AstraZeneca enters human antibody therapeutics alliance

Under the terms of the initial five-year agreement, both companies are to invest equally, a minimum of $175 million (€132 million), which is to include a minimum of twenty-five discovery programmes. The principal focus of the discovery programmes will be in inflammatory disorders, with the research option that may extend to other therapeutic areas.

The agreement also sees CAT principally responsible for antibody discovery, manufacturing process development and the supply of material for exploratory clinical trials. AstraZeneca will be principally responsible for translational biology, clinical development programmes, regulatory filings and commercialisation. Joint teams will be established to oversee the full discovery and development process.

This latest deal with Astrazeneca​ emphasises the importance of CAT's research on human monoclonal antibodies in drug discovery and development. The great majority of approved monoclonal antibodies that are on the market today are chimaeric and humanised monoclonal antibodies, with a total of seventeen antibodies approved for commercial sale in one or more commercial territory. There are over 100 antibodies in clinical trial approximately 50 of which are human monoclonal antibodies.

Antibody-based therapeutics act by mimicking and harnessing the bodies own immune system. Monoclonal antibodies are potentially both efficacious and safe drugs with specificity for their target antigen. Human monoclonal antibodies are unlikely to cause adverse immunological responses in patients; a characteristic which undermined successful development of many murine and chimaeric antibodies in the past.

Peter Chambre, chief executive officer of CAT, commented, "This alliance in the field of inflammatory diseases represents a strategic move by CAT to deploy its expertise in early stages of product development and commercialisation."​

CAT is a biopharmaceutical company that focuses on human monoclonal antibodies in drug discovery and development. The company's proprietary technology isolates human monoclonal antibodies using phage display and ribosome display systems.

CAT​ also houses 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.

Humira, the leading CAT-derived antibody, isolated and optimised in collaboration with Abbott, has been approved for marketing as a treatment for rheumatoid arthritis in 51 countries.

CAT has recently entered into 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. This collaboration has so far given rise to one antibody product candidate at clinical development stage, and one at pre-clinical development stage.

According to Pharmaceutical Research and Manufacturers of America (PhRMA) Around 20 per cent of all biotechnology drugs in development are monoclonal antibodies. The sector is expected to grow rapidly as monoclonal antibodies are increasingly being regarded as a major category of drugs to treat serious diseases and can have a shorter time to market and higher success rates compared to traditional pharmaceuticals.

There is also believed to be a reduced threat from generic competition and the potential for premium pricing. Antibody drugs are expected to generate sales in excess of $6 billion in 2005, and it is thought that if 10 per cent of the antibody drugs currently in clinical trials prove successful, total sales could reach $45 billion by 2009.

Monoclonal antibodies represent the strongest growth area of in the therapeutic proteins market sector. By 2009, it is forecast that monoclonal antibodies will account for 48 per cent of all sales of therapeutic proteins.

According to market researcher firm, Datamonitor, oncology remains the leading therapy area, although the highest area of growth with be in the area of autoimmune/inflammatory and is expected to almost equal oncology in 2008.