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This article by Barbara Fox was prepared for the August 28, 2002 edition of U.S. 1 Newspaper. All rights reserved.

Lisa Drakeman’s Human Antibodies

There will be lots of exciting technologies in our lifetime,

but making antibodies has a big future and the market is growing all

the time," says Lisa Drakeman, CEO of Genmab, which is headquartered

in Copenhagen but has administrative offices on North Harrison Street

in Princeton. "Antibodies will continue to have important uses

regardless of other therapies that other people invent."

Using genetically engineered mice, GenMab creates and develops human

antibodies for the treatment of life threatening and debilitating

diseases. In the three years since it was founded the firm has signed

a total of 10 partnerships, has a product in Phase III clinical trials

to treat rheumatoid arthritis, and is partnering with two other firms

for a breast cancer therapy.

Genmab licenses its mouse technology from Medarex, the 15-year-old

State Road-based firm founded by Lisa’s husband Don Drakeman. Lisa

Drakeman was vice president of business development at Medarex when

Genmab was formed. Genmab’s Danish investor-founders asked her to

leave Medarex to head the new firm.

Vaccinate one of GenMab’s mice with a diseased cell,

and the mouse can create antibodies to fight that disease. Let one

of those antibodies multiply, and it will produce gallons of disease-fighting

antibodies to cure human patients. Monoclonal antibodies bind selectively

with a villain cell without affecting healthy neighboring cells and

with minimal side effects.

Antibodies are particularly useful for fighting cancer, because cancer

cells masquerade as "regular" cells and lull the body into

thinking everything is fine. Antibodies work as the sentries in the

immune system. "Their job is go around, look for trouble, and

send a signal to other cells — to the white blood cells —

to `get over here and do something,’" says Drakeman. "They

look around for something that doesn’t belong there and they attach

to it, signaling the rest of the immune system to jump on."

Monoclonal antibodies can be coupled to a drug, a toxin, or an isotope.

Or if they target various receptors on tumor cells, they can be used

by themselves. How the Genmab process works: the mouse gets vaccinated

with a purified version of a particular target, a cell from a tumor,

as well as with whole cancer cells. "This gives us a very good

response and lots of antibodies," says Drakeman. "We grow

up the cancer cell in an `in vivo’ model, and we are looking for the

antibody that kills the cancer the best. We might have 50 antibodies

and get it down to two or three, because the one that does the best

in the lab test is not necessarily the one that does the best in the

disease model."

"Good cancer targets are involved in signaling and good antibodies

interrupt the signaling process, which may be more important than

killing the cell," says Drakeman. "So we when we look for

a target, we have a list of what we want the cell to do. We spend

a huge amount of time after we make an antibody, going down the checklist,

to see if it does what we want it to do — to interrupt the signaling

and signal the white blood cells."

"Then, in the lab, we take the cell line, grow up a breast cancer

cell, put our antibody in, and see if it kills the cancer cell."

The only real competitor to Genmab or Medarex is California-based

Abgenix, which put up a stiff fight over the patents that were bought

for Medarex early on. The patents had been filed but had not yet been

issued, and they were so broad that Abgenix had to pay $40 million

to Medarex to even access its own technology. Now anyone wanting to

use human antibodies produced by genetically engineered mice has to

pay licensing fees to Medarex. Some competition is offered by companies

that make antibodies that are 90 percent human, under the assumption

that most patients will tolerate that percentage.

Lisa Drakeman says that, compared to antibodies made in other ways,

GenMab’s antibodies are at least 100 times better at getting where

they are supposed to go and staying there, and that they send better

signals. "We can use a fraction of the amount of material with

better results. If you are a patient, that is what you want to hear,

that killing more cancer cells with less medicine is a real possibility."

The previous methods for producing an antibody involved genetically

modifying the antibody to be acceptable to humans after the mouse

produced it. The only two therapies approved so far by the FDA were

devised with the old method, without benefit of the genetically engineered

mouse. Genentech holds the patent on Herceptin, a therapy for breast

cancer, and IDEC produces Retuxin, used for lymphoma.

The next win could be Genmab’s. It has a three-way collaboration with

Medarex and Oxford Glyco Sciences to work on breast cancer programs.

Drakeman is justifiably proud of how quickly and efficiently she has

built her young company. Founded three years ago, Genmab is the fifth

largest biotechnology company in Europe, and it is among the top 40

in the more crowded biotech space of the United States. "We have

a lot of cash, good infrastructure, and products in development,"

she says. "By year end, we will be the best funded, based on burn

rate."

"Where we distinguish ourselves is the ability to move things

forward. We are the youngest of the transgenic mouse companies, but

we are the only one in Phase III clinical trials with an antibody

from a transgenic mouse," she says. "It’s a team thing. We

work unusually well together. I consider our clinical development

and preclinical development teams to be the best in the industry.

We moved quickly, from Phase I to III in less than 2 1/2 years. My

job is to set goals and keep the team together."

But at least some of Genmab’s success can be traced to its inheritance

from Medarex. At its founding Genmab gave Medarex 31 percent of the

stock in exchange for 16 fee-free licenses to develop products using

Medarex’ genetically engineered mouse.

"What’s good for Genmab is good for Medarex because Medarex is

a shareholder, and we are helping to spread the technology," she

says. Medarex and Genmab are not in direct competition for the same

disease target, but as Drakeman points out, "there is competition

everywhere. One of the things that it is my job to do is to see that

Genmab gets the attention. Investors ask me all the time, `Why is

Genmab different?’"

Explaining the difference between the two companies, Drakeman says

that though Medarex does do some work on products, it focuses more

on licensing out its very valuable technology — the mice that

produce human antibodies. Medarex has an impeccable patent position,

so any company working with mouse-produced antibodies must pay licensing

fees.

In contrast, Genmab intensely focuses on product development and has

used five of its Medarex licenses. That it already has a broader pipeline

than Medarex is partly due to a very successful stock offering in

Copenhagen. "We raised a ton of money very rapidly in Europe,"

says Drakeman. "We are one of a small handful of product companies

in Europe, and we had a real window of opportunity. In Europe, it

is easier to get the attention of people who would be financing biotech

companies if you have a good company and a good plan."

Now Lisa Drakeman lives a bi-continental life, spending

an approximately equal amount of time on both sides of the Atlantic.

She has an apartment in Copenhagen, where Genmab has a 75-person headquarters;

a favorite hotel in Utrecht, the city in the Netherlands where Chief

Scientific Officer Jan G. J. van de Winkel has a 60-person laboratory;

and her office recently occupied the 20,000-foot second floor of 457

North Harrison Street, which will house up to 60 people, most of whom

will manage clinical trials. She sees her husband, Don, as often in

Europe and England as she does at home.

It’s also a high profile life. "Everybody in Europe knows who

I am. As far as I know I am the only women CEO of a public biotech

in Europe and there are only a handful of them in the United States,"

she says. The "good old boy" network operates less effectively

in biotech, which is a young industry. "You don’t have a group

of people who are all men, ahead of you." And in biotech, results

are what count, regardless of gender. "Because it is an entrepreneurial

industry, in some ways, it may be a little easier for women."

Lisa Drakeman grew up in New Hampshire, where her father was a forest

ranger. When the family moved to Pennsylvania, her mother, Jo Natale,

studied gemology and founded a jewelry store where her father and

one sister now work. Of the other two younger sisters, one is a psychiatrist

and the other a microbiologist.

She met her husband when both were college freshmen — she at Mount

Holyoke, he at Dartmouth, and they graduated in 1975. She worked at

the U.S. Treasury while her husband went to law school, and then they

moved to New Jersey, where she earned a master’s degree at Rutgers.

Both the Drakemans earned PhDs in religious history at Princeton University

and taught classes in the department. Their two daughters were born

during this period. One is now a graduate student in classical archaeology

at Oxford and the other is a sophomore at Haverford.

"Imagine going to graduate school with two preschoolers,"

she remembers. "When did I study? After they went to bed. I was

working pretty late. But it was important for me to finish my doctorate,

and I wasn’t leaving without it. I saw the women ahead of me not finish.

I was the only women in the decade of the ’80s to get a PhD in my

department. And the job market was tough. I certainly thought when

I was in graduate school that I would look for academic jobs but the

Medarex opportunity came up first."

She began working full-time at Medarex when the second of their two

daughters began grade school. "I honestly think that I was very

fortunate in my business experience. I reported to Mike Applebaum

(former CFO, now retired). There was a lot I could learn from all

the people I worked with and Don is on that list too. I had a nice

working relationship with people who were happy I was there. Not everybody

gets that opportunity."

While at Medarex, she was named "Advocate of the Year" by

the national Biotechnology Industry Organization. She established

corporate partnerships, managed clinical trials, and developed government

programs for financing biotechnology research.

Genmab’s North Harrison Street site is not a laboratory and no animal

testing goes on here, but mice are indeed used in Utrecht to produce

the human antibodies. What does Lisa Drakeman say to those who protest

the use of any animal, even rodents, other than the obvious reply

about how humanely they are treated?

"I say to people that in a perfect world we wouldn’t need to use

animals to develop new products, but if your choice is your wife with

breast cancer or the mouse, you would choose to develop the product

to treat your wife."

"Because there are antibodies on the market, people are getting

treatment they never had before. People are starting to realize there

is a business here, new medicine that is better than the old."

Only a few mice are used for the early tests, and at later stages

the antibodies are manufactured in a bioreactor. For now Genmab uses

contract manufacturers but has plans to buy its own. "Few biotechs

have made it to commercialization — which I will call success,"

she says. "But three years from now we hope to be profitable."

Genmab Inc., 457 North Harrison Street, Princeton

08540. Lisa Drakeman, CEO. 609-430-2481; fax, 609-430-2482. Www.genmab.com


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