LONDON ¿ Cambridge Antibody Technology Group plc said it has signed a long-term agreement for the supply of its antibody drugs in the face of concerns that there is not enough manufacturing capacity to meet demand.
Medical Director David Glover told BioWorld International, ¿There are a lot of monoclonal antibodies in development, and we did the deal to secure manufacturing slots for clinical trials.¿ The agreement, with Lonza Biologics, guarantees that CAT has access to manufacturing capacity for up to five years.
Some of CAT¿s main competitors have announced similar manufacturing deals, and Glover said shortage of capacity could become an issue for the industry. ¿There certainly is, on the face of it, a shortage of contract manufacturing. Of course that could easily turn into a glut if a lot of people decide to invest in it.
¿This gives us security we can get material manufactured when we need it, and also offers comfort to CAT¿s current and future partners. The agreement builds on the fact that we are a volume customer and have a track record with Lonza.¿
CAT, of Melbourn, UK, has six monoclonal antibodies in clinical trials, though Lonza is not manufacturing all of them. It has 12 drug discovery programs and Glover said he expects four antibodies to be named as preclinical candidates in the next year. The agreement does not cover manufacturing for commercial sales.
At the same time, CAT announced that its founder and chief executive, David Chiswell, will leave after 11 years. Glover said, ¿The issue is having the right leader for the company at the right time. The company has grown from being a little research outfit to one with 300 employees and a broad range of international R&D programs and partners. To take [CAT] forward to be a profitable product company requires a different skills set.
¿In recognition of that, David [Chiswell] is to stand down when a suitable successor is found. We have initiated the process and believe being open about it will help the transition.¿
Emma Palmer, analyst at WestLB Panmure, said, ¿The news that a successor to David Chiswell is being sought is a surprise but a natural step for this maturing company.
¿Many biotechs have suffered from not realizing that the different stages of company development require different management, and CAT¿s search for a new CEO with more international and pharmaceutical experience reflects its expanding drug development pipeline and need for commercial focus.¿
It is anticipated that CAT¿s first product, D2E7, for the treatment of rheumatoid arthritis, will be launched in 2003. CAT partner Abbott Laboratories announced the completion of Phase III trials earlier this month, and said it expects to file in the second quarter of 2002. No data are available as yet on the outcome of the 2,000-patient trial.