CATCo Regulatory News (CAT)

1 Nov 2005 07:01

Cambridge Antibody Tech Group PLC01 November 2005 07.00 GMT, 02.00 EST Tuesday 1 November 2005 For Further Information Contact: Cambridge Antibody Technology Weber Shandwick Square Mile (Europe)Tel: +44 (0) 1223 471 471 Tel: +44 (0) 20 7067 0700Peter Chambre, Chief Executive Officer Kevin SmithJohn Aston, Chief Financial Officer Yvonne AlexanderRowena Gardner, Director of Corporate Rachel TaylorCommunications BMC Communications/The Trout Group (USA) Tel: 001 212 477 9007 Brad Miles, ext 17 (media) Brandon Lewis, ext.15 (investors) CAMBRIDGE ANTIBODY TECHNOLOGY ACQUIRES ONCOLOGY PRODUCT CANDIDATES FROM GENENCOR Cambridge, UK... Cambridge Antibody Technology (LSE: CAT; NASDAQ: CATG) todayannounces the acquisition of product candidates GCR-3888 and GCR-8015 fromGenencor, a subsidiary of Dansico, based in Palo Alto, California. GCR-3888 hasshown efficacy in a Phase I clinical trial and is currently in a Phase II trial for the treatment of hairy cell leukaemia (HCL). GCR-8015, an optimised version of GCR-3888, is in pre-clinical development as a potential treatment for B-cell malignancies including non-Hodgkin's lymphoma (NHL) and chronic lymphocytic leukaemia (CLL). The candidates are both immunotoxins comprising an antibody fragment that targets the CD22 receptor on B-lymphocytes fused to a toxin molecule. CAT has hired ten key former staff of Genencor who will continue to beresponsible for the development of these programmes, and has thereby establisheda CAT operation in the US for the first time. This will be based in Palo Alto,California. The consideration for the acquisition is up to US$16 million, of which US$14million will be paid by CAT on closing, expected to be Friday 4 November 2005.Simultaneously Genencor will subscribe US$14 million for 1,170,277 new CAT ordinary shares(representing 2.27 percent of CAT's existing issued share capital). CAT may be required to pay Genencor additional consideration of up to US$2 million, contingent on the availability for use in a clinical trial of bulk product material of GCR-8015 produced by Genencor. GCR-3888 and GCR-8015 were discovered and initially developed by the NationalCancer Institute (NCI), which is part of the US National Institutes of Health(NIH). Genencor licensed the candidates for haematological malignancies andentered into a cooperative research and development agreement (CRADA) with theNIH, which will now be continued by CAT. Under the original licence agreementwith the NIH, CAT will have rights to a portfolio of intellectual propertyassociated with the programmes and will pay future royalties to the NIH. The NCI has demonstrated significant efficacy of GCR-3888 in a Phase I clinicaltrial in HCL. The results of a trial in 46 patients, performed at the NCI, withCD22+ NHL (n=4), CLL (n=11) and HCL (n=31), was recently published in theJournal of Clinical Oncology (Vol. 23 No. 27 September 20 2005) including datafrom 265 cycles of treatment. Results showed that GCR-3888 was active in HCL,with 19 complete remissions (61%) and 6 partial responses (19%) in 31 patients.Lower, but significant activity, occurred in CLL. The publication concluded thatthe drug was well tolerated and highly effective in HCL even after one cycle oftreatment. CAT intends to file an Investigational New Drug (IND) application for GCR-8015in various CD22 positive B-cell malignancies, including NHL and CLL, following aperiod of manufacturing development which is expected to be complete by the endof 2006 and to support the NCI's ongoing development of GCR-3888 in HCL andpaediatric acute lymphoblastic leukaemia (pALL). GCR-3888 is an immunotoxin fusion protein between a murine anti-CD22disulphide-linked Fv antibody fragment (dsFv) and the Pseudomonas exotoxin PE38,and GCR-8015 is an optimised version of GCR-3888 with increased affinity forCD22. CD22 is a regulatory molecule that acts to prevent the over activation ofthe immune system and the development of autoimmune diseases. The anti-CD22immunotoxins GCR-3888 and GCR-8015 comprise a dsFv that targets the CD22receptor, fused with a specifically engineered toxin molecule that minimisesnon-targeted toxicity, resulting in a highly specific, highly potent therapeuticmolecule. The molecule acts by releasing the toxin intracellularly, after thewhole immunotoxin has been internalised via the CD22 receptor. Peter Chambre, Chief Executive Officer of CAT, commented: "The acquisition ofthese product candidates is a significant step forward, accelerating thedevelopment of our proprietary pipeline. In particular, they signal ourintention to focus our proprietary research and development activities inoncology indications, where we believe the opportunities are greatest for acompany of CAT's resources and technological capabilities. In addition, thetransaction has enabled CAT to establish its first presence in the USA. We aredelighted to welcome the development team associated with these importantproduct candidates to CAT. They provide a core of oncology development expertiseto CAT for the future." Dr Patrick Round, Vice President Development of CAT, commented: "Despite theprogress that has been made in treating patients with these forms of cancer overthe past decade, there remains a significant unmet medical need for thosepatients who are either refractory to the current treatments or whounfortunately relapse. GCR-3888 has demonstrated the potential opportunity fromutilising this immunotoxin approach in HCL and we look forward to exploring themechanism in a wider range of B-cell malignancies, including NHL and CLL, and toworking in collaboration with the NCI." Application has been made to the UK Listing Authority for the new 1,170,277 CAT ordinary shares, to be issued to Genencor, to be admitted to the Official List and to be admitted to trading on the London Stock Exchange's market for listed securities. It is expected that admission of these shares will become effective on Friday 4 November 2005. Notes to Editors: Cambridge Antibody Technology (CAT):Business: • CAT is a biopharmaceutical company, aiming to bring improvements to seriously ill patients' lives and thereby create outstanding returns for shareholders. CAT seeks to develop products independently and in collaboration with partners, using its capabilities and technologies in the discovery and development of new and innovative antibody medicines in selected therapeutic areas. CAT also seeks to licence its technologies to enable others to develop new medicines. Products: • HUMIRA, licensed to Abbott, is the first CAT-derived antibody to be approved for marketing. It was isolated and optimised in collaboration with Abbott and has been approved for marketing as a treatment for rheumatoid arthritis (RA) in 57 countries, and for psoriatic arthritis and early RA in some European countries and the US. • There are six further CAT-derived antibodies licensed to partners at various stages of clinical development: ABT-874 (Abbott), LymphoStat-B, HGS-ETR1, HGS-ETR2, ABthrax (all Human Genome Sciences (HGSI)) and MYO-029 (Wyeth). CAT has also licensed its proprietary technologies and patents to several companies. CAT's licensees include Abbott, Amgen, Chugai, Dyax, Genzyme, HGSI, Merck & Co, Micromet, Pfizer and Wyeth, and three antibody drug candidates are in clinical development at patent licensees. • There are two further human therapeutic antibody product candidates in clinical development - CAT-354, a proprietary CAT product and GC-1008, in collaboration with Genzyme. Collaborations: • CAT has a broad collaboration with Genzyme for the development and commercialisation of antibodies directed against TGF beta, a family of proteins associated with fibrosis and scarring, and with potential application in the treatment of some cancers. • CAT has a major strategic alliance with AstraZeneca to discover and develop human antibody therapeutics, principally in inflammatory disorders. This provides CAT with the opportunity to build a substantial pipeline of antibody therapeutics with a significant pharmaceutical partner. • CAT has a co-development collaboration with Zenyth (formally Amrad) against GM-CSF Receptor, a potential drug target in the development of RA. Science: • CAT has an advanced proprietary technology for rapidly isolating human monoclonal antibodies using Phage Display and Ribosome Display systems. CAT has extensive phage antibody libraries, currently incorporating more than 100 billion distinct antibodies, which form the basis for the Company's strategy to develop a portfolio of antibody-based drugs. Business Background: • CAT is based near Cambridge, UK, with a new site in Palo Alto, USA. 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 Genencor Background: • Genencor was formed in 1982 as a protein optimisation company to supply enzymes to the industrial, consumer and agri-processing markets. • In 2001, Genencor entered the healthcare sector and floated on the US stock exchange as Genencor, Inc. • In 2004, the company decided to focus its therapeutic activities on oncology and in December of that year in-licensed two anti-CD22 immunotoxin programmes from the National Cancer Insitute (NCI) - GCR-3888 and GCR-8015. A Cooperative Research and Development Agreement (CRADA) with the NCI was also entered to collaborate on the clinical and pre-clinical development of both programmes and to create a 'next-generation' anti-CD22 immunotoxin with reduced risk of immunotoxicity. • In early 2005, Danisco, a global supplier of food ingredients, acquired Genencor as a strategic move to help position Danisco as a major player in industrial enzymes. Danisco stated that it had no interest in maintaining Genencor's healthcare division and announced its intention to divest the assets on 1 August 2005. 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 company's present and future business strategies andthe environment in which the company will operate in the future. Certain factorsthat could cause the company's actual results, performance or achievements todiffer materially from those in the forward looking statements include: marketconditions, CAT's 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