British Biotech plc - Marimastat Monotherapy Study in Ovarian Cancer Discontinued.

OXFORD, England--(BUSINESS WIRE)--Dec. 16, 1998--British Biotech plc announces that it is discontinuing one of its 11 marimastat pivotal studies, the European Phase III monotherapy clinical trial of marimastat in ovarian cancer patients. A combination trial of marimastat in ovarian cancer patients continues.

A detailed review of all ongoing Phase III marimastat studies was initiated earlier this year, which included consulting with external clinical and regulatory experts in the USA and Europe. It has now been concluded that the design of the ovarian cancer monotherapy study is insufficient for registration in ovarian cancer in either the USA or Europe because of its particular use of a composite measure to assess disease progression, as its primary end point.

The monotherapy trial was due to enroll a total of 300 ovarian cancer patients who would have received either marimastat or placebo. Recruitment commenced in November 1997, and as of December 1998, 64 patients had been recruited. The decision to discontinue the study is unrelated to the potential safety or effectiveness of marimastat in treating ovarian cancer.

Marimastat is an investigational new drug and the first of a new class of potential oral anti-cancer agents targeted to treat a range of solid tumors. Following today's announcement, 10 marimastat pivotal trials are continuing in six tumor types, including ovarian cancer.

Commenting on today's announcement, Dr. Peder Jensen, Development Director and Chief Medical Officer, of British Biotech plc, said: "During the recent marimastat pivotal trial program review, a question was raised as to the benefits of continuing the monotherapy ovarian cancer study. We therefore undertook further separate discussions with clinical and regulatory experts before taking a final decision. The consensus was that the design of this particular study was not sufficient to generate registerable data in ovarian cancer. For this reason, it makes sense to stop the study now and use the resources previously allocated to it elsewhere in the business."

This news release contains forward-looking statements which reflect the Company's current expectation regarding future events. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors including the success of the Company's research strategy, the applicability of the discoveries made therein, the successful and timely completion of clinical studies and the uncertainties related to the regulatory process.