| June 14
June 14 Diabetes patients stand to benefit from
two experimental insulin therapies that could eventually replace
Sanofi's global leader Lantus, according to results
from large clinical trials released on Saturday.
Sanofi's experimental new drug Toujeo is being positioned to
succeed Lantus, whose annual sales approach $8 billion, when it
loses patent protection early next year. Eli Lilly and Co
is gearing up to sell a copycat version of Lantus, which
industry analysts say could bring in up to $600 million a year
Both treatments are basal insulins, which help diabetics
keep blood sugar levels under control between meals and
throughout the day.
Late-stage studies of Toujeo showed that patients with type
2 diabetes were 31 percent less likely at nighttime to have
potentially dangerous declines in blood sugar than those taking
Lantus, the world's most prescribed insulin, researchers said on
Such episodes of hypoglycemia, in which patients can faint
or lose consciousness, are the most feared side effect of
"Low blood sugar events, especially at night, are a big deal
because they are frightening and are a barrier to use of
insulin," Dr. Geremia Bolli, a professor at the University of
Perugia, Italy, who helped lead one of the studies, said in a
telephone interview. He presented his findings at the American
Diabetes Association meeting in San Francisco.
More than 370 million people worldwide have diabetes, with
up to 95 percent of them having type 2, a condition often
triggered by obesity, according to the International Diabetes
Federation. The disease raises the risk of numerous serious
Toujeo has the same active ingredient as Lantus, called
insulin glargine, but in a three-fold higher concentration,
Bolli said. Its activity level does not jump overnight, as is
the case with Lantus.
The hypoglycemia data came from a combined review of three
Phase III studies sponsored by Sanofi. The studies also showed
that Toujeo and Lantus were similarly effective in controlling
overall blood sugar and are the basis for Sanofi's recently
filed U.S. marketing application for Toujeo.
The new drug is also awaiting approval in Europe.
In a fourth late-stage study involving patients with type 1
diabetes - the less common, inherited form of the disease -
rates of hypoglycemia and overall blood sugar control were
similar for Toujeo and Lantus.
LILLY'S LANTUS COPYCAT
While France's Sanofi develops the successor to its cash
cow, a potential rival from U.S. drugmaker Eli Lilly proved just
as effective and safe as Lantus for patients with type 1 and
type 2 diabetes, including similar incidence of hypoglycemia.
Results for the Lilly drug, which has the same molecular
formula as Lantus, were based on six studies sponsored by Lilly
and its partner Boehringer Ingelheim.
"Completed clinical trials for this new insulin glargine
product show that it works similarly in the body and produces
clinical results similar to Lantus," said Dr. Tom Blevins of
Texas Diabetes & Endocrinology in Austin, Texas, who helped lead
Wall Street is expecting the copycat, called LY2963016, to
be priced significantly lower than Lantus, in order to attract
patients once Lantus loses patent protection.
Although awaiting approval in the United States, Europe and
Japan, its U.S. launch could be delayed until mid-2016 by an
ongoing patent dispute with Sanofi.
Lilly said the drug will not be designated a biosimilar, or
biotech generic, in the United States, which does not yet have
legislation regulating copycats of such drugs. Instead, it will
be marketed as a branded medicine.
Lilly is also developing its own new basal insulin, called
peglispro, which in clinical trial results released earlier this
year, proved more effective than Lantus in reducing blood sugar
levels for patients with type 2 diabetes. It also caused
significantly fewer episodes of overnight hypoglycemia.
Lilly expects to seek U.S. and European approvals early next
year for the drug. But patients taking peglispro had seriously
elevated liver enzymes, a sign of potential liver toxicity,
which could give Toujeo an advantage.
(Aadditional reporting by Bill Berkrot in New York and Natalie
Huet in Paris; Editing by Michele Gershberg, Bernard Orr)