Lilly shares jumped as much as 9 percent after data from the trial
was released Thursday at a medical meeting in Stockholm.
"This is the first diabetes therapy to show robust effect in
reducing cardiovascular death. It really is big news," said Dr.
Bernard Zinman, director of the Diabetes Centre at Mount Sinai
Hospital in Toronto, who led the three-year study of 7,000 people.
Because about one-half of the deaths in people with type 2 diabetes
are caused by cardiovascular disease, reducing cardiovascular risk
is considered essential to diabetes care. Type 2 diabetes is the
most common form of the disease and is linked to obesity.
Jardiance, a once-a-day pill which won U.S. approval last year,
belongs to a new family of treatments called SGLT2 inhibitors that
include Johnson & Johnson's Invokana and AstraZeneca Plc's Farxiga.
They lower blood sugar by inhibiting reabsorption of glucose in the
kidneys.
Jardiance was developed jointly with Germany's privately held
Boehringer Ingelheim.
Zinman, in an interview, predicted the new study would prompt
medical societies to recommend that Jardiance be used by type 2
diabetics who have a history of heart disease or who are at risk of
cardiovascular events.
About 26 million Americans have type 2 diabetes, according to
federal data for 2014. The vast majority of those patients could be
candidates for Jardiance, which costs over $4,000 per year,
Morningstar analyst Damien Conover said.
"The big news here is that the drug reduced cardiovascular stuff.
That has not been the case with all things in diabetes," said David
Marrero, president of health care and education at the American
Diabetes Association. "It is probably going to be a more popular
drug because of that."
JARDIANCE COULD BOOST EARNINGS
Sanford Bernstein analyst Tim Anderson more than tripled his annual
sales forecast for Jardiance and combination drugs containing it to
$2.7 billion by 2020. He cut his 2020 sales forecast for Merck & Co
Inc's Januvia, the leading member of a competing class of oral
diabetes drugs called DPP-4 inhibitors, to $6 billion from $7.8
billion.
Anderson estimates Jardiance could boost Lilly's earnings per share
by 8 percent on average across 2016 to 2020.
In the study, patients taking Jardiance had a 38 percent reduction
in cardiovascular death, including from heart attacks and strokes.
There was no significant difference in non-fatal heart attacks or
non-fatal strokes.
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Those taking Jardiance had a 32 percent lower risk of dying from any
cause, and a 35 percent lower rate of hospitalizations from heart
failure.
The benefits were especially impressive because they added to
protection that patients received from taking cholesterol fighters
and other life-saving heart drugs, Zinman said.
"This is a wonderful thing," said Dr. Jerome Tolbert of Mount Sinai
Beth Israel Hospital in New York. He has not prescribed Jardiance
and similar drugs as frequently as treatments like Januvia, but
expects that may change based on the new data.
Zinman noted that Jardiance, like other SGLT2 drugs, causes weight
loss and reduced blood pressure, besides lowering both blood sugar
levels and body fat, and also reduces swelling, which all help the
cardiovascular system.
Lilly and Boehringer last month disclosed that Jardiance met its
primary study goal, becoming the first diabetes drug to show
heart-protective results in a large cardiovascular trial. But they
did not unveil detailed data until Thursday at the medical meeting.
Shares of Lily closed up 6.5 percent at $89.98 on Thursday, after
rising as high as $92.83.
In calculating the combined number of cardiac deaths, non-fatal
heart attacks and non-fatal strokes, 14 percent fewer events were
seen in patients taking Jardiance in combination with standard
treatments, compared with patients who took standard treatments
alone, meeting the study's main goal.
Standard treatments included statins, which lower cholesterol, and
blood pressure drugs.
(Reporting by Ransdell Pierson in New York; Additional reporting by
Deena Beasley in Los Angeles; Editing by Michele Gershberg, Jeffrey
Benkoe and Lisa Shumaker)
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