-----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, RB+IIBstN4qmGA/j6E4tE7WyChHxC8BUpUVhsED4o7WSro3h6Bcxiw33qK48qRXU kd3a2rfQIw7nKoGruYhHrQ== 0000950103-08-000574.txt : 20080304 0000950103-08-000574.hdr.sgml : 20080304 20080304060120 ACCESSION NUMBER: 0000950103-08-000574 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20080303 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080304 DATE AS OF CHANGE: 20080304 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: 08661775 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 dp08944_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): March 3, 2008

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 hereto as Exhibit 99.01 and Exhibit 99.02 which are incorporated by reference herein.

Item 9.01.  Financial Statements and Exhibits

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

99.01  
Press Release dated March 3, 2008
99.02
Press Release dated March 3, 2008


 
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: March 3, 2008
 

 
EXHIBIT INDEX
 
Number
Description
   
99.01
99.02
Press Release dated March 3, 2008
Press Release dated March 3, 2008
 
 
 

 
 
EX-99.1 2 dp08944_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  
 
 
Renovo announces results of latest Phase 2 studies of JUVISTA® (human recombinant TGFβ3)

 
Basingstoke, UK and Philadelphia, US – March 3, 2008 – Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, notes that Renovo Group plc, (LSE: RNVO) (“Renovo”) has today announced the results of Renovo’s latest Phase 2 studies of JUVISTA® (human recombinant TGFβ3) in scar revision surgery (RN1001-319-1009) and in breast augmentation (RN1001-319-1010).

Renovo’s press release can be found on http://www.renovo.com.

The two trials announced by Renovo are part of a broad global Phase 2 clinical program to assess the safety, efficacy, dose and dose frequency of JUVISTA in a variety of surgical procedures.

Shire is at present assessing these latest results with all other results produced to date and plans to discuss these with the US Food and Drug Administration (FDA) in 2008 to determine the regulatory path forward in the United States.

-end-
 
For further information please contact:

Investor Relations  
Cléa Rosenfeld (Rest of the World)  
+44 1256 894 160
 
Eric Rojas (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

Financial terms of the agreement with Renovo
 
 
Registered in England 2883758  Registered Office as above
 
 
 

 
 
Under the terms of the agreement with Renovo, Shire has the exclusive right to commercialize JUVISTA worldwide, with the exception of EU member states.

As previously announced, Shire will bear the cost of clinical trials designed specifically for obtaining US regulatory approval.  Renovo will bear the costs of clinical trials designed specifically for obtaining EU regulatory approval.  Shire and Renovo will share equally the costs of conducting global clinical trials that are designed for obtaining both US and EU regulatory approvals.

The financial terms of the agreement are geared to the success of the development and commercialization of JUVISTA.  Shire has paid Renovo US$75 million cash upfront (expensed as R&D for US GAAP purposes) and made an equity investment in Renovo Group plc of US$50 million (at a subscription price of £2 per share, which at the date of the original announcement represented approximately 7% of Renovo’s share capital).

On the FDA’s acceptance of the filing of the biologics license application for JUVISTA, Shire will pay US$25 million and on FDA approval, between US$50 and US$150 million depending on the characteristics of the approved product labelling.  In addition, Shire will pay to Renovo royalties on sales of JUVISTA and milestone payments of up to US$525 million on the achievement of significant sales targets.

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical 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’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.  Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

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 including, but not limited to, the successful development of JUVISTA® (Human TGFβ3) and GA-GCB (velaglucerase alfa); manufacturing and commercialization including, but not limited to, the launch and establishment in the market of VYVANSE™(lisdexamfetamine dimesylate) (Attention Deficit and Hyperactivity Disorder (“ADHD”)); the impact of competitive products including, but not limited to, the impact of those on Shire’s ADHD franchise; patents including, but not limited to, legal challenges relating to Shire’s ADHD franchise; government regulation and approval including, but not
 
 
Registered in England 2883758  Registered Office as above
 
 
 

 
 
limited to, the expected product approval date of INTUNIV™ (guanfacine extended release) (ADHD); Shire’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 filings with the Securities and Exchange Commission, particularly Shire plc’s Annual Report on Form 10-K for the year ended December 31, 2007.

 
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  
 
Total Voting Rights

 
Basingstoke, UK and Philadelphia, US – 3 March 2008– Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, in accordance with DTR 5.6.1 of the FSA’s Disclosure and Transparency Rules, notifies the market of the following:

At close of business on 29 February 2008, Shire plc's issued voting share capital consisted of 559,342,033 ordinary shares with a nominal value of 5 pence.  Each ordinary share carries one voting right.  Shire plc does not hold any shares in Treasury.

The above figure (559,342,033) may be used by shareholders as the denominator for the calculations by which they will determine if they are required to notify their interest in, or a change to their interest in, Shire plc under the FSA's Disclosure and Transparency Rules.
 
T May
Company Secretary
 

For further information please contact:

Investor Relations  
Cléa Rosenfeld (Rest of the World)  
+44 1256 894 160  
 
Eric Rojas (North America)
+1 484 595 8252

 
Notes to editors

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical 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’s
 
 
Registered in England 2883758  Registered Office as above
 
 
 

 
 
in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe.  Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

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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