By Mary Welch

Biomira Inc. sold its Truquant blood test kits for the management of breast, ovarian and gastrointestinal cancers to the diagnostics subsidiary of Centocor Inc. for up to $7.2 million — a move that Centocor hopes will make it easier to sell its own diagnostics assets.

Under the terms of the deal, Malvern, Pa.-based Centocor will pay Biomira minimum royalties of $5 million. Biomira also will receive two payments totaling $650,000, plus a potential additional $300,000 in milestone payments.

Robert Aubrey, vice president of manufacturing and sales for Edmonton, Alberta-based Biomira, said the company "decided, as part of our strategic planning, to focus on our vaccines and other cancer therapeutic products, and divest ourselves of other areas."

About four months after that decision, Biomira's Tru-Scint AD Imaging Kit, to identify sites of recurrent breast cancer, was not approved in Canada.

"So it's obvious we made the right decision," Aubrey said.

For Centocor, the purchase has two main benefits, said company spokesman Christopher Allman.

"The products that Biomira has are complementary to our diagnostic products," he said. "[Also,] we have been very public about our looking to divest our diagnostic products division, and buying Biomira's diagnostic products gives us a more complete package to offer to a buyer," Allman told BioWorld Today.

For its money, Centocor gets the Truquant BR, a blood test kit for breast cancer; Truquant OB2, a kit that monitors ovarian cancer; the Truquant GI-RIA for gastrointestinal cancers; and other diagnostic kits under development. Aubrey said the "lion's share" of the company's 1997 sales were of the Truquant kits.

Biomira's Toronto Plant To Close

Centocor also takes possession of an exclusive license with respect to various antibodies and antigens for in vitro diagnostic purposes and rights related to the sale of equipment used by Biomira's subsidiary, Biomira Diagnostics Inc., whose Toronto plant will close on or before Aug. 28 of this year, costing 49 jobs.

Centocor assumes responsibility for supply agreements to licensees currently using Biomira's antigens and antibodies in their automated diagnostic kits. The company, which posted first-quarter sales of $56.5 million, also has one year in which to decide whether to purchase the manual format of Biomira's STn Response Assay, which measures anti-STn antibody in the blood for common cancers.

Biomira also reported that its lead product candidate, the Theratope vaccine, has entered a "bridge clinical study," prior to starting Phase III trials, expected to begin in the fourth quarter of this year.

Theratope is a formulation involving a synthetic mimic of STn, a naturally occurring antigen found on cancer cells. The vaccine is designed to stimulate a patient's immune system to respond to and control cancer, with minimal side effects.

The Phase II trial involved 50 patients with metastatic or recurrent breast cancer who received one of three Theratope programs. The median survival rate of patients in the control group was 9.2 months. In one test, in which 25 patients received a low intravenous dose of cyclophosphamide followed three days later by the Theratope vaccine, patients showed a mean survival rate of 26.5 months.

Two other groups received either 12 days of an oral cyclophosphamide followed by Theratope, or Theratope alone. Median survival for all 50 patients in the three tests was 19.1 months, compared with 9.2 months for the control group.

Cyclophosphamide, a chemotherapeutic, jump-starts the immune system prior to Theratope's pushing it into high gear. (See BioWorld Today, Nov. 11, 1996, p. 1.)

In preclinical studies, a different formulation of the vaccine produced an antibody response 100 times more potent than the Phase II formulation, said Grant MacLean, vice president of clinical and regulatory affairs for Biomira.

"The question became, 'Why take into Phase III trials a vaccine that is less potent than another one we had?'" MacLean said. "Biomira and our partner, Chiron [Corp., of Emeryville, Calif.], decided you don't." Chiron will market the product if it gains FDA approval.

The new formulation being used in the bridge testing involves a higher dose of STn and a low dose of cyclophosphamide.

Begun in April and designed to show safety and antibody response, the bridge study includes 23 patients. Following the test, the company expects to enroll more than 900 patients in a Phase III breast cancer trial in North America and Europe.

Centocor's stock (NASDAQ:CNTO) closed Monday at $37.437, down $1.562, Biomira's shares (NASDAQ:BIOMF) ended the day at $2.562, down $0.062. *