-----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, BqYywKMaDdn8o8XtLCh7mW0CRYJpkuuydG1MRObhdafbbctRAjCMaVGPhhh2ifAS uHvMbWq0vGH1gZc5r4fzyA== 0000950162-03-000065.txt : 20030114 0000950162-03-000065.hdr.sgml : 20030114 20030109162937 ACCESSION NUMBER: 0000950162-03-000065 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030109 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030109 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: 03509377 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 shire8k010903press.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): January 9, 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) -2- 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 January 9, 2003 -3- 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: January 9, 2003 SHIRE PHARMACEUTICALS GROUP PLC By: /s/ Angus Russell ---------------------------------------- Name: Angus Russell Title: Group Finance Director EXHIBIT INDEX Number Description 99.1 Press Release dated January 9, 2003 EX-99.1 3 shire8kpressex010903.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 Response to ANDA application on FDA website for a generic copy of ADDERALL XR(TM) Basingstoke, UK- 9 January 2003 - Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) notes that the FDA has featured an ANDA (abbreviated new drug application) application for a copy of Adderall XR(TM) on its website and although this information has not been confirmed, Shire makes the following comments: o ADDERALL XR is protected by a granted pharmaceutical composition patent that extends to 2018. o If any ANDA applicant company wishes to launch such a product prior to the expiry of the ADDERALL XR patent, it will have to provide Shire with a notice alleging that Shire's patent is invalid and/or not infringed and provide a factual and legal basis for this allegation. This must be notified to Shire giving the company the opportunity to commence infringement litigation. No such notification has been received. o Shire will exercise its policy of vigorously defending its patent rights. The ANDA cannot be approved if litigation is in process. Such litigation typically may take up to 30 months which would extend the earliest date for any launch to mid 2005. o In addition, ADDERALL XR has Hatch-Waxman exclusivity which prevents approval of a generic copy until October 2004 at the earliest, irrespective of the patent status. o On 18th December 2002, Shire submitted an sNDA for adult indication for ADDERALL XR. Says Shire Chief Executive, Rolf Stahel: "Shire has a carefully planned future ADHD strategy. ADDERALL XR is in a strong position with a granted composition patent that lasts until 2018 as well as data protections giving exclusivity until the fourth quarter of 2004. We believe that it will be difficult for a generic company to develop a product that is similar enough to ADDERALL XR to receive FDA approval with an AB rating, allowing substitution by the pharmacist in the US and at the same time replicating the full patient benefits of ADDERALL XR. We intend of course to rigorously defend our intellectual property rights." Ends For further information please contact: Global (outside US & 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 Shire Pharmaceuticals Group plc Shire Pharmaceuticals Group plc (Shire) is a rapidly growing international specialty pharmaceutical company with a strategic focus on four therapeutic areas - central nervous system disorders (CNS), oncology, gastro-intestinal (GI) 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 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 made 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, including but not limited to the impact of same on Shire's ADHD franchise of patents, government regulation and approval, including but not limited to the expected approval date of lanthanum carbonate (FOSRENOL/FOSNOL) 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-----