Pioneering a Vision, Making It Reality

Millennium was founded in 1993 in Cambridge, MA; by May 2003, after a decade of sophisticated science and intense deal-making, it had its first marketed product: Velcade (bortezomib).

Velcade looked like a winner: It was the first FDA-approved proteasome inhibitor, the first approved treatment for multiple myeloma in more than a decade (it is also approved for second line treatment of mantle cell lymphoma), and the second fastest drug approval (at 10 weeks) in history.

This was bad news for Millennium. Velcade was the company's only marketed product; promising candidates such as MLN-0002 for ulcerative colitis and Crohn's disease lagged many years behind it in the pipeline. "The $2 billion oncology division at Novartis is less than 10 percent of the whole," says Dunsire. "But at Millennium, the success of the company and the ability to invest in your portfolio, to achieve your mission and vision is totally dependent on that one product."

In other words, for Millennium, Velcade had to work.

Many were doubtful that it could. "[Dunsire] stepped in at a time when competitive threats were heightening, and people wondered if Velcade could compete against an emerging competitor," says Christine Poon, the new dean of Ohio State University's Fisher School of Business, and former vice chairman of Johnson & Johnson, Millennium's partner in Velcade. "There was doubt about whether she could position the product and the company to make people believe that it could grow, and that the pipeline was something to be excited about." Headlines echoed the sentiment: "The Future Millennium Isn't So Exciting," opined investment Web site The Motley Fool.

But Dunsire had a vision for how to get Velcade—and Millennium—to achieve their potential. First, she addressed what she called the "burning fire" (there was no commercial head) by hiring Christophe Bianchi, a seasoned oncology exec who had previously run Sanofi-Aventis' $2 billion cancer business. Together, they brought Big Pharma sales and marketing know-how to the table, doubling the size of the sales force.

They also simplified the drug's selling points. "Velcade is a great drug, and there is a gold mine of things you can say about it," says Christophe Bianchi. "But at the end of the day, the customer will only remember a couple of them, not 20. You have to choose what to say—and also what not to say."

Velcade sales started to grow again. In 2006, a 20 percent increase for Velcade put Millennium in the black with a net profit of $8.3 million. But what really changed the trajectory of the drug was the expanded FDA approval to use Velcade in first line multiple myeloma patients in 2008. (It was originally approved in 2003 as a third line therapy, then in 2005 as second line.) By November 2008, Velcade was a blockbuster.

Certainly, the drugs will continue to jockey for position. Revlimid also became a blockbuster in 2008, bringing in $1.3 billion. There's also evidence that the drugs work well in combination. "I can see two winners in this game," says Howard Liang, an analyst for Leerink Swann. "There is room for both drugs to increase penetration of the first line setting, and then eventually combine and continue to grow."

Revlimid never swept the market the way many expected, thanks largely to Velcade's promotional response. Baird analyst Chris Raymond predicts that sales of Revlimid are likely to disappoint in 2009 due to strong competition from Velcade.

Meanwhile, Dunsire saw another problem—sweeping R&D spend, without much to show for it. "I tend to simplify things, as opposed to looking for complexity," she says. "I remember saying, 'The arithmetic doesn't add up. The R&D budget's wildly bigger than the revenue, and we just have to fix that.'"

Under founding CEO Mark Levin, Millennium started out as a genomic-based company, but it expanded to include efforts in inflammation as well as oncology. Dunsire worked with the R&D team—Joe Bolen, Nancy Simonian, and Pete Smith—to decide where to scale back. "It's not just a resource or scale issue, it's also about where your skills are," says Dunsire. Ultimately, the team decided to focus exclusively on oncology. The decision was a hard one, mostly because it meant laying off workers. Ultimately, though, the move to focus the company promised to be the key to its future success.

"When Deborah came into the company, she certainly spent a lot of time on the commercial side. Given her background, that was natural," says Christine Poon. "But what impressed us is how much time she spent with her R&D organization—looking at the pipeline and where to allocate resources, and making the tough decisions on where to focus."

"She got us focused on what was important," says Mark Levin, now a partner at Third Rock Ventures, who remembers meeting Dunsire and getting excited about her commitment to doing great things. "When you bring a product to market, especially in a small company, it's a long haul. We got part of the way, but Deborah came on board and took our capability to market and sell up by an order of magnitude."

Others see Dunsire's value not only in the skills she brought to the company, but also in her ability to lead. "Few CEOs have stepped into more challenging situations," says Marsha Fanucci, Millennium's former CFO. "She inherited the legacy of an audacious company vision, a great but under exploited product, and an operating infrastructure that was by any measure suboptimal. Perhaps most important, she followed a CEO who was an inspirational leader loved by all. So many ways to fail, yet through her leadership she unlocked the potential of the product, and even more important, the people."