Slough, UK and Cambridge, MA - April 24, 2002 -
Celltech Group Plc and
Biogen, Inc. today announced a collaboration for the research, development, manufacturing and commercialization of CDP 571, Celltech’s humanized anti-TNF? antibody product, which is in Phase III development as a treatment for Crohn’s disease.
Key terms of the collaboration are as follows:
Celltech and
Biogen will share ongoing research, development and registration costs and intend to
explore the use of CDP 571 in additional inflammatory conditions, such as
psoriasis.
Manufacturing of CDP 571 will be transferred following its launch from the current supplier to
Biogen’s state-of-the-art 90,000 litre
production facility in
Research Triangle Park, North Carolina, which will substantially reduce the cost of manufacturing the product.
Celltech and Biogen will each establish specialist salesforces to jointly promote CDP 571 in the US
and major European territories, except in
Italy where Celltech will have sole
commercial rights. The parties will share profits equally in these territories.
The agreement provides for Celltech to withdraw from joint promotion of CDP 571 should it
successfully gain registration for its third-generation anti-TNF? antibody fragment, CDP 870, in Crohn’s disease. In this scenario, Celltech retains its share of future profits from CDP 571.
The collaboration also provides Biogen, at its discretion, with the right to withdraw from elements of
the agreement if certain critical
milestones are not reached.
CDP 571 is a fully humanised anti-TNF? antibody, which is being developed as a potential treatment for Crohn’s disease and other inflammatory disorders. CDP 571 is currently being studied in two large international
phase III studies in Crohn’s disease, results from which are expected in mid-2002. In the U.S., CDP 571 has Orphan Drug status. It also has
FDA Fast Track Designation for steroid withdrawal in steroid dependent patients.