-----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, OSO7MqoLX29dK9jVO2KnjahYZaxcQKbElh6Oxh8lcZrDorEnpLTzvG5UDx61uEuE UwU1Cym7NX1mzO9oyurJOg== 0000950103-06-002399.txt : 20061020 0000950103-06-002399.hdr.sgml : 20061020 20061020131732 ACCESSION NUMBER: 0000950103-06-002399 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20061018 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061020 DATE AS OF CHANGE: 20061020 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: 061155036 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 dp03764_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):  October 18, 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 and Exhibit 99.02 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 October 18, 2006
99.02   Press Release dated October 19, 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 19, 2006






EXHIBIT INDEX


Number Description
   
99.01 Press Release dated October 18, 2006
99.02 Press Release dated October 19, 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  
     

18 October 2006

Shire plc ("Shire")

Purchase of Shares by Employee Benefit Trust

Shire has been notified that on 17 October 2006, the Shire plc Employee Benefit Trust (the “Trust”) purchased 200,000 Ordinary Shares of Shire plc (“Shares”) at an average price of 946.3186 pence per Share. This purchase was made pursuant to the Trustee’s irrevocable, non-discretionary programme to purchase Shares during the period commencing 02 October 2006 and ending on 23 February 2007.

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  
     

ELAPRASE™ (idursulfase) receives positive opinion in Europe

First therapy for Hunter syndrome patients on target for launch early in 2007

Basingstoke, UK and Philadelphia, US – 19 October 2006 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) today reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of ELAPRASE for the long-term treatment of patients with Hunter syndrome (Mucopolysaccharidosis II). The EU Marketing Authorisation is expected early in 2007 and will result in unified labelling that will be valid in the current EU 25 member states as well as in Iceland and Norway.

Hunter syndrome is a very rare, life threatening genetic condition that affects mostly males and results from the absence or deficiency of the lysosomal enzyme iduronate-2-sulfatase. Without this enzyme, cellular waste products accumulate in tissues and organs, which then begin to malfunction. Life expectancy for people with the severe form of the disease is commonly 10 to 20 years.

ELAPRASE was approved earlier this year in the USA by the Food & Drug Administration (FDA) and early access has been granted to patients with Hunter syndrome in a number of European countries including Italy, Germany, Spain, France, Sweden, Denmark and Norway. Demand from patients’ families and healthcare providers has been high and as of the 19th October 2006, 58 patients have already been infused with the treatment in these countries.

The product, which is delivered via weekly infusions, replaces the missing enzyme that Hunter syndrome patients fail to produce in sufficient quantities. The data supporting the licence application have come from the single largest, longest and most comprehensive pivotal (Phase II/III) study of any lysosomal storage disease (LSD) to date.

"The CHMP recommendation is a positive step towards the approval of the use of idursulfase in Europe”, said Dr Ed Wraith, Consultant Paediatrician at Manchester Children’s Hospital and a specialist in Mucopolysaccharidosis (MPS) disorders. “When

Registered in England 2883758 Registered Office as above






licensed, this therapy will provide physicians with the first and only treatment for Hunter syndrome since it was first recognised over 100 years ago.”

- ends -

About ELAPRASE
ELAPRASE is a purified form of the lysosomal enzyme iduronate-2-sulfatase and is produced by recombinant DNA technology in a human cell line.

About Hunter Outcome Survey
Shire is actively tracking health data among individuals affected by Hunter syndrome as part of the company’s long-term outcome survey, called the Hunter Outcome Survey (HOS). HOS is designed to support the gathering, analysis, reporting and sharing of data from around the world about Hunter syndrome. Shire believes that the inclusion of all people affected by Hunter syndrome and the analysis and dissemination of this information will allow for further understanding of Hunter syndrome and disease education on a global scale.

About Hunter Syndrome
Hunter syndrome (MPS II) is a serious genetic disorder mainly affecting males. People with this condition are lacking an enzyme (iduronate sulfatase), which breaks down mucopolysaccharides (long chains of sugar molecule used in the building of connective tissues in the body), also known as glycosaminoglycans or GAG. The incompletely broken down GAG remains in cells throughout the body causing progressive damage.

Babies may show little sign of the disease but, as more and more cells become damaged, symptoms start to appear. Physical manifestations for some people with Hunter syndrome may include distinct facial features, a large head and an enlarged abdomen. People with Hunter syndrome may also experience hearing loss, thickening of the heart valves leading to a decline in cardiac function, obstructive airway disease, sleep apnoea, and enlargement of the liver and spleen. In some cases, central nervous system involvement leads to progressive neurological decline. Life expectancy for people with the severe form of this syndrome is commonly 10 to 20 years.

Shire estimates that there are approximately 2,000 patients worldwide afflicted with Hunter Syndrome in countries where reimbursement may be possible.

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

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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