ByNuala Moran

BioWorld International Correspondent

LONDON - Celltech plc said it expects to file for approval of its lead product, CMA 676, in mid-1999, following further promising results in a pivotal U.S. study involving first-relapse patients suffering from acute myeloid leukemia. The company also said it is on track to file for approval of CDP 571, a humanized anti-TNF alpha antibody, for the treatment of Crohn's disease in 2000. If the two registrations take place, Celltech will move into sustained profitability in the year ending September 2000.

Shares in the company rose by #0.125 to #4.35 (US$7.36) when Celltech, based in Slough, made these statements as it disclosed results for the fiscal year ended Sept. 30. These showed a loss reduced to #3.1 million from #12.1 million in 1997, on revenue up to #11.7 million from #4.3 million. Much of this increase came from licensing income arising from Celltech's Boss antibody manufacturing technology.

The company ended the year with #40.2 million in cash, up from #36.3 million, despite increasing its research and development expenditure to #21.5 million from #18.2 million in 1997.

Interim results from the pivotal U.S. study of CMA 676, being carried out by Celltech partner American Home Products (AHP), of Madison, N.J., were presented last week to the American Society of Hematology meeting in Miami. They showed that of 23 patients in the initial group, 10 had a complete or major response to treatment, characterized by complete elimination of clinically evident leukemic cells. Of these, three showed complete remission. A total of 90 patients have now been treated, with similar results. Side effects of the treatment are low, and it can be administered in outpatients.

Celltech had retained European marketing rights, but it has now granted these to AHP in return for an improved worldwide royalty rate.

Patient recruitment has been completed in a Phase IIb study of CDP 571 in Crohn's disease, and is close to completion in a second study. The compound has been granted fast-track status by the FDA, and Celltech is currently seeking a partner for the compound, for which it expects to seek approval in 2000. n