Johnson and Johnson 2006 Annual Report Download - page 20

J O H N S O N & J O H N S O N 2 0 0 6 A N N U A L R E P O R T
says that the team “engineered against failure” by creating
a timeline that gave specific details for each research and
development function on a day-to-day—and, eventually,
hour-to-hour—basis: “We covered the walls of the Tibotec
facility in Mechelen, Belgium, with posters six feet long
and three feet wide. The posters illustrated the interplay of
functions and deliverables, and were a constant reminder
of deadlines and commitments.”
Another original team member, Marie-Pierre de Bethune,
Vice President of Clinical Virology, says: “Our motto was ‘The
patients are waiting.’ It drove us to work in a way that Paul
called ‘faster than possible,’ without compromising on quality,
science or ethics. We made many personal sacrifices to meet a
highly accelerated timeline. For instance, during high-output
months, we restricted vacation times. And when it came time
to work on the application for health authorities, the core team
went off-site to a remote location in northeast Belgium for an
entire week, working from 7 a.m. to 11 p.m. each day.”
The discipline paid off. Only five
years elapsed between the first study
in humans (January 2001) and the
submission of filings (December 2005).
Says Stoffels: “In drug-development
terms, this is an extremely short time.”
A DEEP CO M M I TME N T TO HIV
In addition to PREZISTA™, which was
known as TMC114 throughout the
development process, Tibotec has two
other novel antiretrovirals—TMC125
and TMC278—in development. Both
investigational drugs are NNRTIs—
non-nucleoside reverse transcriptase
inhibitors.
TMC125, in late-stage develop-
ment, is the first investigational
NNRTI to show significant activity
in patients with prior NNRTI failure.
Clinical trials are also being conducted
to investigate its use in combination
with PREZISTA™. TMC278, an early
development compound, is highly
potent and, if successful, could become
the backbone for fixed-dose
combination therapy in a single pill.
The company continues to create
its own path in the world of HIV.
Another NNRTI compound, TMC120,
was licensed by the company to
the International Partnership for
Microbicides, a nonprofit product
development partnership, for develop-
ment as a vaginal microbicide. This
agreement, signed in 2004, was the first
royalty-free licensing arrangement of
its kind in microbicide research and
is an approach that has since been
repeated by other manufacturers.
HIV IN WO M E N : A SPEC I A L S T U DY On the research front,
Tibotec Therapeutics—the company’s U.S. marketing,
sales and clinical arm—initiated in 2006 the largest clinical
study ever conducted among treatment-experienced adult
women with HIV. The GRACE (Gender, Race and Clinical
Experience) study is comparing gender differences in the
efficacy, safety and tolerability of PREZISTA™ administered
with other antiretroviral agents over a 48-week treatment
period. The study, which is being conducted at sites
throughout the U.S., Mexico and Canada, also explores racial
differences in treatment outcomes.
Says McHugh: “Although women represent nearly 50
percent of all infections worldwide, they are vastly under-
represented in HIV clinical trials—even though research to
date not only suggests that women may tolerate HIV medica-
tions in different ways than men but also suggests that certain
complications of the disease may be gender-specific.
We’ve worked very closely with the U.S. HIV community in
G LO B A L H E A LT H “Infectious diseases represent our greatest unmet
medical challenges,” says Julie McHugh, Company Group Chairman,
Virology. Adds Roger Pomerantz, M.D., FACP, President, Tibotec Research
and Development: “Our new compound, PREZISTA™, ‘fits’ HIV neatly,
making it extremely difficult for the virus to mutate.”
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