-----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, SjWc4rsrTQ4WNm/6SznYqVKGt0OJnGvjwdKwuJ+xpkc44RWl3RkSNnV23A29zT64 Bg3ssWKYVaA/g1sn4o0Utw== 0000950103-07-000710.txt : 20070321 0000950103-07-000710.hdr.sgml : 20070321 20070321152503 ACCESSION NUMBER: 0000950103-07-000710 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070321 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070321 DATE AS OF CHANGE: 20070321 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: 07709063 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 dp05100e_8k.htm Unassociated Document
 
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 21, 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.f13e-4(c))
 
 
 

 
 
Item 8.01. Other Events
 
Shire plc has issued the press release attached 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 March 21, 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: March 21, 2007
 
 
 

 
 
EXHIBIT INDEX
 
Number
Description
99.01
Press Release dated March 21, 2007
   
 
 

 
EX-99.1 2 ex9901e.htm Unassociated Document
 
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
 
 
ADDERALL XR® - Shire Files Suit against Colony Pharmaceuticals, Inc., Actavis, Inc. and Actavis Group hf
 
Basingstoke, UK and Philadelphia, US - March 21, 2007 - Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the District of Maryland against Colony Pharmaceuticals, Inc., Actavis, Inc., and Actavis Group hf (collectively “Colony”) for infringement of Shire’s U.S. Patent Nos. 6,322,819, 6,605,300 and 6,913,768.

The lawsuit results from an ANDA (Abbreviated New Drug Application) filed by Colony for generic versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALL XR®, pursuant to which Colony provided notice in November 2004 that it would seek to market its generic products before the expiration of Shire’s patents. The lawsuit alleges that all of Colony’s generic strengths infringe the three patents in suit.

Adderall XR® is Shire’s Attention Deficit Hyperactivity Disorder (“ADHD”) medicine.
 
 
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

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

Registered in England 2883758 Registered Office as above
 

 
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 dates of SPD503 (guanfacine extended release) (ADHD) and SPD465 (extended release triple-bead mixed amphetamine salts) (ADHD); Shire's ability to secure new products for commercialization and/or development; Shire’s planned acquisition of New River Pharmaceuticals announced February 20, 2007; and other risks and uncertainties detailed from time to time in Shire's and its predecessor registrant Shire Pharmaceuticals Group 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, 2005.
 
Registered in England 2883758 Registered Office as above
 

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