BioWorld International Correspondent
LONDON Cambridge Antibody Technology Group plc could see its first product on the market next year following the announcement by partner Abbott Laboratories that it submitted D2E7, a human monoclonal antibody discovered by CAT, for approval in the U.S. and Europe.
If approved, D2E7 (adalimumab), for the treatment of rheumatoid arthritis, would be the first fully human monoclonal antibody to reach the market. The product, which blocks the activity of tumor necrosis factor alpha, has been the subject of 23 clinical trials involving more than 2,300 patients, some of whom have been taking the drug for more than three years.
CAT took a low-key approach to the news. Rowena Gardner, head of corporate communications, told BioWorld International, “It is significant, but it is what [Abbott] said they were going to do, so it is written into most [analysts’] models.”
Abbott previously forecast peak sales of US$1 billion. The product would compete with two other antibody treatments for rheumatoid arthritis, Remicade and Enbrel, which already are on the market. D2E7 has an advantage over both in that it is administered by injection once every two weeks, while Enbrel must be injected twice a week and Remicade is administered by intravenous infusion.
D2E7 originated from a collaboration between CAT, based in Melbourn, UK, and BASF Pharma, initiated in 1993. Abbott acquired the antibody when it took over BASF in March 2001.