By Mary Welch

In the company's first collaboration since its inception in late 1997, Millennium Predictive Medicine Inc. (MPM) entered a $70 million diagnostic deal with Becton Dickinson and Co.

MPM, a wholly owned subsidiary of Cambridge, Mass.-based Millennium Pharmaceuticals Inc., will develop pharmacogenomic and "Diagnomic" tests for cancer patients.

Becton Dickinson, headquartered in Franklin Lakes, N.J., will pay $15 million up front in an equity arrangement, and a $3 million licensing fee. The company, whose equity investment represents about 11 percent of MPM's voting stock, also will provide up to $51.5 million in research funding and additional annual licensing fees over the five-year deal, plus milestone payments and royalties.

"Both pharmacogenomics and Diagnomics recognize that individuals vary in response to specific drugs, according to [the patient's] underlying biological makeup," said Ken Conway, president of MPM and one of the company's founders.

"Say there are five different drugs that could be used for an indication," he said. "With our tests, a doctor will know better which one to choose, based on the patient's genes. It's customized treatment."

Pharmacogenomics is the study of how a patient's genes determine his or her response to a specific therapeutic. Diagnomics is a diagnostics system that produces a disease-state analysis using genomic and/or proteomic techniques. The system can describe a patient's current medical condition and provide prognostic and therapeutic information, and can suggest the best course of treatment - surgery, drugs, other intervention or no action at all - by looking at genes, expressed proteins or antibodies.

Overall, the alliance between MPM and Becton Dickinson will aim at developing tests designed to provide individualized diagnostic and prognostic information; assist in treatment selection for patients with cancer; and improve the prediction of a patient's outcome.

MPM will provide clinically validated markers to Becton for cancers of the cervix, breast, ovaries, uterus, prostate and colon, as well as melanoma.

The first clinical marker, melastatin, that will be delivered to Becton already is in clinical trials for melanoma, with a pre-marketing authorization filing expected by year's end. Tests for the other cancer indications are at least three years away, Conway said.

Melastatin is a protein encoded by a human gene Millennium identified in 1994. It may function as a metastasis suppressor in malignant melanoma, and it may also be a clinical marker for non-metastatic melanoma. The expression of melastatin correlates inversely with melanoma tumor thickness - the current predictor of patient outcome - and loss of melastatin expression correlates with the cancer's metastasis.

"When a physician does a biopsy on melanoma, it is a visual check, and the thickness is measured," Conway said. "Generally, the course of treatment is quite dependent upon the thickness. That works in about 95 percent of the cases. However, with our test, we may be able to determine that a more aggressive treatment may be warranted in [the other] 5 percent as well. It reduces the margin of error, and is a more individualized approach."

Becton will receive exclusive rights to all Diagnomic products (with the exception of colon cancer Diagnomic products for which it will have co-exclusive rights), and co-exclusive rights to all pharmacogenomic products developed in the collaboration.

Millennium's stock (NASDAQ:MLNM) closed Monday at $28, down $1.718.