Going for the Gold

You don’t have to know biotech
executive Mitchell Gold well for him to tell you about his mother’s death from
breast cancer. She died when he was just five years old.

The chief executive of
Dendreon, a Seattle company poised to market a new therapy for prostate cancer,
would rather talk about patients than profit. He points to his mother’s death
as fueling his passion to find new treatments for cancer, and he believes that
passion is shared by many of the roughly 400 employees of this research company
headquartered near Seattle’s waterfront sculpture park. Approval of the
product, Provenge, by the Food and Drug Administration is scheduled to come by
May 1.

Investors in the company,
unlike Gold, do want to talk profits, and expect big numbers from Provenge, a
revolutionary treatment for prostate cancer that some call a vaccine and one
doctor labels a “game-changer.” It harnesses the body’s own immune system to
help fight the cancer, and reportedly has few side effects. Yearly sales in the
United States are projected to reach $1 billion. The company won’t comment on
the sticker price Provenge will carry when it debuts.

Investors took the company’s
stock from near $3 a share to nearly $30 a share during 2009. The company estimates
about 103,000 men in the United States could be recipients of this new therapy.
Gold says the company will market exclusively within the United States, but
hopes to partner with someone else for European and global sales.

“[Chief Financial Officer Gregory]
Schiffman did a fabulous job to position the company to go to market,” says
David Miller, president of Biotech Stock Research LLC, an analysis firm in
Seattle.

To ramp up in advance of the
launch, Dendreon expects to hire about 200 new employees in sales and
administration. While some will be in one of the company’s three leased
buildings in Seattle, many of the new hires will join existing employees at its
Morris Plains, N.J., manufacturing center and laboratory. Two other lab sites,
in Atlanta and Orange County, Calif., are set to be built and ramped up to
begin making Provenge in 2011, if all goes as planned. The company sold 15
million new shares of stock in December, raising $409 million to build the
plants and support other operational costs.

Dendreon hopes to more than
double the size of its Seattle headquarters, according to Schiffman. It leases
about 95,000 square feet now, but intends to move to a space of about 250,000
square feet in the South Lake Union area.

Both Gold and David Urdal, the
chief scientific officer, showed persistence and patience in overcoming
obstacles on Dendreon’s way to this commercialization phase. The original FDA
application, filed in 2007, was not approved and they were asked to produce
more data for a resubmittal filed last November. Urdal has been in this hunt
for 14 years.

“When you have a deeper
commitment, that’s what drives you through the tough times,” he says. Urdal, a
veteran of product development, helped Seattle’s Immunex develop the drug
Enbrel for rheumatoid arthritis, before Immunex was sold to Amgen in 2001. He
holds a doctorate in biochemical oncology from the University of Washington.

“I have a belief in the
potential of the [Provenge] platform,” Urdal explains. What he calls “the
platform” is the underlying mechanism behind Provenge, which can be adapted to
work for other cancers, if its potential is realized. (See “How it Works,” p.
18.)

Dr. Neal Shore, a urologist
from South Carolina who has conducted research with Provenge, called it “truly
historic and a game-changer” when he spoke with stock analysts last year.

Changing Gears

Bringing a product to market is
a very different path for a company that has focused solely on research. Two
questions loom: Will Dendreon survive the metamorphosis to a manufacturing and
sales engine? Will it get gobbled up by a big company, as has happened to other
Seattle biotechs?

Three new faces hope to help
transform Dendreon into a sales machine. One is Hans Bishop, named late last
year to be chief operating officer. Bishop most recently served as president of
the specialty medicine business at Bayer, where he was responsible for a
diverse portfolio of oncology, hematology and neurology products.

The other two are newly elected
members of the board of directors, Ian Clark and Pedro Granadillo. Clark became
chief executive of Genentech, which is itself a subsidiary of the Roche Group,
on Jan. 1. Granadillo, who is now retired, was formerly chief of global
manufacturing and human resources for the pharmaceutical giant Eli Lilly &
Co.

These directors bring decades
of product and marketing savvy to the commercialization process. One of the key
challenges for Dendreon, as many analysts have remarked, could be meeting an
overwhelming demand when the approval finally comes through.

Pent-up demand is one reason to
watch Provenge when it hits. An estimated 103,000 men in the United States have
refractory prostate cancer, meaning it no longer responds to existing
treatments. These men, and the oncologists and urologists who treat them, are
very likely to already know about Provenge, according to a survey reported to
stock analysts last December. Due to the 2007 application delay, many patients
and doctors have lobbied for approval of Provenge, so its visibility is
heightened.

“We have the right people on
board,” Gold says, to meet each challenge. He is a compact man who brings a
sense of balled-up intensity to his conversations. A former urologist, he
worked in a medical information business before joining Dendreon nine years ago.

As part of what it calls a
stepwise strategy, the company’s existing facility in New Jersey, which
functions as both manufacturing plant and treatment site, is already operating
at 25 percent capacity. The business plans to increase that to full capacity by
the end of 2010 if the FDA approval comes on time. The two new sites are
strategically located near the highest populations of prostate cancer patients
in the United States.

Another potential challenge is
the unusual method by which patients are treated with Provenge. Rather than a
drug taken orally or intravenously, the patient provides three blood samples,
which are sent to the lab to be tested, and where the white blood cells are
treated with antigens to target prostate cancer. The blood is then sent back
and injected back into the patient. This presents logistical challenges with
the transportation and tracking required by handling three separate blood
samples from each patient, shipping them to the lab and back to the patient’s
doctor, all within about one month.

Company leaders point to the
software they call Intellivenge, which was created to streamline the tracking
system. Patients and doctors will be able to see the progress of a specific
blood sample as it makes its way from donation to return. Each bag of blood
cells will carry a bar code and frequent scans will keep the location of those
cells available to patients and doctors.

While it may seem cumbersome,
Urdal explains that this system of moving blood products around the country is
not complicated for patients or their doctors. A doctor writes a prescription
and a patient will phone Dendreon to begin the process. Blood is drawn at a
blood center, which already routinely handles what is called leukapheresis. By
this method, the patient’s white cells are separated from the whole blood
sample and only those are sent to Dendreon.

The patient’s own doctor gives
the white blood cells back to the patient using an intravenous drip, in an
office procedure that is a common way for chemotherapy to be administered. The
only side effects routinely reported are flulike symptoms, which many patients
find mild in comparison to the side effects of conventional chemotherapy and
radiation treatments.

So far, Provenge has been given
in clinical trials to patients who have already had surgery and/or radiation
for their cancer, as well as hormone therapy. It is a treatment of last resort,
after other regimens have failed. But its market could also expand if it proves
helpful when given earlier in the management of the disease.

This question-refining and
tweaking how the therapy is given-belongs to the continuing research world of
Dendreon.

Where Curiosity is King

Many challenges remain about
the very complex human immune system, and the scientist Urdal’s eyes twinkle
brightest when he gives a tour of a place where curiosity is king, the
immunologic laboratory at a Dendreon building in Seattle. Urdal is tall and
willowy, and his eyes seem too young for the snow-white beard that hovers over
his lab coat.

Here, scientists are probing
the markers or measurements of immune response, and peering into the
step-by-step processes inside the cells of the patients receiving Provenge, and
other therapies like it, to gain basic understanding.

With more of that
understanding, new therapies can emerge, with new antigens, timed ever more
precisely to take advantage of the body’s strengths but to avoid the
weaknesses.

“Drug development is the best
team sport in the world,” Urdal says, “250 people, all pulling in the same
direction.” His number may be out of date. The company hopes to have almost 600
employees by the time Provenge hits the market.

This story has been corrected. The original version misstated when Mitchell Gold’s mother died.