BioWorld International Correspondent

LONDON - Celltech Group plc agreed to a deal with Biogen Inc. to take over the manufacturing and share the development and commercialization of CDP 571, which is in Phase III trials for the treatment of Crohn’s disease.

The cost of manufacturing the drug pushed Celltech to do a deal with Cambridge, Mass.-based Biogen even though CDP 571 is in Phase III and Celltech has the resources to complete development and commercialization.

Peter Allen, chief financial officer at Celltech, told BioWorld International, “The problem with CDP 571 was the high cost of manufacture. Biogen will bring a significant reduction in these costs.”

CDP 571 is currently in two Phase III trials, with results due in mid-2002 and launch expected in late 2003. The compound has FDA orphan status in Crohn’s disease and fast-track designation for steroid withdrawal in steroid-dependent patients.

The companies will share the ongoing costs, and manufacturing of CDP 571 will be transferred from the current supplier, Lonza Biologics, to Biogen’s facility in Research Triangle Park, N.C., at Biogen’s expense.

Celltech and Biogen will jointly market CDP 571 in the U.S. and Europe, apart from Italy where Celltech, based in Slough, retains full rights. They will share profits 50-50.

But Celltech would withdraw from joint promotion if it gets approval for the follow-on product, CDP 870. However, it would retain a 50-50 profit share from CDP 571.

“Despite the high cost of manufacture, we were always going to launch CDP 571. But we would have been welcoming the point we could substitute CDP 870 because we would make more money,” Allen said.

The cost-of-goods burden meant Celltech previously had no plans to develop CDP 571, an anti-TNF-alpha antibody, in other indications. Under the deal with Biogen it will now be developed in psoriasis, and Allen said he expects trials to start in the second half of this year. “The feeling is that with Biogen driving it, CDP 571 could be a significant product in this indication.

“Overall, this deal extends the life of CDP 571 significantly. When we start selling CDP 870, Biogen will still be selling CDP 571, and it is not going to cost us anything to transfer the manufacturing to Biogen,” Allen said.

CDP 571 is the last product in Celltech’s pipeline that is manufactured in mammalian cells. All of the company’s other antibody-based products are manufactured, at lower cost, in microbial cells.