CAT reports HUMIRA approval

Cambridge Antibody Tech Group PLC 02 January 2003 03/CAT/01 FOR IMMEDIATE RELEASE 12.00 GMT 07.00 EST 2 January 2003 For further information contact: Cambridge Antibody Technology Tel: +44 (0) 1223 471 471 Weber Shandwick Square Mile (Europe) Peter Chambre, Chief Executive Officer Tel: +44 (0) 20 7067 0700 John Aston, Chief Financial Officer Kevin Smith Rowena Gardner, Director of Corporate Cass Helstrip Communications BMC Communications/The Trout Group (USA) Tel: 001 212 477 9007 Brad Miles, ext 17 (media) Brandon Lewis, ext.15 (investors) CAMBRIDGE ANTIBODY TECHNOLOGY REPORTS HUMIRA APPROVAL Cambridge, UK... Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) today acknowledges the announcement by Abbott Laboratories that it has received US Food and Drug Administration (FDA) approval to market HUMIRATM (adalimumab, previously known as D2E7) for the treatment of rheumatoid arthritis (RA), earlier than anticipated. In an announcement dated 31 December 2002, Abbott Laboratories reported that HUMIRA is the first human monoclonal antibody approved for reducing the signs and symptoms and inhibiting the progression of structural damage in adults with moderately to severely active RA who have had insufficient response to one or more traditional disease modifying antirheumatic drugs (DMARDs). Abbott Laboratories also stated that HUMIRA will offer convenient every other week dosing by subcutaneous injection (shot beneath the skin). A specially designed prefilled syringe for RA patients whose hands may be affected by crippling joint destruction will be available in pharmacies next month. Abbott is confident it can supply sufficient quantities to meet patient demand and recently announced a manufacturing expansion to meet future demand for HUMIRA. The FDA's approval of HUMIRA comes only nine months after simultaneous regulatory submissions in the United States and Europe. HUMIRA was discovered through a broad scientific collaboration between CAT and Abbott. As part of the collaboration, Abbott had the right to select several target antigens for which a joint CAT/Abbott research team would discover human antibody therapeutics. HUMIRA was isolated and optimised by Abbott and CAT as part of this collaboration. Abbott owns exclusive worldwide rights to HUMIRA, including responsibility for clinical development, manufacturing, sales and marketing. Abbott will book all revenues for HUMIRA, and CAT will receive a royalty fee based on HUMIRA sales. The European Agency for the Evaluation of Medicinal Products (EMEA) accepted Abbott's submission for HUMIRA for the treatment of RA in April 2002, and Abbott anticipates approval in mid-2003. -ENDS- Notes to Editors Cambridge Antibody Technology (CAT): CAT is a UK-based biotechnology company using its proprietary technologies and capabilities in human monoclonal antibodies for drug discovery and drug development. Based near Cambridge, England, CAT currently employs around 290 people. CAT is a leader in the discovery and development of human therapeutic antibodies and has an advanced proprietary platform technology for rapidly isolating human monoclonal antibodies using phage display systems. CAT has extensive phage antibody libraries, currently incorporating more than 100 billion distinct antibodies. These libraries form the basis for the Company's strategy to develop a portfolio of antibody-based drugs. HumiraTM is the leading CAT-derived antibody. Six other CAT-derived human therapeutic antibodies are at various stages of clinical trials. CAT has alliances with a large number of pharmaceutical and biotechnology companies to discover, develop and commercialise human monoclonal antibody-based products. CAT has also licensed its proprietary human phage antibody libraries to several companies for target validation and drug discovery. CAT's collaborators include: Abbott, Amgen, Amrad, Chugai, Elan, Genzyme, Human Genome Sciences, Merck & Co, Pharmacia and Wyeth Research. CAT is listed on the London Stock Exchange and on NASDAQ since June 2001. CAT raised £41m in its IPO in March 1997 and £93m in a secondary offering in March 2000. Application of the Safe Harbor of the Private Securities Litigation Reform Act of 1995: This press release contains statements about Cambridge Antibody Technology Group plc ("CAT") that are forward looking statements. All statements other than statements of historical facts included in this press release may be forward looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934. These forward looking statements are based on numerous assumptions regarding CAT's present and future business strategies and the environment in which CAT will operate in the future. Certain factors that could cause CAT's actual results, performance or achievements to differ materially from those in the forward looking statements include: market conditions, CAT's ability to enter into and maintain collaborative arrangements, success of product candidates in clinical trials, regulatory developments and competition. This information is provided by RNS The company news service from the London Stock Exchange
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