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Coping
with Complexity
Pharmaceutical
compounds are getting larger
and more complicated.
Boehringer-Ingelheim's R&D shop
in Richmond figures out how to
process them more efficiently.
On
the third floor of the Biotech One
building at the Virginia BioTechnology
Research Park in Richmond, Va., Dr. Jack
Brown skims over the screen of his
desktop computer. He’s illustrating a
point crucial to the pharmaceutical
industry and, in particular, to his
company, the German firm of
Boehringer-Ingelheim, the 14th largest
drug maker in the world.
New
drugs are becoming more complicated and
difficult to mass produce. By way of
comparison, Brown nods at the screen
showing the chemical formula for AZT, a
pioneering drug introduced in the early
1990s to fight the alarming and then
relatively new AIDS virus. AZT was
considered a major advance at the time,
and its formula shows a series of rings
typically associated with organic
chemistry.
Next,
he flips onto the formula for a newer
drug, called a fusion inhibitor that was
developed a decade later to prevent the
AIDS virus from spreading by preventing
it from linking with cells. Its much
longer formula looks like a length of
crochet, perhaps 15 times the size of
the AZT formula. “This one has 109
chemical step processes while AZT has
two,” he says.
Brown’s
point is that the ever-growing
complexity of new drugs is a big
challenge for Boehringer-Ingelheim, a
privately-held, family-owned company.
The Virginia BioTechnology Research Park
plays a major role in Boehringer’s
drug making by helping the firm prepare
its products for market in ways that are
safe and cost-effective. The park houses
several offices and laboratories for its
chemical, pharmaceutical and
veterinarian drug divisions. They help
prepare new drugs for clinical trials
and provide research and development
services for Boehringer’s large
production facilities in Petersburg.
Complexity
is important to Brown, manager of
process development for
Boehringer-Ingelheim, because
rather than coming up with the new drugs
themselves, BI’s Virginia group takes
drugs originating in other Boehringer
labs, usually in Europe, and finds ways
to put them into tablet or injection
forms that can be mass produced. The
task is difficult because the 13
scientists in Brown’s lab, along with
specialists in other Richmond-Petersburg
units of Boehringer, must find ways to
make pills that are environmentally safe
and cheap enough to mass market. “For
us to supply drugs economically is very
challenging,” says Brown, who has a
Ph.D. in chemistry.
To
supply drugs in bulk, Boehringer’s
Virginia contingent makes sure that the
coatings surrounding each tablet are of
the right, time-release consistency so
they enter the patient’s bloodstream
in the right part of the body. Any
additives must be safe for patients, and
they must be cheap enough to offset the
costs of the drug itself. The simple
aspirin table, for example, may weigh 1
or 2 grams, but has only 500 milligrams
of aspirin. The rest of the tablet
consists of additives such as starch,
Brown says, to make sure “it is
released in the lower gut as intended
for pharmaceutical purposes.”
All
in all, Boehringer has about 380
employees in the Richmond area. In 2003,
Gov. Mark Warner traveled to the
company’s headquarters in the city of
Ingelheim and announced the firm will
expand its manufacturing capacity at the
Petersburg manufacturing facility. The
new investment, aided with a $1.75
million grant from the Governor’s
Opportunity Fund, could reach $260
million and employ 165 more workers by
2011.
The
chemical company also has qualified to
win a $3 million grant from the Virginia
Investment Partnership. Not only does
the Petersburg facility prepare
proprietary drugs for the mass market,
it makes huge vats of other drugs for
sister pharmas. The plant, for instance,
produces a drug called Guaifenesin that
is a key ingredient for the familiar,
over-the-counter cough-syrup Robitussin,
produced by Wyeth Pharmaceuticals.
Following
the Petersburg expansion, the group at
the Virginia BioTechnology Research Park
is due for some kind of growth since its
work load will increase. Brown says
expansion details are still being worked
out.
A
key reason for Boehringer's keen
interest in
Virginia is its location in the vital
American market. As the company’s
annual report notes, “The U.S. is
assuming an increasingly important role
as the driver of business development.
Germany, although it continues to play a
central role in terms of research and
production, primarily for the
company’s foreign business, is, on the
other hand, witnessing rapidly declining
significance as a market.”
Boehringer-Ingelheim has annual sales of
$10.1 billion, of which $7.6 billion are
pharmaceuticals. About 60 percent of the
drugs are sold in the U.S.
“The
company is held in very high repute
because of its biologics
manufacturing,” says Gil Y. Roth,
editor of the trade journal "Pharma."
While the firm is in the second tier of
drug makers, Roth says its products do
well on world markets.
The
Richmond R&D facilities are
well-located, according to Brown. While
Boehringer’s North American’s
headquarters are in Ridgefield, Conn.,
near the global crossroads of New York,
Virginia operations are close to the
Research Triangle in North Carolina, and
the University of Virginia. Labs around
Washington, D.C., and points north also
are near at hand. Being so close to the
Virginia Commonwealth University Medical
School and other lab workers in the
biotech park is a major plus, Brown
says, because scientific libraries are a
walk away, clinical tests can be
conducted at VCU, and workers from other
biotech labs in the park can make a
quick trip to Shockoe Slip or Bottom to
talk shop at lunch or after work.
Talking shop among peers is a crucial
facet of exchanging ideas.
Brown’s
Richmond lab is working on some major
new drugs for Boehringer-Ingelheim,
whose best known products include the
prostate-cancer fighting drug known as
Flomax which had sales last year of $913
million, according to “Pharma.” The
next best selling drug is Mobic, used to
treat rheumatic disease, followed by
Micardis for hypertension.
Typically,
Boehlinger releases its drugs first in
Europe and then in the U.S. which
represents about 60 per cent of
Boehringer’s total sales. The
company’s goal is to eventually make
drugs in the U.S. so as to avoid import
duty fees.
Right
now, the company is gearing up for U.S.
production of Tipranavir, which is being
manufactured in in Europe already. The
drug, one of a line of Boehringer
products used to fight the AIDS/HIV
virus, is a protenase inhibitor that
interferes with the development of the
AIDS virus from a juvenile to its deadly
adult state. Says Brown: “Our role is
to make sure that the manufacturing
process goes smoothly.”
Another
in the drug family used against AIDS is
Viramune, which had sales last year of
$350 million. The drug, which helps
prevent the spread of AIDS from an
infected mother to her child, was
discovered at Boehringer’s Ridgefield
labs and then introduced in Germany
about 10 years ago. “Boehringer gives
a lot of that away in Africa,” says
Brown. Now, the company is ready to
launch a more advanced AIDS medicine
called Aptivus.
The
Richmond units also work on drugs
related to combating Hepatitis C, an
even bigger killer than AIDS. Brown
notes that while 50 million around the
world might be infected with AIDS, about
150 million have Hepatitis C. “Without
treatment, many often die of cirhossis
of the liver or liver cancer,” he
says. The Hepatitis C drugs are still in
clinical trials and Brown declines to
give more details about them.
Brown
says he’s happy to be in Richmond,
where Boehringer has had a presence
since 1976 as part of a venture with the
now-defunct drug maker A.H. Robbins. His
company’s expansion means there will
be plenty of work in the future.
The
park is growing as well. Brown notes
that just outside his window is the site
of the new $300 million Philip Morris
research facility that will greatly
expand the park by adding more than 500
jobs in about two years. With Philip
Morris helping anchor the park, even
more jobs are likely to be attracted.
Richmond
offers other benefits of a more
intangible nature, says Brown, who hails
from Idaho came to the area three years
ago. Prior to that, he worked for 17
years with Roche, the Swiss drug maker,
at a research facility in Boulder, Col.
The proximity to the Rocky Mountain ski
slopes was a big plus. But Boulder,
being a university town, fostered
political correct attitudes that made it
hard for Brown to admit at social events
that he worked for a chemical company.
“Here in Virginia, they understand
that this is a necessary undertaking.”
Boulder
was a long drive from any academic
center outside of Denver, Brown adds.
From Richmond, he can be in a variety of
scientific hotspots in a few hours.
What’s
more, living in the Richmond area is
less expensive than pricey Boulder and
leading drug-making areas such as
Boston, New Jersey and San Francisco. As
Brown notes, a number of major drug
companies are downsizing and
Richmond’s favorable cost of living
can be a pretty good insulation against
potential layoffs. The trend at
Richmond’s BioTechnology Research Park
is contrarian – adding jobs rather
than losing them.
--
August 26,
2005
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