Thoughtleader: Deborah Dunsire, Millennium

July 1, 2006

Pharmaceutical Executive

Volume 0, Issue 0

Figuring out the right drug for each manifestation of the disease is going to be critical. Because then patients know they're getting something that works.

In April, executives from Millennium Pharmaceuticals gathered in New York with the company's sales reps, investigators, and members of patient advocacy groups to ring the NASDAQ opening bell. They certainly had reason to celebrate. Sales of the company's multiple myeloma product Velcade (bortezomib), which it co-develops with Johnson & Johnson, had increased 19 percent during the first quarter of 2006, leading to an earnings report that exceeded analyst expectations. It also is marking its 10th year as a publicly traded company.

Deborah Dunsire, MD

New leadership also has buoyed Millennium: CEO Deborah Dunsire is closing in on her one-year anniversary as the company continues to realize the gains from its cutting-edge technology. The goal now is to build on those milestones. Millennium is seeking approval for new indications for Velcade, and is hoping to launch a product for mantle-cell lymphoma next year.

Here, Dunsire discusses what's ahead for the company, its success through partnerships, and why Millennium believes it can lead the pack in targeted therapeutics.

Pharm Exec: How is serving as Millennium's CEO different than running the cancer group at Novartis?

Dunsire: Novartis is a very established company; it has many years of history, many years of growth. So while everything that happens there is important, it's part of a very big whole. There are 80,000 people around the world. When you come to a company like Millennium, there are just 1,200 people, and every day counts. You really do see the personal impact that every single person has at Millennium every day. And that's exciting to be a part of.

The Holy Grail of the Future

People talk about biotech becoming all grown up. You've certainly had great success this quarter. How is Millennium growing up?

[Company founder] Mark Levin was a true visionary, a man who really saw where a new technology could go, and what it might yield, in terms of the human genome leading to an understanding of disease.

But then the company evolved to realize that that's not a business model per se; you have to translate that vision into discovering drugs and bringing them to market.

With Velcade on the market, we have sales we have to project and targets we have to meet, and that's a very immediate thing. You have to manage a very immediate focus and balance it with a strategy for long-term growth, because we're not about only today, we're about doing this for a long time into the future.

Part of that was focusing our strategy last year, because we understand that we can't be all things to all people. We made the difficult decision that we would focus only on oncology, because that's what our projected revenue base will support. When we do something, we want to do it well; we don't want to do a lot of things poorly.

How do you think about the growing competition in the oncology space?

I think about it in a lot of different ways. What's probably most relevant to Millennium is that cancer is 100 diseases. And nobody fully understands exactly what all the pathways are that make a cell cancerous. If you look back at early chemotherapy treatments, the first ones really were a bit like dropping a bomb—just try and blow up everything and hope the normal cells recover faster than the tumor cells.

But that's obviously not great for patients. So the goal is to determine what's switching on that cancer cell. Why does it do what it does? And then intervene with a drug that can get into that particular driving pathway. That's the heritage of Millennium: to really understand how genes turn on disease-oriented pathways. And that's why Millennium can compete in this type of space, because we've been doing it for a long time—12 years—and I believe that we have an edge.

Where does that edge come from?

Millennium is small enough for there to be a lot of collaboration between discovery researchers and drug developers. There's quick feedback. We're all headquartered in Cambridge, and there's an ability to really share information, and that's really powerful.

Millennium has forged 21 partnerships since 1995. What's effective about the way Millennium handles partnerships?

I think sometimes people go into partnerships as though it's a shotgun wedding: "I have a gun at my head, and I'll partner with you if I have to, but I'm not going to tell you everything." Millennium's a lot more open, and there's tremendous collaboration. And I think that's come through practice. Millennium has probably had more partners than any other biotech company.

Our collaboration right now with Johnson & Johnson on Velcade is truly remarkable. It's not that we always agree, but there's a very good dialogue about why we don't agree. And when you're really honest about what you're trying to accomplish, you can generally work out a compromise and reach an agreed-upon solution.

As Millennium grows, will the partnership model still be the right one for the company?

Would Millennium ultimately like to grow into a large global company? Yes. Can we do that now? No. To diffuse our resources and try to market Velcade outside of the United States would dilute us too much.

Partnering our compounds outside of the United States makes perfect sense to me right now. And the same logic would apply within the United States if we were working in a very large or very competitive indication. The investment that a company of our size would have to make to be able to shout as loud as everybody else would probably be too much for the company. We'd get beyond ourselves.

What have you learned from your partnerships?

I think we understand that strategic fit is very important. First, we had Integrilin (eptifibatide) in the marketplace, and we partnered with Schering-Plough to serve a very large cardiovascular market. But we didn't have a tremendous pipeline behind it, and we knew that we were not going to be a cardiovascular company in the future. We ultimately decided that it was better for this molecule to be with a cardiovascular-oriented company. So that was an example of focusing on a strategic core.

Likewise, when you're looking for a partner for a molecule like Velcade, it's important to look for a company that understands what you're trying to accomplish. If they are focused, for instance, on building an oncology company or if they've got a product with which yours fits nicely, there's much more likelihood that you'll have a successful partnership.

There's been a lot of scrutiny around price, especially in oncology. As you focus on that disease area, how does that shape your views on pricing?

We're passionate about going down the path of really deciding which medicines are right for which groups of patients, doing clinical trials with those patient populations—smaller trials—and getting faster approval. Even if a drug has 60-percent efficacy, it still means you're treating 40 percent of patients unnecessarily. Not every myeloma is the same, and figuring out the right drug for each manifestation of the disease is going to be critical. Because then patients know they're getting something that works. The system will also be better able to absorb the cost, because you're treating the patients that are going to get results.

Deborah Dunsire, MD joined Millennium in July 2005 from Novartis, where she led the US oncology business. During her time there, she helped develop and launch a number of Novartis products, including Zometa, Femara, and Gleevec. She also has worked as a clinical researcher and practicing physician. She graduated from the medical school of the University of the Witwatersrand, South Africa.