-----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, N5ue+HQRkT20fnYAtTLoDXNHkEbUqFHeVoqO+V8Y74QSmz/h/X7iJUJiA2Q430V1 LArcSZ1cjGjEFpo+nQT2WQ== 0000950103-07-002090.txt : 20070816 0000950103-07-002090.hdr.sgml : 20070816 20070816081538 ACCESSION NUMBER: 0000950103-07-002090 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070815 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070816 DATE AS OF CHANGE: 20070816 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: 071061226 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 dp06649e_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): August 15, 2007

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 release attached hereto as Exhibit 99.01 which is incorporated by reference herein.
 
Item 9.01.  Financial Statements and Exhibits

                  (d)  Exhibits.  The following exhibit is filed herewith:
 
99.01   Press Release dated August 15, 2007
 

 
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: August 15, 2007
 


 
 
EXHIBIT INDEX
 
 
Number
Description
   
99.01
Press Release dated August 15, 2007
 
 
 

 
 
 
EX-99.01 2 dp06649e_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  

Expiry of Hart-Scott-Rodino waiting period for JUVISTA® (human TGFβ3)

 
Basingstoke, UK and Philadelphia, US – August 15, 2007– Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, announces that the waiting period under Hart-Scott-Rodino Antitrust Improvements Act of 1976 with respect to its exclusive license of JUVISTA® (human TGFβ3) from Renovo Group plc (LSE: RNVO) expired on August 10, 2007.  In accordance with its terms, the License Agreement became effective on August 15, 2007.

JUVISTA is a novel biopharmaceutical investigational drug and when injected at the time of surgery has been shown in clinical trials to markedly improve subsequent scar appearance in the skin.

Under the terms of the agreement, Shire has the exclusive right to commercialize JUVISTA worldwide, with the exception of EU member states.  Shire’s financial obligations under the agreement are geared to JUVISTA’s successful development and commercialization.  Shire will now pay Renovo US$75 million upfront (expensed during the third quarter as R&D for US GAAP purposes) and in addition, Shire will make an equity investment in Renovo of US$50 million (at a subscription price of £2 per share, which represents approximately 6.5% of Renovo’s share capital immediately after the issue).

On the FDA’s acceptance of filing of JUVISTA’s biologics license application, 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.  Shire will also pay Renovo royalties on sales of JUVISTA and milestone payments of up to US$525 million on the achievement of very significant sales targets.
 
 
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
 
 
Registered in England 2883758  Registered Office as above
 

 
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 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 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 and 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 date of INTUNIV™ (guanfacine) extended release (ADHD); Shire’s ability to secure new products for commercialization and/or development; Shire’s ability to benefit from its acquisition of New River Pharmaceuticals Inc.; the successful development of JUVISTA® (human TGFβ3) 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, 2006.
 
 
Registered in England 2883758  Registered Office as above
 
 
 

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-----END PRIVACY-ENHANCED MESSAGE-----