BioWorld International Correspondent

LONDON - Cambridge Antibody Technology plc had a cheery start to the New Year with news that partner Abbott Laboratories Inc. received FDA approval earlier than anticipated to market Humira for rheumatoid arthritis, and the drug will begin shipping this month.

CAT Chief Financial Officer John Aston told BioWorld International, "This is hugely positive. This is the first product CAT has developed in part, to get approval. The importance in terms of the validation of our technology is considerable. This is likely to be a very big-selling drug."

However, given a royalty rate to CAT in the mid-single-digit range, Aston said the overall financial significance to the Cambridge-based company of the approval is limited. "This is not going to make us profitable. But it will bring in regular revenues, something we have not had previously."

Humira is the first fully human monoclonal antibody to reach the market. Abbott is throwing a high level of resource into the launch, and said last week that it expected this expenditure would lead it to lower 2003 earnings estimates.

Abbott, of Abbott Park, Ill., recently announced it was expanding its manufacturing capacity, and said it is confident of meeting demand for Humira, despite the earlier-than-anticipated launch.

Humira, which binds TNF-alpha, is injected every other week, an advantage over similar products that must be administered more frequently. The product will be available in a pre-filled syringe designed for use by patients who have limited use of their hands because of damage caused by RA.

European approval for Humira is expected in mid-2003. The product also is in Phase II development for the treatment of Crohn's disease.

Although CAT's royalty rate is modest, Aston said it was "the going rate for the kind of work we did, taking someone else's target, discovering an antibody, and giving it back to them for development."

CAT also announced a further cross-licensing agreement for its antibody phage display technologies, with Dyax Corp., of Cambridge, Mass., to add to the three other deals it announced late last year. Dyax will get access to all CAT's phage display technologies, and in return will cancel CAT's royalty obligations related to Dyax's Ladner phage display patents.

That agreement expands the 1997 deal between the companies. Dyax now has the right to use CAT's technology in its discovery programs, and has an option to receive a license for products developed under the CAT patents. In return, CAT will get milestone and royalty payments, and has an option to buy into Dyax products.

The royalty provisions of the 1997 agreement have been amended so that CAT will pay royalties to Dyax only on Humira, rather than the whole of its portfolio. In addition, CAT has the option to buy out the Humira royalty obligation.

In November, CAT said it would use licensing, rather than litigation, to protect its intellectual property, and to gain a share in as many successful antibodies as possible. At the end of December CAT announced license agreements with MorphoSys AG, of Munich, Germany, and Crucell NV, of Leiden, the Netherlands, and said litigation with the two companies was withdrawn. It also announced a cross-licensing agreement with XOMA Ltd., of Berkeley, Calif., for antibody-related technologies.