-----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, TFRI+GBHKoOqnD8bPyM0OZYAXpuCb8O8qJ1rURWpOHZt6KgMLM5UjfFSJuZMBXDg ezxdzTm1BUgA4Xa7A1hseg== 0000950103-05-002437.txt : 20051201 0000950103-05-002437.hdr.sgml : 20051201 20051201140636 ACCESSION NUMBER: 0000950103-05-002437 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20051201 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051201 DATE AS OF CHANGE: 20051201 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: 051237133 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 dec0105_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):  December 1, 2005

Shire plc

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

(State or other jurisdiction of incorporation)

0-29630   None
(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 December 1, 2005
99.02 Press Release dated December 1, 2005





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: December 1, 2005

 




EXHIBIT INDEX

Number Description
99.01 Press Release dated December 1, 2005
99.02 Press Release dated December 1, 2005





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  
   

Stock Exchange Announcement

1 December 2005

Shire plc (the “Company”)

The Company announces that on 1 December 2005 it was notified of the acquisition in London, on that day, of ordinary shares in the Company by a Director, and an acquisition by a Person Discharging Managerial Responsibilities, following exercises of options held under the Shire plc Sharesave Scheme. The exercise price was £5.02.

Notification of the acquisition of shares by a Director

1,882 ordinary shares of 5p each in the Company were acquired by Mr Angus Russell, Chief Financial Officer, being 0.0004% of the issued shares of that class. As a result of this transaction, Mr Russell has a total interest of 1,882 ordinary shares in the Company.

Notification of the acquisition of shares by a Person Discharging Managerial Responsibilities

1882 ordinary shares of 5p each in the Company were acquired by Ms Tatjana May, General Counsel, Company Secretary and Executive Vice President Global Legal Affairs, being 0.0004% of the issued shares of that class. As a result of this transaction, Ms May has a total interest of 2,606 ordinary shares in the Company being 0.0005% of the issued shares of that class.

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

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

Registered in England 2883758 Registered Office as above






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

 




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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 files idursulfase with EMEA for
treatment of Hunter syndrome

Basingstoke, UK and Philadelphia, PA, US,– December 1, 2005 -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for idursulfase for the treatment of Hunter syndrome. Review of a MAA by EMEA typically takes 12 months. If approved, this would be the first human enzyme replacement therapy for the treatment of Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II).

“Following last week’s filing in the United States, our MAA filing with the EMEA is another key milestone in bringing to market a treatment for patients and families around the world living with Hunter syndrome,” said Dr. David D. Pendergast, executive vice president and general manager of Shire Human Genetic Therapies, the Shire specialty unit focused specifically on genetic diseases. “I look forward to approval and subsequent launch in Europe in late 2006 or early 2007.”

As previously announced, Shire filed idursulfase under the tradename ELAPRASETM with the U.S. Food and Drug Administration (FDA) on November 23, 2005 under a Fast Track designation and has requested Priority Review of that submission, which would result in a six-month FDA review.

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

About Hunter Syndrome and idursulfase

Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II), is a rare, life threatening, genetic disorder with no available treatment. Individuals with Hunter syndrome lack the enzyme iduronate-2-sulfatase, which is essential in the continuous process of replacing and breaking down glycosaminoglycans (GAG). As a result, GAG remains stored in cells in the body causing progressive






damage. The symptoms of Hunter syndrome are usually not visible at birth, but usually start to become noticeable after the first or second year of life. Often the first symptoms may include hernias, frequent ear infections, runny noses, reduced growth rate and abnormal facial appearance. As the disease progresses, a variety of symptoms appear including enlarged liver and spleen, heart failure, decreased endurance, obstructive and restrictive airway disease, sleep apnea, joint stiffness, and, in some cases, central nervous system involvement. If central nervous system involvement exists, the life expectancy for patients with Hunter syndrome is typically 10-15 years of age, however, some patients can survive into the fifth or sixth decade of life. There is currently no effective therapy for Hunter syndrome.

Idursulfase is a human iduronate-2-sulfatase produced by genetic engineering technology, developed to replace the missing enzyme in Hunter syndrome patients. Idursulfase has been designated an orphan drug in both the United States and in the European Union.

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

Shire is committed to helping patients and families with Hunter syndrome. Further information about Hunter syndrome is available at http://www.hunterpatients.com.

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 DAYTRANATM (MTS/METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476) (ulcerative colitis), ELAPRASE TM (idursulfase) (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 Pharmaceuticals Group plc's Annual Report on Form 10-K for the year ended December 31, 2004.






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