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Medicine’s New Millennium

New information about genes and proteins promises precise diagnostics and drugs. Millennium Pharmaceuticals’ CEO is at the forefront of this medical transformation.

With his casual clothes and slightly disheveled hair, Mark Levin doesn’t stand out in the scientist-infested Cambridge, MA, neighborhood that’s home to his company Millennium Pharmaceuticals. In biotech circles, however, the 51-year-old Millennium CEO and cofounder is known to be somewhat of a character.

First, there’s his professional background, which includes not only the typical stints as a drug company biochemical engineer, a manager at Genentech and a venture capitalist, but also forays into brewing and computer sales and marketing. Then there’s his uncanny ability to cut lucrative deals for Millennium with big pharmaceutical firms like Bayer and Pfizer, deals that have brought in some $2 billion and that, in some cases, give Millennium 50-50 rights to any drugs developed-arrangements unheard of before Levin hit the scene. And then there are the Halloween parties (Levin reportedly tends to show up in drag) and the CEO’s unending fondness for shoes, which he explains this way: “My dad had a bunch of shoe stores, tiny little stores, and so I actually grew up selling shoes. There’s nothing I like more than going shoe shopping.”

There’s an odd parallel between what excites Levin about the men’s shoe industry today and his vision for the future of medicine. Just as he lauds the proliferation of shoe styles and colors that lets customers choose a very individualized look, he looks forward to a day when one-size-fits-all drugs will be replaced with a wider variety of treatments, each specially tailored to an individual’s illness and genetic makeup. And with a staff of 1,500 and a 2001 R&D budget of $400 million, Millennium is one of the largest companies to throw its weight so decisively behind this idea of “personalized medicine.”

Technology Review senior editor Rebecca Zacks spoke with Levin a day after his eight-year-old company’s first drug had been approved by the U.S. Food and Drug Administration. Critics note that the anticancer drug did not originate in Millennium’s pipeline (the company acquired it when it bought a firm called LeukoSite in 1999). Still, its approval is an important step toward realizing Levin’s vision of a “biopharmaceutical” company-a biotech firm that actually produces therapeutic products. Levin’s enthusiasm for that vision, as well as his years of experience as a salesman, were plainly evident as he discussed his company, the drug industry and personalized medicine.

TR: What was the idea behind Millennium when you helped launch it?

Levin: In the late ’80s and early ’90s, I was in venture capital and got involved in starting up a lot of companies. I was hearing all this talk about the human genome, so I went out and spent part of my time in Europe and in the States visiting the major genome centers. I took a few years to meet all the people in academia and the industry and to get a sense of what was going on, and two or three key points came out of those discussions. One, the human genome would be sequenced within the next 10 years, so we would know what all the genes are. Even more importantly, people in medicine and science were saying that all human diseases had a significant genetic component-back then, that wasn’t common knowledge. When you thought about a genetic disorder, you’d think about cystic fibrosis. But we were beginning to realize that obesity and Alzheimer’s and cancer and every major human disease had a genetic component. This was the beginning of Millennium-building a technological and biological platform where we could actually get at the cause and pathway of all human disease, as opposed to the symptoms, by understanding the genome.

TR: How was Millennium’s strategy different from those of other biotech companies founded around the same time?
Levin: Everybody was excited about the genome, but as you might imagine, people thought about it differently. Some formed diagnostic companies by identifying mistakes or [diversity] in genes. Some built companies by compiling genomic information and selling the databases that arose from the information. Others realized that there were going to be important technologies to develop and you could sell these tools and form alliances around them. Millennium was focused from day one on building the biopharmaceutical company for the future by developing personalized therapeutic products.

TR: How has Millennium evolved since?
Levin: The vision is very consistent: identifying genes and proteins, thereby understanding the pathways that are involved in the causes of human disease, and developing products that are directly related to the causes. Over the last 10 years, we moved from genes to proteins [targets for drug discovery] to finding small molecules or antibodies that attack the targets, then into animal studies and now into human studies. And last night, we got approval for our first pharmaceutical product [a drug for a certain type of leukemia].

As the company has evolved, our overall strategy has focused on two key concepts. The first one is what we call personalized medicine; it’s finding the right target, finding the right drug for that target-and for that person. All of us in the future will be able to go into the doctor’s office with our genome on a chip, compare it to the available data on the genetic causes and pathways of different diseases and make decisions with our doctors about preventive and therapeutic medicine. It will tell us what we should be eating and not eating, and the kinds of tests we should be getting. And if we have a particular disease, it will assist us in choosing the best available therapies, based on our genetic makeup.

The second major effort, which is the biggest issue in the pharmaceutical industry today, is productivity. A major pharmaceutical company needs to produce somewhere between three to five new products a year to grow 10 to 15 percent a year. On average, companies produce one or two. So productivity is going to have to double and triple and quadruple over the next few years, or the industry will not survive as it is today. Millennium has put in place a technology platform from gene to patient to increase the productivity of the critical steps.

TR: As you describe it, personalized medicine will involve both tests for genes or proteins that might cause a person problems, and medicines tailored to that person and those genes or proteins. But right now aren’t we in a somewhat uncomfortable phase where we have some of the tests, but few of the medicines?

Levin: You are right-for the most part the tests have been out there first. But the field is changing rapidly-a new therapy for breast cancer is now personalized to the woman based on her expression of a particular protein. Products that Millennium develops going forward will in most cases have a test and a therapy together. Over the next five to 10 years, we’re going to see an explosion of not only these tests, but the integration of tests and therapy for personalized medicine.

TR: Whenever one of these tests comes out, particularly when it’s a gene-based test, there are questions about privacy. Is that something you take into consideration?
Levin: We absolutely do. Our chief business officer, Steve Holtzman [Holtzman has since left that position and acts as an advisor to Levin], was on President Clinton’s council for bioethics, and has been very involved in developing policy for the government with regard to privacy. We also recently opened a government relations department in Washington, DC. We believe in order for personalized medicine to be important in the future, one’s rights have to be protected.

TR: Does personalized medicine throw a monkey wrench into the economics of drug development? After all, if you’re making treatments tailored to patients with a specific genetic profile, aren’t you limiting the market for each new drug?
Levin: Well, it does and it doesn’t. Many products that would have actually failed in the past, because they were toxic on a very small percent of people, will now become very important products for the future because of the ability to determine who should and should not get the drug. Secondly, you’re going to get into the clinic and to the marketplace quicker because picking the patient population most likely to benefit for clinical trials will make it easier to prove a drug’s efficacy. Thirdly, when we get into the marketplace, products will have more activity and less side effects than today’s drugs, thereby being of higher value. And it is also important to remember that when a patient is put on a drug today, 20 to 40 percent of the people are taking a drug that will not work for them.

TR: Are doctors ready for personalized medicine?
Levin: It’s an important question. If we go back five to 10 years ago and look at the education for doctors, there was almost no training in genetics. Doctors were not getting the kind of training they needed to have a real understanding of how important these technologies are. Today, when you go into medical schools, you see much more integration of genetics and molecular medicine. Every day, we are meeting more doctors in academia and in practice who are very interested and beginning to implement personalized medicine.

TR: You regularly convince the top drug companies to give Millennium what BusinessWeek refers to as “obscene amounts of money.” How do you do that?

Levin: Well, first of all, we don’t think they’re obscene amounts of money-we think we should have actually gotten more. But what we’ve done from early on is to tell a vision for the future of the industry that is at the center of not only their profitability but also their survival. Our first alliance was in early 1994 with Roche, and we sat down with Jrgen Drews, who was the president of R&D and who has written a lot about productivity in pharmaceuticals. Right away, Jrgen and the Millennium team came to a real understanding and agreement about what the vision was. As we moved on and talked to other pharmaceutical partners, we found this same understanding about how critical our vision was for the future of genomics, productivity and personalized medicine.

TR: What’s in Millennium’s pipeline?
Levin: We’re developing three major businesses today: oncology, inflammation-which includes rheumatoid arthritis and asthma-and metabolic diseases, including obesity and diabetes. We now have seven drugs in the clinic. One of our most exciting drugs in the oncology pipeline is based on inhibiting the proteasome, which is a mechanism responsible for the orderly regulation of proteins and involved in the control of cell growth. We are now [conducting clinical trials of that drug for] multiple myeloma, pancreatic cancer, prostate cancer and many others. We’re also developing a molecule with Genentech for inflammatory bowel disease, Crohn’s disease and ulcerated colitis; this is an antibody that hones in on T cells that attack the gut. We also have drugs in the clinic for asthma and prostate cancer.

TR: Once you start marketing your own drugs, how does that change your collaborations with the pharmaceutical companies? Are you now the competition?
Levin: Well, it’s certainly been an evolution. Early on, we worked on just genes and drug targets; we would deliver targets to our partners, and we would get royalties on those as they become drugs. Today, we have 50-50 partnerships with Aventis and Abbott Laboratories where we work together to bring drugs from the gene to the market. However, I think it’s fair to say that just like pharmaceutical companies see each other as competitors, they are starting to look at us more as competitors. But it’s becoming a bigger world: the technologies are more complicated, the biology is more complicated, and in order to do all of this well, you do need to have partners. So although pharmaceutical companies now see us as competitors, they continue to see us as partners.

TR: Has the sequencing of the human genome changed the industry’s outlook?
Levin: In order to be a successful pharmaceutical company five and 10 years from now, each company’s going to have to understand not only the genome but the proteome, have the ability to pick the right targets by understanding molecular medicine, and know how to take the right targets forward into clinical trials. The ability to make those decisions will separate, I believe, the successful companies from the ones that are going to end up being merged into other companies.

TR: What is next for Millennium?
Levin: Over the next five to 10 years, our goal is to become a company that’s leading the world in personalized medicines, a company that is leading the world in productivity, a company with a value of over $100 billion, a company that has five to 10 products on the market that are making a big difference in people’s lives, a company with the strongest pipeline in the entire industry.

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