BioWorld International Correspondent

LONDON - Celltech Group plc confirmed that it is scrapping CDP 571 in Crohn's disease, a move that comes a year after the anti-TNF-alpha antibody failed to reach the primary endpoint in Phase III trials.

The results at the time left the future of the compound hanging on discussions with regulators on whether approval could be granted for the management of disease flares, and for patients for whom alternative antibody treatments are unsuitable. However, last week Celltech's new CEO, Goran Ando, said CDP 571 would be dropped and the company would write off stock with a book value of £7.5 million.

CDP 571 was partnered with Biogen Inc., of Cambridge, Mass., in April 2002. Slough-based Celltech said they both agreed to end the collaboration.

The decision followed a review instituted by Ando when he was appointed in April. An analysis of the potential for CDP 571 on a named-patient basis concluded there was no significant patient population in which it would be "uniquely helpful." That was despite data from the Phase III trials showing that CDP 571 was effective in the acute phases of Crohn's disease and that it was well tolerated in patients who are hypersensitive to another antibody treatment, Remicade (infliximab, Centocor Inc., of Malvern, Pa., a Johnson & Johnson unit).

CDP 571 is the second major Celltech product to be dropped in the past five months. In April, Celltech partner Merck & Co Inc. ended Phase II trials of Celltech's phosphodiesterase-4 inhibitor, an oral treatment for asthma and chronic obstructive pulmonary disease. A follow-on product is in Phase I work.

The deciding factor that killed CDP 571 was cost - it was the last product in Celltech's pipeline that was still generated in mammalian cells, a method that is more expensive than using microbial cells. The antibody had a long history, having originally been developed for the treatment of septic shock, where it also failed in Phase III after Celltech's then-partner, Bayer AG, had spent $150 million on clinical trials.

Because of the high cost of CDP 571, Celltech always intended to substitute the follow-on compound CDP 870 as soon as possible, and said it is on track to start Phase III trials in the second half of this year.

The Phase III program will involve more than 1,000 patients and will incorporate acute and chronic endpoints. The Phase II data showed that CDP 870 might be especially beneficial in patients with elevated levels of C-reactive protein. As a result, the Phase III program will incorporate patient stratification, using baseline levels of the inflammatory marker when determining response to treatment.

Ando said completing development of CDP 870 in Crohn's disease was the most critical activity for Celltech in the near term.

"We are strengthening our late-stage development and specialist marketing capabilities to ensure this is successful and have put in place an innovative registration program to deliver the best possible commercial profile for CDP 870 in Crohn's disease," he said.

CDP 870 is partnered with Pfizer Inc., of New York, in rheumatoid arthritis and is in Phase III in that indication.

Celltech also announced further cutbacks as a result of Ando's review. A manufacturing facility in Santa Ana, Calif., will be closed in the second half of the year, with work transferring to the company's other U.S. plant in Rochester, N.Y. On the European pharmaceuticals side, 100 positions are to be cut following the creation of a specialist sales force in the UK and France.

Celltech shares fell by 10 percent to £3.32 when the company released the information in its financial results for the six months that ended June 30.