By Randall Osborne

Already a major shareholder in Genentech Inc., Hoffmann-La Roche Ltd. acquired exclusive marketing rights outside the U.S. for Herceptin (trastuzumab), the company's monoclonal antibody for metastatic breast cancer.

"We went through an exhaustive program to find a European partner, but in the end, the evaluation committee and the executives determined Roche was the right one," said Marie Kennedy, spokeswoman for South San Francisco-based Genentech.

"It's a very nice financial deal for Genentech," she added. "The value increased because of the Phase III results."

Details were not disclosed, but the deal called for Basel, Switzerland-based Roche to pay what Genentech described as a "substantial" up-front fee, plus cash milestones. Roche, which owns about 70 percent of Genentech, will contribute equally to global development costs, and will make royalty payments.

In May, Genentech presented data from Phase III trials showing Herceptin used with chemotherapy slowed the progress of cancer and increased shrinkage of tumors that overexpress the HER2 oncogene. About 700 patients were studied. Also in May, the company submitted a biologics license application to the FDA for Herceptin. (See BioWorld Today, May 5, 1998, p. 1, and May 19, 1998, p. 1.)

Designated a "fast-track" product by the FDA, Herceptin will receive priority review, with a decision expected by November. If approved, Herceptin will be the first potential treatment for HER2 breast cancer, a particularly deadly form of the disease.

The marketing approval process in Europe is yet to begin, but Roche "is getting started on that right away," Kennedy said.

By binding to HER2 growth factor receptors — especially abundant on the surface of cancer cells — Herceptin neutralizes the receptors and retards tumor growth.

As part of the agreement, Roche and Genentech also began a joint global development program for other solid tumors, such as non-small cell lung cancer.

"Obviously, part of any therapy is starting to consider what other cancers you can study it in," Kennedy said. "Some of the other big cancers, like colorectal and prostate, are believed to overexpress the HER2 protein."

No significant development has taken place in those indications, Kennedy said.

"The focus right now is on getting the [FDA] advisory committee meeting and having the drug approved," she added.

Genentech is collaborating with Idec Pharmaceuticals Corp. to market Rituxan (rituximab) in the U.S. for the treatment of relapsed or chemoresistant follicular B cell non-Hodgkin's lymphoma. That arrangement made the Herceptin deal even more practical, Kennedy told BioWorld Today.

"It's really a good relationship, and allows us to work fast," she said.

Genentech's stock (NYSE:GNE) closed Monday at $68.25, up $0.312. *