CAT and Genzyme collaboration

Cambridge Antibody Tech Group PLC 28 September 2000 For Further Information Contact: Cambridge Antibody Technology Tel: +44 (0) 1763 263233 John Aston, Finance Director David Glover, Medical Director Rowena Gardner, Communications Manager HCC De Facto (Europe) Tel: +44 (0) 20 7496 3300 Nikul Odedra (trade) Sue Charles (city/financial) Genzyme General Bo Piela (media) Tel: 001 617 252 7785 Sally Curley (investors) Tel: 001 617 591 7140 BMC Communications/The Trout Group (USA) Tel: 001 212 477 9007 Brad Miles, ext 17 (media) Jonathan Fassberg, ext.16 (investors) CAMBRIDGE ANTIBODY TECHNOLOGY AND GENZYME GENERAL TO COLLABORATE ON DEVELOPMENT OF HUMAN ANTI-TGF beta MONOCLONAL ANTIBODIES Melbourn UK and Cambridge, Mass. Cambridge Antibody Technology (LSE: CAT) and Genzyme General (Nasdaq: GENZ) today announced a broad strategic alliance to develop and commercialise human monoclonal antibodies directed against TGF-beta. All clinical indications, with the exception of ophthalmic uses, are covered by the agreement. The partners plan to focus initially on developing a fully human monoclonal antibody-based treatment for diffuse scleroderma, a chronic and life-threatening disorder in which the production of excess collagen leads to scarring of the skin and internal organs. About 40 percent of all patients with this disorder die within ten years of diagnosis. There is currently no effective therapy for the disease, which affects an estimated 200,000 people worldwide. Other potential clinical indications of anti-TGF-beta treatment include post-surgical scarring, fibrosis of all major organs such as the lungs, liver, and kidneys, and certain forms of cancer. 'Partnering with a world leader in the development of fully human monoclonal antibodies accelerates and substantially strengthens our anti-TGF-beta programme,' said Henri A. Termeer, chairman and chief executive of Genzyme Corp. 'This collaboration also represents an important expansion of our product-development strategy, in that we are developing a product with the potential to treat a wide variety of disorders affecting larger patient populations.' Dr. David Chiswell, chief executive officer of CAT, said: 'This collaboration with Genzyme offers us the opportunity to expand and accelerate our anti-TGF-beta programmes with a partner that is already committed to this area, and should prove to be a powerful combination that plays to both companies' core strengths. It is the first agreement that we have made for product candidates that we have developed through the preclinical stage into clinical trials and, as such, is a great endorsement of the product development capabilities that we have built in the company. This agreement enables CAT to take a greater share of the rewards of successful product development.' Terms of the Agreement Under the terms of the collaboration agreement, Genzyme has received an exclusive worldwide licence to CAT's fully human antibodies directed against TGF-beta for all uses excluding ophthalmology. Additionally, Genzyme has received a non-exclusive worldwide licence from CAT for non-antibody antagonists of TGF-beta in exchange for milestones and royalties. Research and development and commercialisation activities of the collaboration will be funded jointly and the partners will share profits. CAT will also receive significant credit for its contribution to the collaboration at the outset which will be applied to the calculation of future profit sharing. Genzyme will manage the clinical and regulatory development of any products developed by the collaboration, and will also be responsible for worldwide marketing and sales. CAT will be responsible for antibody optimisation and will co-develop antibodies with Genzyme. In addition, Genzyme will make a $20 million equity investment in CAT at a 15 percent premium to the average of CAT's share price over the 20 business days preceding the date of the agreement. 307,982 CAT shares will be issued to Genzyme at a price of £44.59 per share, giving Genzyme an equity stake of approximately 0.9 per cent in CAT. Application will be made to the UK Listing Authority for the shares to be listed and to the London Stock Exchange for the shares to be admitted to trading. It is expected that these shares will commence trading on Tuesday 3 October 2000. CAT has retained full rights for ophthalmology indications and will continue the development of CAT-152 and CAT-192 for these indications, expecting to bring in a specialist ophthalmology partner before marketing. Notes to Editors: Cambridge Antibody Technology (LSE:CAT) CAT is a UK biotechnology company using its proprietary technologies in fully human monoclonal antibodies for drug discovery and drug development. Based in Melbourn, 10 miles south of Cambridge, England, CAT currently employs around 180 people. CAT is listed on the London Stock Exchange, having raised £41m in its IPO in March 1997. A secondary offering in March 2000 raised £93m. CAT has a world-leading platform technology for rapidly isolating fully human monoclonal antibodies using phage display. CAT has an extensive phage display antibody library, currently incorporating around 100 billion distinct antibodies. This library forms the basis for the company's strategy to develop a portfolio of clinical development programmes and for discovering new drug leads using functional genomics. Four fully human therapeutic antibodies developed by CAT are at various stages of clinical trials. CAT has a number of license and collaborative agreements in place with pharmaceutical and biotechnology companies including: Eli Lilly, Pfizer, BASF Pharma, Genentech, ICOS Corporation, Genetics Institute, Wyeth-Ayerst, Human Genome Sciences, AstraZeneca, Oxford GlycoSciences and Pharmacia. Genzyme General (NASDAQ: GENZ) Genzyme General develops and markets therapeutic products and diagnostic products and services. Genzyme General has three therapeutic products on the market and a strong pipeline of products in development for the treatment of genetic disorders. A division of the biotechnology company Genzyme Corp., Genzyme General has its own common stock intended to reflect its value and track its economic performance. Anti-TGF-beta Monoclonal Antibodies TGF-beta is a naturally occurring growth factor that plays a central role in a number of biological processes. Prolonged production of TGF-beta has been implicated in scarring/fibrotic disorders such as diffuse scleroderma and pulmonary, renal, and liver fibrosis. It has also been implicated in a variety of autoimmune disorders and cancer. Animal model experiments have indicated that modulation of TGF-beta with neutralising monoclonal antibodies has the potential to have a therapeutic effect in reversing the progression of pathological scarring/fibrosis. Intellectual property relating to the therapeutic use of TGF-beta antibodies was licensed from The Burnham Institute in La Jolla, CA, the University of Utah and Integra, Inc. Genzyme has broad expertise in the biology and development of TGF-beta and a strong intellectual property position in this field. Genzyme's TGF-beta antagonist research and development programme is broad-based, covering antibody, receptor, and small-molecule approaches to TGF-beta modulation. Genzyme General is developing a number of compounds designed to inhibit the activity of TGF-beta, including its lead compound in this area, a murine pan-specific monoclonal antibody known as 1D11 which neutralises TGF-beta1, TGF-beta2 and TGF-beta3. Genzyme has been evaluating 1D11 as a potential therapeutic for diffuse scleroderma. As part of the collaboration, CAT will use its proprietary phage display technology to prepare a human analogue of 1D11. CAT has two anti-TGF-beta human monoclonal antibodies in development, CAT-152 (anti-TGF-beta2) and CAT-192 (anti-TGF-beta1), as well as a substantial intellectual property position in the field. Earlier this year, it completed a phase I trial evaluating the safety of CAT-192 in normal volunteers. It also announced in May 2000 positive one-year results from its phase I/IIa clinical trial evaluating CAT-152 as a treatment to prevent post-operative scarring in patients undergoing surgery for glaucoma. A multi-centre phase II trial is underway. CAT's ophthalmic programme, based around CAT-152, continues outside the collaboration with Genzyme. This press release contains forward-looking statements, including statements regarding the incidence of diffuse scleroderma and the efficacy of agents that modulate TGF-beta in treating pathological fibrosis. Actual results may differ materially based on many factors, including the accuracy of the parties' estimates of the number of patients with diffuse scleroderma and the results of pre-clinical and clinical studies of TGF-beta modulators.
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