-----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, DakAP6SNTu8a0V2NWjtcHDGLij1MEnMz9vn/+R6uxgB75BkTgNKSahaoXZyPg4c1 gzmDz4IT0OJ9pOQhrTscSQ== 0000950162-02-001395.txt : 20021018 0000950162-02-001395.hdr.sgml : 20021018 20021018125507 ACCESSION NUMBER: 0000950162-02-001395 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20021015 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20021018 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: 02792381 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 shire8k101802.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): October 15, 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 October 15 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: October 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 October 18, 2002 EX-99.1 3 shire8kex101802.txt PRESS RELEASE [COMPANY'S LOGO] 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 18/10/2002 7:00 am EST 12:00noon BST SHIRE ACQUIRES A NEW PROJECT FOR ULCERATIVE COLITIS Basingstoke, UK - 15 October 2002 - Shire Pharmaceuticals Group plc (LSE: SHPL, NASDAQ: SHPGY, TSX: SHQ) announces that it has in-licensed rights to another mesalazine project; a single dose 2g and 4g 5-ASA rectal foam for the treatment of ulcerative colitis. The agreement with Giuliani S.p.A. gives Shire the rights to develop, manufacture and market this foam treatment worldwide (excluding Italy, Vatican State and San Marino) with a patent for the United States. The rectally administered foam is considered more acceptable and easier to use than conventional liquid enema treatments for many patients. The acceptability of this type of therapy for patients is a major factor in compliance with treatment regimens and ultimate clinical success. The foam is already marketed in Italy* however, Shire will focus its development of the project for the US market. Shire's acquisition gives it a strong portfolio of GI products in the US with Pentasa and SPD476, positioning the company well in the $500m ulcerative colitis market sector. Shire will conduct phase III clinical studies using the rectal foam with the objective of submitting for a US NDA (new drug application) upon completion of the clinical program. The project will be known as SPD480. Dr Wilson Totten, Group R&D Director, of Shire, said: "This new project has the potential to provide patients with an effective and convenient treatment for this painful and serious condition. With this acquisition, Shire strengthens further its position in the gastroenterology specialist field, where the company currently markets two products, PENTASA(TM) in the US and COLAZIDE** in Europe*** and now has two GI projects in development." -ends- 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 7938 Michele Roy - Media +1 450 978 7938 Notes to editors *branded ASACOL in Italy **COLAZIDE is a trademark of Salix Pharmaceuticals ***COLAZIDE is currently marketed in the UK by Shire and in Sweden and Denmark by distributors Notes on ulcerative colitis and 5-ASA Ulcerative colitis is a serious chronic inflammatory disease of the colon and rectum, with an average worldwide incidence of 6-15 new cases/100,000/year and a prevalence of 15 times that number. The major clinical features are diarrhoea, muco-hematic secretions, abdominal pain, urgency and sense of incomplete evacuation. The characteristic course is one of remissions and exacerbations over a number of years. Morbidity can be long lasting and can be associated with various extra-intestinal and late complications. 5-ASA (mesalazine or mesalamine) has been known to be effective in the treatment of ulcerative colitis for several decades due to its anti-inflammatory properties. However, the mechanism of action of 5-ASA is poorly understood. To exert its therapeutic effect, 5-ASA must be delivered to the colon, either directly via the rectal route or indirectly via the oral route, where it appears to act locally on the inflamed colonic mucosa. 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, oncology and anti-infectives. 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, including but not limited to the impact of same on Shire's ADHD franchise of which estimated forecast are speculative and should be read accordingly, patents, government regulation and approval, including but not limited to the expected product approval date of lanthanum carbonate (FOSRENOL/FOZNOL), 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-----