West Coast Editor

Some might be skeptical, but Millennium Pharmaceuticals Inc.'s new president and CEO Deborah Dunsire targets 2006 for the firm to hit non-GAAP profitability, though "we're certainly not going to do stupid stuff just to take care of the short term," she said.

Dunsire takes over in August as the Cambridge, Mass.-based firm's replacement for Mark Levin, who also is Millennium's co-founder. To join Millennium she leaves her post as head of oncology operations in North America for Novartis Pharmaceuticals Corp., of East Hanover, N.J., the U.S. affiliate of Novartis Pharma AG in Basel, Switzerland. Dunsire worked for Novartis for almost 20 years.

Analyst Yaron Werber of Smith Barney Citigroup wrote in a research note that investors have "apparently lost confidence" in Millennium's ability to turn a profit by next year, particularly with Velcade (bortezomib), the company's marketed drug for multiple myeloma, under pressure from Warren, N.J.-based Celgene Corp.'s Revlimid (lenalidomide, a derivative of Thalomid, the company's brand name for thalidomide).

Celgene said last month the FDA granted priority review to its new drug application for Revlimid, with a PDUFA date of Oct. 7. The company wants approval to market the compound for transfusion-dependent patients suffering low- and intermediate-risk myelodysplastic syndromes with deletion 5q chromosomal abnormality, and an advisory panel is expected to review the matter in September.

"I don't know about anyone becoming disgruntled" with Millennium, Dunsire said, reiterating 2006 as the profitability goal. She aims to build on Velcade and Millennium's other market leader, Integrilin (eptifibatide), an anti-clotting agent for acute coronary syndrome, while "pulling [more drugs] through the pipeline as fast we can" and evaluating collaborations.

"We've had great partnerships in the past and we have some good key partnerships now," she said. Millennium signed a marketing deal for Velcade worth $15 million up front and as much as $500 million in milestones with Ortho Biotech Products LP, of Raritan, N.J., two years ago. (See BioWorld Today, July 2, 2003.)

Velcade was first approved for third-line treatment of multiple myeloma in May 2003 on data from a 202-patient Phase II study known as the SUMMIT trial, showing the drug increased median survival time in relapsed and refractory multiple myeloma patients to 16.4 months. They usually die six to nine months after they are diagnosed. The compound is being investigated in lymphoma and non-small-cell lung cancer. (See BioWorld Today, May 15, 2003.)

Dunsire declined to speculate on recent volatility in Millennium's stock, which some observers attributed to news coverage of positive Velcade data in the mainstream news media while others rumbled about a possible takeover.

"We don't comment on the daily stock price - so many things can change," she said. "The focus that we have is really on long-term growth." To achieve that, she said, the company will continue to work in its three preferred areas: oncology, inflammation and cardiovascular.

"No company can do everything and be active in every target and every pathway," Dunsire said, adding that Millennium will "continue to scan the outside world" for in-licensing candidates.

Christopher Raymond, analyst with Robert W. Baird & Co. in Chicago, wrote in a research note that he was "encouraged" by the hiring of Dunsire.

"One concern we have had with Millennium in the past has been a higher-than-usual rate of senior management turnover, which we hope this change may help address," Raymond wrote.

Dunsire acknowledged that intellectual capital is the "core" of success in the industry, and pointed out that the better people tend to seek jobs with more suitable companies. Though the brightest and most ambitious personnel can't be held at a firm where they would rather not be, "you can make [your firm] a very attractive place for them to work. My goals and the goals of this company are well aligned, in terms of people who want to make a difference in changing the paradigm of health care."

That new paradigm involves understanding pathways, Dunsire said, and the individual nature of illness.

"You can look at that tumor or inflammatory disease and say, This particular one has this phenotype,'" she said. Tumors, though they might be classified in the same way histologically, might be very distinct from patient to patient and require a more sharply focused approach - "as we know from prior experience with Gleevec," Novartis' drug for chronic myeloid leukemia that she helped launch, Dunsire said.

Even that approach, she said, "is just at its infancy."