-----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, VX9NL7AM/rOcUnvfaD1//7ieZBYOYW+/WzdoZyjN/Y9ItcqwwoFnQTppfQbAJxWP 1Oesne6NM3Hktro4Nlvhqg== 0000950162-02-001253.txt : 20020918 0000950162-02-001253.hdr.sgml : 20020918 20020918143612 ACCESSION NUMBER: 0000950162-02-001253 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20020916 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20020918 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: 02766799 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 shire8k091702.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): September 16, 2002 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 September 16, 2002 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: September 18, 2002 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 September 16, 2002 EX-99.1 3 shire8k091702press.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 For immediate release FOSRENOL(TM) update Basingstoke, UK - 16th September 2002 - Shire Pharmaceuticals Group plc (LSE: SHP.L, NASDAQ: SHPGY, TSX: SHQ CN) announces an update on FOSRENOL. Shire is in continuing discussions with the EU reference member state with whom it has filed its application to approve FOSRENOL, a phosphate binder treatment for end stage renal disease patients. As part of the approval process Shire is in regular contact with the reference member state reviewing the substantial data set submitted. Shire has just been informed that the process of addressing the remaining issues, including external expert review, will not complete before the end of Q3 as previously indicated by the company. While Shire is confident that all outstanding questions can be answered over the coming few months, it is increasingly likely that first approval will not now be granted during 2002. Further meetings to deal with the outstanding questions are planned with the reviewing authority, and updates will be provided in due course. Shire continues to plan for a European launch for FOSRENOL during 2003, subject to regulatory approval. For further information please contact: Global (outside US and Canada) Clea Rosenfeld - Investor Relations +44 1256 894 160 Jessica Mann - Media +44 1256 894 280 US & Canada Gordon Ngan - Investor Relations +1 450 978 7942 Michele Roy - Media +1 450 978 7938 Notes to editors Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc (Shire) is a rapidly growing international specialty pharmaceutical company with a strategic focus on three therapeutic areas - central nervous system disorders (CNS), oncology and anti-infectives. Shire also has two platform technologies: advanced drug delivery and biologics. Shire's core strategy is based on research and development combined with in licensing and a focus on eight key pharmaceutical markets. For further information on Shire, please visit the Company's website: www.shire.com THE "SAFE HARBOUR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. The statements in this press release 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 that 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 and commercialisation, the impact of competitive products, patents, government regulation and approval, and other risks and uncertainties detailed from time to time in periodic reports produced by Shire, including the Annual Report filed on Form 10K by Shire with the Securities and Exchange Commission. -----END PRIVACY-ENHANCED MESSAGE-----