-----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, IZzbM0IUq2Noq84TyIF6FHGAcbnqkWLh/zOpSWX1eVcg48poQjMA4EgUu5oenBDB Ud5fP/JltYShUwuy/fzDZQ== 0000950162-03-000333.txt : 20030227 0000950162-03-000333.hdr.sgml : 20030227 20030227155839 ACCESSION NUMBER: 0000950162-03-000333 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030227 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20030227 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: 03583532 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 shire8kno1022703.txt FORM 8K 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): February 27, 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 February 27, 2003 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: February 27, 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 February 27, 2003 EX-99.1 3 shire8kno1ex991022703.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 12 noon GMT 7am ET SHIRE BOOSTS ADHD PORTFOLIO WITH ACQUISITION BASINGSTOKE, UK - 27 FEBRUARY 2003 - Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that it has agreed to acquire from Noven Pharmaceuticals, Inc. the worldwide sales and marketing rights to METHYPATCH(R)*, a methylphenidate transdermal delivery system for the once daily treatment of ADHD (attention deficit and hyperactivity disorder) which was filed on 27 June 2002 with the US FDA (Food & Drug Administration). Shire will make an upfront payment to Noven of $25 million followed by separate milestone payments up to $125 million, which will be dependent on FDA approval and the achievement of certain sales targets. All payments will be made in cash. The transaction is expected to be modestly dilutive for the first 18 months and is expected to be accretive thereafter. The acquisition is in line with Shire's strategy of maintaining leadership in the US ADHD market. Shire's current lead product for ADHD, Adderall XR(R), is a successful new once daily formulation of mixed amphetamine salts, enhancing the long-established Adderall(R) brand. The acquisition of the METHYPATCH will enable Shire to develop a significant new presence in the methylphenidate segment of the market which currently represents 53% of the US ADHD prescription volume**. Subject to regulatory approval on the transaction and the NDA application submitted by Noven, Shire anticipates a US launch for the product in the second half of 2003. Shire will make use of its existing US sales force to sell the new product. Noven will provide manufacturing. Shire will be responsible for post launch phase-IV trials and will have full international rights to all future METHYPATCH improvements. METHYPATCH has a technology patent until 2012 and composition patents in the US until September 2018 and other key markets until December 2018. Says Shire Chief Executive, Rolf Stahel: "This is an acquisition that is core to Shire's strategy. METHYPATCH(R)* strengthens our position as the leading ADHD company. Over the last twelve months Adderall XR(R), taken once a day orally, has become the fastest growing product in the ADHD market, reflecting the positive response to Adderall XR from doctors and patients alike. METHYPATCH will be the first transdermal drug delivery based product offered to doctors and patients for the treatment of ADHD. METHYPATCH provides flexibility as patients can now control the duration of medication effect by adjusting the wear time of the product. The addition of METHYPATCH to the Shire portfolio will enable us to more completely serve the needs of ADHD patients." Says Noven President, CEO and Chairman, Robert Strauss: "We are very pleased with the appointment of Shire as our strategic development and marketing partner for METHYPATCH(R)*. Shire is clearly the leader in ADHD. They have demonstrated their strong capabilities through the very successful development and launch of Adderall XR(R). Shire's global development and marketing ability was another key factor in our decision to select Shire. We are very proud that our product will lead Shire's expansion into the market for long-acting methylphenidate products, and view this transaction as the first step towards a long and successful relationship with the world leader in ADHD therapy." FOR FURTHER INFORMATION PLEASE CONTACT: GLOBAL (OUTSIDE US AND CANADA) Gordon Ngan - Investor Relations +44 1256 894 160 Jessica Mann - Media +44 1256 894 280 US & CANADA Michele Roy - Media +1 450 978 7876 NOVEN CONTACT: Joseph C. Jones Vice President, Corporate Affairs Noven Pharmaceuticals, Inc. 11960 SW 144th Street Miami, Florida 33186 Phone: 305-964-3101 Fax: 305-232-1836 E-mail: jjones@noven.com NOTES TO EDITORS * registered trademark of Noven Pharmaceuticals, Inc. ** source IMS monthly data January 2003 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 2 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(TM)) 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. ABOUT NOVEN Noven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leading developer of advanced transdermal drug delivery technologies and prescription transdermal products. Noven's existing products include advanced estrogen transdermal delivery systems and combination estrogen/progestin transdermal delivery systems. With a range of additional products in development, including MethyPatch(R), Noven is committed to becoming the world's premier developer, manufacturer and marketer of transdermal drug delivery systems. For additional information on Noven and its licensing opportunities, visit www.noven.com 3 -----END PRIVACY-ENHANCED MESSAGE-----