-----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, WbiroiLd2JydXvw0xM7TJShAlsNGbWFIKrZ9G1/GvnVTP4jKpvXcVpNntGXVEieR cTXCFbZVoFdhjC+tdNZvnA== 0000950103-08-000335.txt : 20080213 0000950103-08-000335.hdr.sgml : 20080213 20080213090400 ACCESSION NUMBER: 0000950103-08-000335 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20080212 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080213 DATE AS OF CHANGE: 20080213 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: 08601059 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 dp08621_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): February 12, 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.):

[  ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

[  ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

[  ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

[  ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.f13e-4(c))



 

 
Item 8.01.  Other Events

     Shire plc has issued the press releases attached hereto as Exhibit 99.01, Exhibit 99.02 and Exhibit 99.03 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 February 12, 2008
99.02                    Press Release dated February 12, 2008
99.03                    Press Release dated February 13, 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: February 13, 2008
 
 

 
 
EXHIBIT INDEX
 
Number
Description
 
99.01
99.02
99.03
Press Release dated February 12, 2008
Press Release dated February 12, 2008
Press Release dated February 13, 2008
   
 
 
EX-99.01 2 dp08621_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
 


Full Year 2007 results date notification – 21 February 2008

 
Basingstoke, UK and Philadelphia, US – 12 February 2008– Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, will announce full year 2007 earnings on Thursday 21 February 2008.

Results press release will be issued at:
12:00 GMT / 07:00 EST
Investor meeting and conference call time:
14:00 GMT / 09:00 EST

Investor & Analyst meeting and conference call:
Matthew Emmens, Chief Executive Officer, Angus Russell, Chief Financial Officer, Mike Cola, President, Specialty Pharmaceuticals and Sylvie Grégoire, President, Human Genetic Therapies will host the investor and analyst meeting and conference call at 14:00 GMT/9:00 EST.

The meeting will take place at the offices of Deutsche Bank, Winchester House, 1 Great Winchester Street, London, EC2N 2DB.

Please email ssalah@shire.com to register to attend this meeting in London.

The details of the conference call are as follows:

UK dial in:
0800 953 0934
US dial in:
1866 224 2843
International dial in:
+44 (0) 1452 569 102
Password/Conf ID:
34394878
Live Webcast:*
http://gaia.world-television.com/shire/20080221

Replay:
A replay of the presentation will be available for two weeks by phone and by webcast for one year.  Details are as follows:

UK dial in
0800 953 1533
US dial in
1866 247 4222
 
 

 

 
International dial in
+44 (0) 1452 55 00 00
Pin code
34394878 #
Webcast replay:*
http://gaia.world-television.com/shire/20080221

* Email verification is required

 
For further information please contact:

Investor Relations
Souheil Salah
+44 1256 894 160

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 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.
 
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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
 

 
Notification of major interests in shares

Basingstoke, UK and Philadelphia, US – February 12, 2008– Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company,

1. Identity of the issuer or the underlying issuer of existing shares to which voting rights are attached:

Shire plc

2. Reason for the notification
State
Yes/No
An acquisition or disposal of voting rights
 
An acquisition or disposal of financial instruments which may result in the
acquisition of shares already issued to which voting rights are attached
 
An event changing the breakdown of voting rights
Yes
Other (please specify):  
 

3. Full name of person(s) subject to the notification obligation:
Legal & General Group Plc (L&G)
4. Full name of shareholder(s) (if different from 3.):
N/A
5. Date of the transaction (and date on which the threshold is crossed
or reached if different):
N/A
6. Date on which issuer notified:
11 February 2008
7. Threshold(s) that is/are crossed or reached:
Above 5%  (L&G)
8. Notified details:
 


A: Voting rights attached to shares

Class/type of shares
 if possible using the ISIN CODE
Situation previous to
the Triggering
transaction
Resulting situation after the triggering
transaction
 
Number
of
Shares
Number
of
Voting
Rights
Number
of
shares
Number of voting
rights
% of voting
rights
     
Direct
Direct
Indirect
Direct
Indirect
GBP Ord. 0.05
 
Below 5%
29,425,145
26,920,655
2,504,490
4.813
0.447
 
 
 
 
 
 
 
 
ADR Shares
 
 
8,133
21,897
2,502
0.003
0.0004

 
 


 
B: Financial Instruments

Resulting situation after the triggering transaction

Type of financial
instrument
Expiration
date
Exercise/Conversion
Period/ Date
Number of voting
rights that may be
acquired if  the instrument
is exercised/converted
% of voting
rights
 
 
 
 
 


Total (A+B)
 
Number of voting rights
% of voting rights
29,449,544
5.26


9. Chain of controlled undertakings through which the voting rights and/or the financial instruments are effectively held, if applicable:
 
Legal & General Group Plc (Direct and Indirect) (Group)
(29,449,544 – 5.26% = Total Position)
   
Legal & General Investment Management (Holdings) Limited (LGIMH) (Direct and Indirect)
(29,449,544 – 5.26% = Total Position)
   
Legal & General Investment Management Limited (Indirect) (LGIM)
(29,449,544 – 5.26% = Total Position)
 
Legal & General Group Plc (Direct) (L&G) (26,942,552 – 4.81% = LGAS, LGPL & PMC)
   
Legal & General Investment Management (Holdings) Limited
(Direct) (LGIMHD) (21,007,869-3.75% = PMC)
Legal & General Insurance Holdings Limited (Direct) (LGIH)
   
Legal & General Assurance (Pensions Management)
Limited  (PMC) (21,007,869-3.75% = PMC)
Legal & General Assurance Society Limited  (LGAS & LGPL)
   
 
Legal & General Pensions Limited (Direct)  (LGPL)
 
 


 
Proxy Voting:

10. Name of the proxy holder:
N/A
11. Number of voting rights proxy holder will cease to hold:
N/A
12. Date on which proxy holder will cease to hold voting rights:
N/A

13. Additional information:
Notification using the total voting rights figures of 559,283,198
 
14. Contact name:
Helen Lewis (LGIM)
15. Contact telephone number:
020 3124 3851

Contact at Shire plc: Philip Griffin-Smith, Interim Deputy Company Secretary, 01256 894754

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 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.

 
EX-99.03 5 dp08621_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
 


Shire’s ELAPRASE® (idursulfase) Approved in Mexico for Treatment of Hunter Syndrome
Mexico is the First Latin American Country to Approve Treatment

Basingstoke UK and Cambridge MA, US - February 13, 2008– Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ), the global specialty biopharmaceutical company, announced that ELAPRASE® (idursulfase), a human enzyme replacement therapy for the treatment of Hunter syndrome, has been approved for commercial sale by the Mexican Federal Commission for the Protection against Sanitary Risk (COFEPRIS). Mexico is the tenth-largest pharmaceutical market in the world1 and the first Latin American country to approve ELAPRASE.
 
Hunter syndrome, also known as Mucopolysaccharidosis II (MPS II), is a serious, life-threatening genetic condition mainly affecting males that results from an absence of, or deficiency in, the lysosomal enzyme iduronate-2-sulfatase. Without sufficient amounts of this enzyme, cellular waste products accumulate in tissues and organs, which then begin to malfunction, leading to severe clinical complications and early mortality.
 
ELAPRASE, developed by Shire Human Genetic Therapies (HGT), is the first and only enzyme replacement therapy approved for people suffering from Hunter syndrome. The medicine is given as a weekly infusion and is designed to replace the deficient iduronate-2-sulfatase enzyme.
 
The approval of ELAPRASE in Mexico marks a significant milestone because for the first time, Hunter syndrome patients in Mexico have access to treatment,” said Sylvie Grégoire, President of Shire HGT, the Shire business unit focused on genetic diseases. “This approval also underscores our dedication and commitment to provide meaningful treatments for patients suffering from serious and often neglected diseases around the world.”

“Hunter syndrome is a devastating disease and until now, Mexican citizens had no viable treatment,” said Dr. Luis Figuera Villanueva, Title C Investigator, Division of the Genetic Center of Western Biomedical, Investigator of the IMSS and Professor of Human Genetics for the Central University of Heath Sciences, University of Guadalajara. “As a physician, it’s
 
1 Epsicom Business Intelligence. (June 30, 2007) The Pharmaceutical Market: Mexico
 
 
 
 

 
 
 
 
exciting and rewarding to now be able help these patients and their families and offer them hope for a brighter future.”
 
Since its U.S. approval in July 2006, ELAPRASE has been approved for marketing and commercial distribution in 37 countries worldwide including countries in Europe and Japan. Shire expects to launch the product in Mexico within the first half of 2008.
 

 
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
 
Jessica Cotrone (North America)
+1 617 613 4640

Notes to editors
 
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.
 
Shire Human Genetic Therapies 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, whether on therapy or not, and the analysis and dissemination of this information will allow for further understanding of Hunter syndrome and disease education on a global scale.
 
More information about ELAPRASE and Hunter syndrome is available at http://www.elaprase.com or http://www.hunterpatients.com.
 
 
About Hunter Syndrome
 
Hunter syndrome (MPS II) is a serious genetic disorder mainly affecting males that interferes with the body’s ability to break down and recycle waste substances called mucopolysaccharides, also known as glycosaminoglycans or GAG. Hunter syndrome is one of several related lysosomal storage diseases.
 
In Hunter syndrome, cumulative build up of GAG in cells throughout the body interferes with the way certain tissues and organs function, leading to severe clinical complications and early mortality. 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 apnea, and enlargement of the liver and spleen. In some cases, central nervous system involvement leads to progressive neurologic decline.
 
 
 
 

 
 

 
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 the successful development of JUVISTA® (Human TGFb3)), manufacturing and commercialization (including the launch and establishment in the market of VYVANSE™); 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) and GA-GCB (Gene-Activated Glucocerebrosidane); 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.; 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.

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