CATCo Regulatory News (CAT)

5 Oct 2005 15:30

Cambridge Antibody Tech Group PLC05 October 2005 05/CAT/15 FOR IMMEDIATE RELEASE 03.30 BST, 10.30 EST Wednesday 5 October 2005 For Further Information Contact:Cambridge Antibody Technology Weber Shandwick Square Mile (Europe)Tel: +44 (0) 1223 471 471 Tel: +44 (0) 20 7067 0700 Peter Chambre, Chief Executive Officer Kevin SmithJohn Aston, Chief Financial Officer Yvonne Alexander Rowena Gardner, Director of Corporate Communications Rachel Taylor 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 RECENT PROGRESS IN LICENSED PRODUCTCANDIDATES Cambridge, UK - Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) todayacknowledges the announcements this week by Human Genome Sciences, Inc (HGSI)and Abbott Laboratories relating to LymphoStat-B(TM), ABthrax(TM) and HUMIRA(R). LymphoStat-B (belimumab) is a fully human anti-BLyS monoclonal antibody licensedby CAT to HGSI. HGSI is developing LymphoStat-B as a potential treatment forsystemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). In anannouncement dated 5 October 2005, HGSI announced that the results of a Phase IIclinical trial demonstrated that LymphoStat-B was safe, well tolerated, andshowed signs of clinical effect in patients with SLE, although the drug did notmeet the overall primary efficacy endpoints of reducing the signs and symptomsof SLE at Week 24 as measured by SELENA SLEDAI, or increasing the time to firstSLE flare over 52 weeks. LymphoStat-B reduced the signs and symptoms of SLE atWeek 52 at a level of statistical significance in seropositive patients, asubgroup that represented 75% of the studys patient population, as measured byboth SELENA SLEDAI (p=0.021) and the Physicians Global Disease Assessment (p=0.016). Trends to greater reduction in prednisone therapy also were observedacross the active study population. Based on these results, HGSI stated that itnow has a path forward to Phase III for LymphoStat-B in SLE. Further information on LymphoStat-B can be found on the HGSI website:www.hgsi.com. ABthrax is a fully human monoclonal antibody licensed by CAT to HGSI. HGSI isdeveloping ABthrax for use in the treatment of anthrax disease. In anannouncement dated 3 October 2005, HGSI announced that it has been awarded atwo-phase contract to supply ABthrax, a human monoclonal antibody developed foruse in the treatment of anthrax disease, to the US Government. Under the firstphase of the contract, Human Genome Sciences will supply ten grams of ABthrax tothe US Department of Health and Human Services (HHS) for comparative in vitroand in vivo testing. Under the second phase of the contract, under the ProjectBioShield Act of 2004, the US Government has the option to place an order withinone year for up to 100,000 doses of ABthrax for the Strategic NationalStockpile, for use in the treatment of anthrax disease. The HHS comparativetesting results, along with HGSIs own preclinical and clinical study results,will form the basis of the US Governments decision process for exercising itsoption for additional product for the Strategic National Stockpile. Further information on ABthrax can be found on the HGSI website: www.hgsi.com. HUMIRA (adalimumab) is a fully human anti-TNF alpha monoclonal antibody,isolated and optimised by CAT in collaboration with Abbott and now approved formarketing as a treatment for RA. In an announcement dated 4 October 2005, AbbottLaboratories announced it has simultaneously submitted a supplemental BiologicsLicense Application (sBLA) with the US Food and Drug Administration (FDA) and aType II Variation to the European Medicines Agency (EMEA) seeking approval tomarket HUMIRA as a treatment for ankylosing spondylitis, an inflammatory diseaseof the spine and spinal joints. Additionally, on 4 October 2005, Abbott announced that the FDA approved HUMIRAas a first-line treatment of recent onset moderate to severe RA. The EMEAgranted similar approval in August 2005. Further information on HUMIRA can be found on the Abbott website:www.abbott.com. Notes to Editors: Cambridge Antibody Technology (CAT): Business: CAT is a biopharmaceutical company, aiming to bring improvements to seriouslyill patients lives and thereby create outstanding returns for shareholders. CATseeks to develop products independently and in collaboration with partners,using its capabilities and technologies in the discovery and development of newand innovative antibody medicines in selected therapeutic areas. CAT also seeksto licence its technologies to enable others to develop new medicines. CAT has strong financial foundations which arise from its balance sheet strengthand the revenue stream from HUMIRA(R) royalties. The diversified pipeline oflicensed antibody product candidates offers good prospects for growth in themedium term and significant longer term opportunities arise from CATsproprietary development and alliances, especially with Genzyme and AstraZeneca. Products: HUMIRA, licensed to Abbott, is the first CAT-derived antibody to be approved formarketing. It was isolated and optimised in collaboration with Abbott and hasbeen approved for marketing as a treatment for rheumatoid arthritis (RA) in 57countries, and for psoriatic arthritis and early RA in some European countriesand the US. There are six further CAT-derived antibodies licensed to partners at variousstages of clinical development, including ABT-874 (Abbott), LymphoStat-B,HGS-ETR1, HGS-ETR2 (all Human Genome Sciences (HGSI)) and MYO-029 (Wyeth). CAThas also licensed its proprietary technologies and patents to several companies.CATs licensees include Abbott, Amgen, Chugai, Dyax, Genzyme, HGSI, Merck & Co,Micromet, Pfizer and Wyeth, and three antibody drug candidates are in clinicaldevelopment at patent licensees. There is one proprietary CAT human therapeutic antibody product candidates inclinical development, CAT-354, and one in pre-clinical development with Genzyme,GC-1008. Collaborations: CAT has a broad collaboration with Genzyme for the development andcommercialisation of antibodies directed against TGF beta, a family of proteinsassociated with fibrosis and scarring, and with potential application in thetreatment of some cancers. CAT has a major strategic alliance with AstraZeneca to discover and develophuman antibody therapeutics, principally in inflammatory disorders. Thisprovides CAT with the opportunity to build a substantial pipeline of antibodytherapeutics with a significant pharmaceutical partner. CAT has a co-development collaboration with Amrad against GM-CSF Receptor, apotential drug target in the development of RA. Science: CAT has an advanced proprietary technology for rapidly isolating humanmonoclonal antibodies using Phage Display and Ribosome Display systems. CAT hasextensive phage antibody libraries, currently incorporating more than 100billion distinct antibodies, which form the basis for the Companys strategy todevelop a portfolio of antibody-based drugs. Business Background: Based near Cambridge, UK, CAT currently employs around 290 people. CAT is listed on the London Stock Exchange (CAT) and on NASDAQ (CATG). More information can be found at www.cambridgeantibody.com Application of the Safe Harbor of the Private Securities Litigation Reform Actof 1995: This press release contains statements about Cambridge AntibodyTechnology Group plc ("CAT") that are forward looking statements. All statementsother than statements of historical facts included in this press release may beforward looking statements within the meaning of Section 21E of the SecuritiesExchange Act of 1934. These forward looking statements are based on numerousassumptions regarding the companys present and future business strategies andthe environment in which the company will operate in the future. Certain factorsthat could cause the companys actual results, performance or achievements todiffer materially from those in the forward looking statements include: marketconditions, CATs ability to enter into and maintain collaborative arrangements,success of product candidates in clinical trials, regulatory developments andcompetition. We caution investors not to place undue reliance on the forwardlooking statements contained in this press release. These statements speak onlyas of the date of this press release, and we undertake no obligation to updateor revise the statements. This information is provided by RNS The company news service from the London Stock Exchange