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 Semaglutide is the third diabetes drug to show such heart benefits,
after Novo's Victoza injectable and Eli Lilly and Boehringer
Ingelheim's Jardiance pill.
Novo is already planning a longer study of semaglutide similar to
Leader, specifically aimed toward getting a label-claim, Novo's
chief science officer Mads Krogsgaard told Reuters, referring to
Novo's 9,000 patient Victoza study, which lasted five years.
"The idea is to launch the study the moment semaglutide gets
approved," Krogsgaard said.
Semaglutide, which has proved highly effective in reducing glucose
levels in patients with type II diabetes, is viewed as a pivotal
product for Novo, which competes in the GLP-1 market against several
rivals including Eli Lilly's Trulicity.
"This is a molecule which Novo will examine from every possible
angle, also in regards to new disease areas such as liver
complications and obesity," Krogsgaard told Reuters.
Novo's so-called SUSTAIN 6 study, presented on Friday, showed that
semaglutide significantly reduced the risk of heart complications in
patients.
Because about half of the deaths in people with diabetes are caused
by heart disease, reducing the risk such as heart attacks and
strokes is seen as essential.
Novo announced in April that the SUSTAIN 6 trial had significantly
cut the risk of major adverse cardiovascular events, but the scale
of the benefit was only disclosed this week at a meeting of diabetes
experts in Munich.
The study presented of Friday also found that semaglutide caused an
"unexpected higher rate" of retinopathy complications, such as
blindness.
"But depending on the cause, a large study might "wash away" this
effect and maybe even show an improvement", Krogsgaard said.
Semaglutide, which is designed to be given once a week, belongs to a
class of medicines known as GLP-1 analogues that increase the body's
insulin production when blood sugar levels are raised.
The excessive blood sugar levels that come with diabetes can cause
long-term damage to blood vessels, increasing the risk of heart
attack, heart failure or stroke.
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Novo intends to file for regulatory approval of semaglutide in the
United States and Europe in the final quarter of 2016. Consensus
analyst forecasts suggest annual sales could reach $2.2 billion in
2022.
Jefferies predicted an approval decision on semaglutide in the
second half of 2017.
Novo Nordisk, which in September presented a new CEO to take over by
the beginning of next year, is facing headwinds in the United
States, its biggest market, due to tough competition and pricing
pressure.
"We expect investor confidence to rise and over time switch away
from the current risks of insulin pricing," Deutsche Bank wrote in a
note to clients, predicting instead a new focus on the expansion of
the GLP-1 market.
"Semaglutide is one of the drugs which is going to drive growth for
Novo Nordisk in the coming years - their entire GLP-1 business in
fact," said Sydbank analyst Soren Lontoft.
The Danish company is also working on an oral version of semaglutide,
which would be the first GLP-1 to be given as a pill rather than an
injection.
Shares in Novo Nordisk were up 1.9 percent at 310.50 crowns by 0730
GMT.
(Editing by Greg Mahlich and Jason Neely)
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