EDMONTON, Alberta - Biomira Inc. has agreed to sell its Truquant line of blood diagnostic kits for detecting breast, ovarian and gastrointestinal cancers to U.S-based Centocor Diagnostics Inc.
Biomira's sale of its diagnostics operation includes various antibodies and antigens for in vitro diagnostics purposes, plus the equipment used in product development. The diagnostic kits currently are manufactured at Biomira's wholly owned subsidiary in Toronto, Biomira Diagnostics Inc. No details of the sale were disclosed.
Several of Biomira's diagnostic kits are currently either in commercial production or at an advanced stage of clinical development. The Truquant BR RIA blood test kit for detection of recurrent breast cancer, for example, was launched in the U.S. last year, after a three-year clinical trial in patients previously treated for Stage II or Stage III breast cancer.
The kit incorporates Biomira's B27.29 antibody, which is designed to detect circulating tumor-related antigens in the blood of cancer patients.
Alex McPherson, Biomira's president and CEO, said the sale is part of a refocusing of priorities for the company.
In December, Biomira decided not to seek expedited Canadian approval of another diagnostic line. The Tru-Scint AD imaging kit, which uses a proprietary MAb-170 that reacts with most adenocarcinomas, was the subject of a Canadian new drug submission (NDS) in April 1996.
The submission was based on data from Phase II clinical trials in recurrent breast cancer as well as recurrent and primary ovarian cancer. In response, the Health Protection Branch of Health Canada advised Biomira that insufficient data were available to determine the statistical significance required for priority evaluation status.
In Phase II clinical trials of the Tru-Scint AD kit, the antibody, labeled with technetium 99m, demonstrated its ability to identify sites of recurrent breast cancer in women with suspicion of recurrent disease and to detect both primary and recurrent ovarian cancer. In both indications the accuracy of detection was greater than 85 percent.
In the absence of a corporate alliance, Biomira chose not to pursue the option of an NDS resubmission, announcing its intention to focus on its core competencies in cancer therapies.
Subject to Centocor Diagnostics' final due diligence on the Truquant kits and the signing of definitive agreements, closing of the sale is expected to take place at the end of April. Centocor Diagnostics is part of Centocor Inc., of Malvern, Pa.
The transfer of technology to Centocor is expected to take about four months to complete. In conjunction with the transfer, Biomira Diagnostics' 49 employees will be laid off. The Toronto manufacturing facility is expected to be closed in August.
“Our therapeutic vaccine program is the most exciting part of our business,“ McPherson said. “We have strong immunological data from our clinical and preclinical vaccine programs, and promising apparent survival advantage in patients with metastatic breast or colorectal cancers who have been treated with Theratope vaccine. We feel strongly that the decision to focus on cancer vaccines while maintaining a redefined positioning in diagnostics is the best decision we can make for our shareholders.“ *