Johnson Johnson (JNJ) has turned one of
diabetes’ most worrisome warning signs into a treatment that
lowers dangerously high levels of blood-sugar before the disease
can cause blindness, kidney damage and heart disease.
The demand for novel diabetes drugs is soaring as rising
obesity rates push the condition to epidemic levels, affecting
nearly 347 million people worldwide. While 10 different types of
drugs are sold to treat diabetes, physicians still struggle to
control their patients’ blood-sugar levels.
The spotlight is now on JJ’s canagliflozin, which is
designed to expel excess sugar from the body, something that
doesn’t normally occur until after glucose rises to critical
levels. The pill may reach pharmacies next year, competing with
Merck Co.’s $3.3 billion market leader Januvia.
While it’s not a cure, the approach “is a beautiful
example” of treating a serious disease by managing blood sugar
levels in a new way, said Laurence Kennedy, a specialist at the
Cleveland Clinic in Ohio, who hasn’t been involved in
researching the therapy, in a telephone interview.
Data on canagliflozin, to be reported at the American
Diabetes Association meeting this weekend, shows the pill
regulates blood sugar levels better than Januvia, according to
Derrick Sung, a Sanford C. Bernstein Co. analyst in New York.
Diabetes occurs when the body is unable to properly use or
produce enough of the hormone insulin to convert blood sugar
into energy. Most medicines for the illness, including Januvia,
work by manipulating insulin production to control glucose
The novel strategy developed by JJ sheds sugar through the
urine, after it’s filtered from the blood by the kidneys and
before it can be reabsorbed into the body.
The New Brunswick, New Jersey-based drugmaker plans to
unveil data from trials done in the final stages of testing
normally needed for U.S. marketing approval during the diabetes
meeting in Philadelphia. Last week, the company filed for
regulatory clearance to sell the pill in the U.S.
Still, the drug has drawn skepticism from some physicians,
and concerns about possible unknown risks. As a result, Larry Biegelsen, an analyst at Wells Fargo Securities in New York,
estimates the drug’s sales may be limited to $122 million in
2013, growing to $667 million in 2016.
“Using a side effect of uncontrolled diabetes as a primary
mode of treatment is unconventional, to say the least,” said
Adrian Vella, an endocrinologist at the Mayo Clinic in
Rochester, Minnesota, by telephone. “We still need to
understand how severe and how frequent the potential side
effects associated with these medications are.”
JJ gained less than 1 percent to $62.98 at the close in
New York. The shares have declined 4.8 percent in the past 12
Many diabetics also have kidney disease, and it’s not clear
if the drug’s action may further damage those organs over a
longer time period.
The most unusual side effect thus far stems from having a
urinary tract that is constantly flooded with excreted glucose.
As many as 20 percent of women given canagliflozin develop
fungal or bacterial genital infections, said Biegelsen.
The FDA has been tough on diabetes drugs since Avandia,
from London-based GlaxoSmithKline Plc (GSK), was linked to heart
attacks in 2007, and subsequent studies showed blood sugar
control medicines may have harmful effects. Dapagliflozin, a
drug from New York-based Bristol-Myers Squibb Co. (BMY) and London-
based AstraZeneca Plc (AZN) that works the same way as the JJ drug,
failed to win U.S. approval because of concerns about bladder
and breast cancer.
The data on JJ’s drug shows no signs of cancer, Biegelsen
wrote in a May 31 note to investors.
Diabetes drugs that have been approved were the third
fastest growing medications in the U.S. last year, with sales
rising 10.7 percent to $19.6 billion, led by Januvia, according
to IMS Health, a Norwalk, Connecticut-based health-care
information and services.
One “welcome benefit” of the JJ therapy is that early
results showed it doesn’t lead to low blood sugar when used
alone, said Tom Donner, director of the diabetes center at Johns
Hopkins University School of Medicine in Baltimore, who wasn’t
involved in the research.
Still, the risk of urinary tract infections, and the
resultant frequent trips to the bathroom, with the JJ therapy
could prove to be a hurdle, said the Mayo Clinic’s Vella.
“To me or you it might be a nuisance factor, but to
someone who is unstable on their legs, or might not be mobile,
getting up repeatedly at night might be a problem,” he said,
suggesting it will be key to whether the drug is used by
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