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发帖数: 9638 | 1 Blockbuster Vaccine Could Be Pfizer's Next Hit
12/1/2011 12:00:00 AM
Emilio Emini’s battle with germs started early, when he was a working-class
kid growing up on Sullivan Street in Manhattan’s Greenwich Village and was
one of the first kids to get the oral polio vaccine—administered on a
sugar cube. If you ask him when the last outbreak of measles in the U.S.
occurred he’ll instantly tell you it was 1964, because that’s when he
caught it.
Fifty years later he’s finally got the upper hand on his longtime
adversaries. Emini, 57, is head of vaccine research at Pfizer, the world’s
largest drug company, where he’s pushing forward on a pneumonia
vaccine called Prevnar 13.
With $3.7 billion in annual sales Prevnar is already the bestselling &
shy;vaccine in the history of drug research and the biggest product that
Pfizer got from its $68 billion purchase of Wyeth in 2009. Sales could grow
60% to $6 billion by 2015 based only on the use of the vaccine in children,
according to investment bank Sanford C. Bernstein. If Emini can prove its
effectiveness in adults—which he is close to doing—it will add another $
700 million during that time period, Bernstein says. Pfizer thinks the adult
market is even bigger: $2 billion.
As anyone in the drug business will tell you, the timing couldn’t be better
for Pfizer, a $68 billion (sales) company with one of the worst track
records for developing breakthrough products in the industry and a stable of
top-selling drugs fast losing patent protection. After the legendary $11-
billion-a-year cholesterol drug Lipitor goes generic at the end of November,
Prevnar will become Pfizer’s top seller. Pneumococcus causes 175,000 cases
of pneumonia that require hospitalization and 6,000 deaths every year in
the U.S.
That makes Emini critical to the company’s fortunes, though you’d hardly
know it from talking to him. “The rush comes from the fact that once you
introduce a vaccine, if it’s a successful vaccine, within a very, very
short period of time the disease that you are immunizing against goes away,
” he says.
Tall, bearded and forceful, Emini is an unlikely corporate hero. As an
undergraduate he rode the subway to Manhattan College in the Bronx and went
to graduate school on a government fellowship. In 1983 he left academia to
go to Merck because, he says, “I really liked viruses.” His first project
involved the vaccine for hepatitis B, now the first shot given to children
when they are born. Then AIDS hit, and starting in 1987 he developed HIV
drugs such as Sustiva and Crixivan, among the first potent treatments for
the disease. In 1996 he was made head of vaccine research at Merck.
It was a heady time. His group developed vaccines against chicken pox,
shingles and human papilloma virus, which can cause cervical cancer, and
they were working on an AIDS vaccine. “We were able to actually get a lot
of stuff accomplished that, if the bureaucracy had had its way, wouldn’t
have happened,” says Alan Shaw, the researcher who had the office next to
Emini’s.
In 2004 Emini left Merck to try something new, he says. Others say Merck’s
new research chief, Peter Kim, was considering another guy to run
vaccine research. Either way, Emini departed, and Shaw and several
other top vaccine researchers left, too.
Emini’s first stop was the Gates Foundation-funded International AIDS
Vaccine Initiative. There he discovered that it was going to be “very, very
, very difficult to develop an HIV vaccine,” even with Gates’ billions on
his side.
So instead of solving the AIDS crisis, Emini went to Wyeth to work on
something more mundane: pneumonia. Their Prevnar vaccine was based on
technology Wyeth had purchased in 1994 that taught the immune system to
recognize sugars on the outside of bacteria.
A first vaccine using this tech nearly eliminated the haemophilus influenzae
B bacteria, once a leading cause of brain damage. Introduced in 2000,
Prevnar was already a success, reducing not only pneumonia and meningitis in
kids but also ear infections. It did such a good job getting rid of
pneumococcus that adults got sick less, too.
Emini saw huge potential for a new version that could prevent 13 different
strains, compared with the 7 covered by the original version. This Prevnar
13 would protect against a deadly, drug-resistant pneumococcus strain called
19A, which had been causing a rising number of infections in kids. Prevnar
13 might also reach a big new market: adults in hospitals undergoing
procedures like open-heart surgery, where pneumonia is a common and deadly
complication.
Wyeth executives wanted Prevnar 13 to reach the market in five years—an
almost impossible task. Emini flew to San Francisco and showed up at the
doorstep of another Merck expat, Kathrin Jansen, a German microbiologist who
had developed Merck’s Gardasil, the vaccine against the virus that causes
cervical cancer. She had left to work on anthrax vaccines. Emini put her in
charge of the most difficult part of getting Prevnar 13 to market: running
the tests on anonymous blood samples of patients in clinical trials to prove
Prevnar was turning on an immune response to the pneumococcus bacteria.
Dozens of her researchers worked around the clock in 10- to 12-hour shifts.
She held a party at her house to keep the group’s morale up. When Jansen
apologized to one scientist’s wife for keeping her husband away from his
small children, the woman responded that the vaccine work was too important
to society for her to complain.
Now success is close. A panel of FDA experts just recommended approving
Prevnar 13 for adults. And Emini has pushed forward on an 85,000-patient
clinical trial in the Netherlands to prove to doctors its effectiveness. If
the trial shows Prevnar 13 can prevent pneumonia, “the interest of
physicians and providers would shift very strongly toward that vaccine,”
says William Schaffner, chair of preventive medicine at Vanderbilt
University School of Medicine. Emini is optimistic. “We emptied out the HIV
wards when we introduced a new drug,” he says. “I’m begging to feel [
that] again. That’s a head rush.”
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