-----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, Wy1SfrlMSGC8dQMgUOrdSMOKD+b3JktVqTx5VQbBfehwcZFllSbr6W0zf++5a07k G8H0STT6U1MPqDkNFjedkQ== 0000950162-03-001039.txt : 20030725 0000950162-03-001039.hdr.sgml : 20030725 20030725111835 ACCESSION NUMBER: 0000950162-03-001039 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030725 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030725 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SHIRE PHARMACEUTICALS GROUP 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: 03802438 BUSINESS ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 BUSINESS PHONE: 1264333455 MAIL ADDRESS: STREET 1: HAMPSHIRE INTL BUSINESS PARK STREET 2: CHINEHAM BASINGSTOKE CITY: HAMPSHIRE ENGLAND RG STATE: X0 8-K 1 shire8k072503.txt FORM 8-K 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): July 25, 2003 Shire Pharmaceuticals Group plc ________________________________________________________________________________ (Exact name of registrant as specified in its charter) England and Wales ________________________________________________________________________________ (State or other jurisdiction of incorporation) 0-29630 98-0359573 (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) Item 5. Other Events Shire Pharmaceuticals Group plc has issued the press release attached as Exhibit 99.1 and incorporated by reference herein. Item 7. Financial Statements and Exhibits (c) Exhibits. The following exhibit is filed herewith: 99.1 Press Release dated July 25, 2003 -2- 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. Dated: July 25, 2003 SHIRE PHARMACEUTICALS GROUP PLC By: /s/ Angus Charles Russell ------------------------------- Name: Angus Charles Russell Title: Group Finance Director EXHIBIT INDEX Number Description 99.1 Press Release dated July 25, 2003 EX-99.1 3 shire8k072503ex.txt PRESS RELEASE Shire Pharmaceuticals Group plc Hampshire International Business Park, Chineham, Basingstoke RG24 8EP UK Tel +44 1256 894000 Fax +44 1256 894708 http://www.shire.com Shire XAGRID(TM) (anagrelide hydrochloride) receives a positive opinion from the European Committee for Proprietary Medicinal Products (CPMP) Basingstoke, UK - 25 July, 2003- Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that it has received a positive opinion from the CPMP for XAGRID(TM) (anagrelide hydrochloride) capsules to be used in the treatment of essential thrombocythaemia (ET). The CPMP is the scientific committee of the European Medicines Evaluation Agency (EMEA), and the CPMP opinion will be ratified by the European Commission as part of the granting of the pan-European marketing authorisation. Following the marketing approval, pricing reimbursement negotiations will commence with individual national authorities prior to launch. XAGRID was granted European orphan drug status on 29 December 2000 for the treatment of ET, thereby providing the product with up to ten years market exclusivity in Europe from the date of marketing authorisation approval. Essential thrombocythaemia is a chronic disorder of bone marrow, which is associated with the increased production of blood platelets. Excessive platelet production can result in abnormal blood clot formation and bleeding, thereby increasing the risk of stroke, heart attack and gastrointestinal bleeding. It is estimated by Shire that 40,000 patients suffering from ET across the European Union member states would be eligible for treatment with XAGRID. There is currently no other platelet-reducing treatment approved for the treatment of ET across the whole EU. The drug is already marketed by Shire in the US and a range of other territories under the trademark AGRYLINTM. Sales of AGRYLIN in 2002 were $119.2 million, up 39% on 2001. Says Dr Wilson Totten, Shire's Group R&D Director: "XAGRID is a unique medicine for patients suffering from essential thrombocythaemia as other currently marketed treatments can cause serious side-effects by decreasing white or red blood cell counts. XAGRID is platelet selective, targeting only those cells that develop into platelets. We welcome the CPMP's opinion that XAGRID can have a beneficial role in helping these patients across Europe." 1 For further information please contact: Global (outside US and Canada) Clea Rosenfeld - Investor Relations +44 1256 894 221 Jessica Mann - Media +44 1256 894 280 US & Canada Gordon Ngan - Investor Relations +44 1256 894 160 Michele Roy - Media +1 450 978 7876 Notes to editors o Shire acquired the worldwide rights to XAGRID/AGRYLIN from Bristol-Myers Squibb in June 1999. o The EMEA procedure included 15 European Communities countries, plus Iceland and Norway. o Orphan drug status for XAGRID has also been designated by the Japanese Authorities, giving ten years' market exclusivity upon approval. The product is currently in phase I trials in Japan Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc (Shire) is a rapidly growing international emerging pharmaceutical company with a strategic focus on four therapeutic areas - - central nervous system disorders (CNS), gastrointestinal (GI), oncology, and anti-infectives. Shire also has three platform technologies: advanced drug delivery, lead optimisation for small molecules and Biologics. Shire's core strategy is based on research and development combined with in-licensing and a focus on key pharmaceutical markets. For further information on Shire, please visit the Company's website: www.shire.com THE "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 materialise, 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 commercialisation, the impact of competitive products, including, but not limited to, the impact on Shire's Attention Deficit 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 lanthanum carbonate (FOSRENOL(R)) and METHYPATCH(R), and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K by Shire with the Securities and Exchange Commission. 2 -----END PRIVACY-ENHANCED MESSAGE-----