$U'[5.6\HK5.\HIMM/S\9@_:_O*5E46EME)+\GV9^- MW]D?M"?L_P"OW(AL/BE\*]1RXC#2T4Z3\KK\M&+=?\-#_ M`!]U>RL[Y/BO\5-4A?9807L.OZQ;6+/\K/'Y\:V&EK@_/,QA`&2[`9I1_L7) MJ4I0^J9;3?Q.+IP;^Y\\O):^2#_:*S2?/4:VW=OT1^QG[$G[&MY\#?M/Q'^) M`LIOB7JM@^GZ9I-G+'>6G@K2+K:U[$;U,QW>O7@5(YY8"8H85,,4D@FE9OS+ MBOB>.:\N!P/-'`4Y[?\``/\`T(54=P&V7^H_X$U$MP18J0"@#__9 ` end EX-99.2 4 dp03642_ex9902.htm
  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  
   

29 September 2006

Shire plc ("Shire")

Purchase of Shares by Employee Benefit Trust

Shire has today been notified by Towers Perrin Share Plan Services (Guernsey) Ltd (the “Trustee”) as trustee of Shire plc Employee Benefit Trust (the “Trust”) that it will commence an irrevocable, non-discretionary programme to purchase Ordinary Shares of Shire plc (“Shares”) and American Depositary Receipts of Shire plc (“ADR’s”) for the benefit of the Trust during the period commencing on 02 October 2006 and ending on 23 February 2007.

Any purchases will be conducted within certain pre-set parameters agreed between the Trust and an independent third party broker.

   
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.

Registered in England 2883758 Registered Office as above






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






EX-99.3 5 dp03642_ex9903.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  
   

29 September 2006

Shire plc ("Shire")

Purchase of Shares by Employee Benefit Trust

Shire has been notified that on 29 September 2006, the Shire plc Employee Benefit Trust (the “Trust”) purchased 137,984 Ordinary Shares of Shire plc (“Shares”) at an average price of 887.0561 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


Registered in England 2883758 Registered Office as above






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






EX-99.4 6 dp03642_ex9904.htm
  Exhibit 99.04
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  
   

2 October 2006

Shire plc (the “Company”)

Director Shareholding

The Company was notified on 2 October 2006 that, on 29 September 2006, Kate Nealon purchased 2251 ordinary shares of 5p each in the Company at 888p per share.

As a result of this transaction Ms Nealon is interested in 2251 ordinary shares representing 0.0004% of the issued share capital of the Company

T May       
Company Secretary       
       
       
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.

 

Registered in England 2883758 Registered Office as above





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






EX-99.5 7 dp03642_ex9905.htm
  Exhibit 99.05
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  
   

3 October 2006

Shire plc (the "Company")

Notification of the Exercise of an Option and Sale of Shares by a Person Discharging Managerial Responsibilities

The Company announces that on 26 September 2006 it was notified of the exercise in London on the same day by Mr John Lee, Executive Vice President Global Supply Chain & Quality, of an option over 36,466 ordinary 5p shares in the capital of the Company at an exercise price of £5.25.

The Company further announces that on 26 September 2006 it was notified of the sale in London on the same day by Mr Lee of the same 36,466 ordinary 5p shares in the capital of the Company at a price of £8.50.

Following these transactions, Mr Lee holds options over 391,150 ordinary 5p shares in the capital of the Company.

T May
Company Secretary

   
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),

 

Registered in England 2883758 Registered Office as above






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






EX-99.6 8 dp03642_ex9906.htm
  Exhibit 99.06
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  
   

ADDERALL XR® - Paragraph IV notice received

Basingstoke, UK and Philadelphia, US – October 03, 2006 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) - announces that it has received a Paragraph IV notice letter from Andrx Pharmaceuticals, L.L.C. (Andrx) advising of the filing of an Abbreviated New Drug Application (ANDA) for its amphetamine combination product, a generic version of Shire’s mixed amphetamine salt product, ADDERALL XR®.

Shire is currently reviewing the details of the Paragraph IV Notice letter from Andrx.

Shire has received Paragraph IV Notice letters from Barr Laboratories, Inc. (Barr), IMPAX Laboratories, Inc. (IMPAX), Colony Pharmaceuticals, Inc. (Colony), and Teva Pharmaceuticals USA, Inc. (Teva). As previously announced, Shire filed lawsuits against Barr, Impax and Teva. The Barr and Impax lawsuits have been settled. The Teva litigation is ongoing in United States District Court of Pennsylvania.

Andrx may not launch a generic version of ADDERALL XR® before it receives final approval of its ANDA from the U.S. Food and Drug Administration (FDA). If Shire decides to file a complaint on this Paragraph IV Notice letter, the lawsuit triggers a stay of FDA approval of up to 30 months from the Company’s receipt of Andrx’s notice to allow the Court to resolve the suit. Even if Andrx receives a tentative approval from the FDA, it can not lawfully launch its generic version before the earlier of the expiration of the relevant stay, a district court decision in its favor and the expiration of any exclusivity rights that may attach to earlier filed ANDAs. The FDA may grant 180 days of generic market exclusivity to the “first to file.”

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 and U.S. Patent No. 6,605,300.

 

 

Registered in England 2883758 Registered Office as above






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 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.

"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 CONNEXYN™ (SPD503) (ADHD), SPD465 (ADHD), MESAVANCE ™ (SPD476) (ulcerative colitis), and NRP104 (ADHD), including its scheduling classification by the Drug Enforcement Administration in the United States; 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, particularly Shire plc's Annual Report on Form 10-K for the year ended December 31, 2005.

 

 

Registered in England 2883758 Registered Office as above






EX-99.7 9 dp03642_ex9907.htm
  Exhibit 99.07
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 in-licenses development rights to tissue protective
cytokine technology from Warren Pharmaceuticals

Philadelphia, PA, US and Basingstoke, UK – October 3, 2006 -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces today that it has in-licensed rights to tissue protective cytokine (TPC) technology under an agreement with Warren Pharmaceuticals, Inc. The agreement gives Shire exclusive worldwide rights to develop TPCs in non-Nervous System indications, including renal and genetic disease areas.

Erythropoietin (EPO) is produced by the kidneys and regulates red cell production. EPO’s have been shown to be effective when administered to boost red blood cell counts of patients with both renal and chemotherapy-induced anemia¹. There is considerable evidence that EPO also protects against cell death². Warren Pharmaceuticals has identified TPCs, which are modifications of EPO, which down-regulate the effect on blood cell production while maintaining its tissue protective effects, potentially making the therapy useful in a wide variety of disease areas. Furthermore, TPCs have been shown, in animal models, to prevent cell-death (anti-apoptotic), reduce inflammation (anti-inflammatory), and improve auto-regulation of blood vessels in a number of tissues³.

“The technology developed by Warren Pharmaceuticals provides an excellent strategic fit within our Human Genetic Therapies and Renal businesses, with the potential to build a franchise around TPCs in a broad range of indications,” said Shire Chief Executive Matthew Emmens.

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 

 

 

Registered in England 2883758 Registered Office as above






Notes to editors

1Recombinant erythropoietin in clinical practice; T Ng, G Marx, T Littlewood and I Macdougall 2003 Prostgrad Med J
2Erythropoietin mediates tissue protection through an erythropoietin and common ß-subunit heteroreceptor; Michael Brines PANS 2004
3Derivatives of Erythropoietin That are tissue protective but not erythropoietic; Marcel Leist 2004 sciencemag

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.

"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.

WARREN PHARMACEUTICALS, INC.

Warren Pharmaceuticals, Inc. is a privately held biotech company that was incorporated in 2001 for the purpose of developing proprietary tissue-protective technologies.

Warren Pharmaceuticals, Inc. is located in Westchester County, New York, 30 miles north of New York City. Warren Pharmaceuticals was named in honor of the late Kenneth S. Warren, M.D.

For further information on Warren, please visit theCompany’swebsite: www.warrenpharmaceuticals.com 


Registered in England 2883758 Registered Office as above




EX-99.8 10 dp03642_ex9908.htm
  Exhibit 99.08
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  
   

3 October 2006

Shire plc (the “Company”)

The Company announces that it was notified on 3 October 2006 under Sections 198 to 202 of the Companies Act that FMR Corp. and its direct and indirect subsidiaries and Fidelity International Limited and its direct and indirect subsidiaries, both being non-beneficial holders, held solely for investment purposes, in aggregate 25,980,779 ordinary shares of £0.05p each in the capital of the Company. These holdings represent 5.17 per cent of the issued ordinary share capital of the Company.

T May       
Company Secretary       
       
       
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.

 

Registered in England 2883758 Registered Office as above






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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