Johnson & Johnson - Index

Johnson & Johnson - report - Index

18
O U R C A R I N G T R A N S F O R M S :
The Threat of Infection
Tiko Kerr, a Canadian artist and
athlete, tested positive for HIV
in 1985. For years, drug therapy
kept the virus under some level
of control. At times, he was
forcing down 80 pills a day. By 2005,
however, every anti-HIV drug combination
that Tiko tried failed to help. His virus had
become resistant to all available therapy, a
common problem for HIV patients.
“When a virus replicates at a high rate, mutations occur
and the virus can become resistant,” explains Marie-Pierre de
Bethune, Vice President of Global Clinical Virology at Tibotec,
Inc., in Mechelen, Belgium.
De Bethune and others working
against the AIDS virus at Tibotec had
zeroed in on the problem of drug resistance
in the early 1990s. “Our challenge
was to find a way to shut off the replication
of the virus, as well as inhibit resistant
virus from developing,” she says.
Their research resulted in a number
of possibilities for new HIV medicines,
including INTELENCE ™ (etravirine)
tablets, a non-nucleoside reverse transcriptase
inhibitor (NNRTI) granted
accelerated approval from the U.S. Food
and Drug Administration in January
2008, and PREZISTA ™ (darunavir)*,
a protease inhibitor that received its
first U.S. approval in 2006 and is now
available in nearly 60 countries.
FIGHTING INFECTION Although neither INTELENCE ™ nor
PREZISTA ™ was approved in Canada at the time, Tiko’s physician
was able to start him on the medications as part of an anti-HIV
drug cocktail. Soon, Tiko’s viral load dropped 90 percent. It
continued to fall, and today remains at an undetectable level.
“MRSA is transmitted rapidly and is
highly resistant to many antibiotics.
We’re seeing it among hospital patients,
in the community, in schools—anyplace
where groups of people live together. It’s
a serious health issue,” says Karen Bush,
PhD., a Distinguished Research Fellow
and microbiologist at J&JPRD.
“Mine is just one patient’s story,” says Tiko, whose fight
continues. “I was given hope and have come back from the brink.”
ANTIBACTERIAL RESISTANCE Viruses like HIV/AIDS aren’t the
only kinds of infections where resistance poses a significant
worldwide public health threat. In 2007 news coverage focused
on “superbugs,” including methicillin-resistant Staphylococcus
aureus (MRSA), and the threat of resistant bacteria—tiny life
forms that have mutated to the point where many antibiotics
are useless against them.
“The need for new treatments has reached a critical
point,” says Karen Grosser, Ph.D., Therapeutic Area Head,
Anti-Infectives, Johnson & Johnson Pharmaceutical
Research & Development, LLC (J&JPRD). “We have
submitted filings in the U.S., Europe and other countries for
a compound, ceftobiprole—an investigational broad-spectrum
cephalosporin—which has the ability to kill a broad range
of serious bacteria, including MRSA. We’ve also launched a
potent new drug in the U.S., DORIBAX ™
(doripenem for injection), and have
submitted filings for its approval in
Europe and other countries.”
In October 2007, the U.S. Food and
Drug Administration approved DORIBAX ™
as a new treatment for complicated intraabdominal
and urinary-tract infections,
including kidney infection (pyelonephritis).
In clinical studies, DORIBAX ™
was shown to be effective against a broad
range of bacteria responsible for these
serious infections, including Pseudomonas
aeruposa, a difficult-to-treat gram-negative
organism. Other indications, such as
hospital-acquired pneumonia, are under
regulatory review in the U.S. and Europe
(see page 27).
“Resistance is a public health
problem that is not going to go away,” says John Otero, Global
Marketing Leader for Anti-Infectives, Pharmaceutical Group
Strategic Marketing. “Our vision is to continue to be a leader in
anti-infective drug development and to continue to introduce
new and more powerful weapons to fight bacteria.”
*PREZISTA™ co-administered with 100 mg ritonavir and with other antiretroviral agents is currently indicated for the treatment of human immunodeficiency virus
(HIV) infection in antiretroviral treatment–experienced adult patients, such as those with HIV-1 strains resistant to more than one protease inhibitor. INTELENCE™,
formerly known as TMC125, is the first non-nucleoside reverse transcriptase inhibitor (NNRTI) to show antiviral activity in treatment-experienced adult patients
with NNRTI-resistant virus.
B A C K F R O M T H E B R I N K New therapies provide the hope needed for Tiko Kerr (opposite) to continue
his fight against HIV. He says his two-hour workout sessions at the Vancouver Rowing Club “give me strength and
spiritual balance, and recharge my creativity as an artist. I feel like I’ve been given another chance.”
J O H N S O N & J O H N S O N 2 0 0 7 A N N U A L R E P O R T