The success of the oral form of the drug, known generically as
semaglutide, in the Phase III trial is a boost for a medicine seen
as important for ensuring the group's long-term growth in a highly
competitive diabetes market.
While the overall positive result announced late on Tuesday was
largely as expected, some investors focused on the fact that the
difference in weight loss after 26 weeks between oral semaglutide
and Jardiance was not statistically significant.
Novo Nordisk's shares, which are down about 16 percent from a
January peak, traded around 1.2 percent lower in early dealings on
Wednesday, underperforming the broader European stock market.
Still, analysts at Deutsche Bank said they remained upbeat for the
product.
"Oral semaglutide increasingly appears to be on its way to become a
major blockbuster," they wrote in a note. "We believe this news
should come as expected to most investors, a relief to some and a
source of controversy to a few."
The once-daily pill, which Novo hopes to launch in 2020, belongs to
a blockbuster class of treatments known as GLP-1s that stimulate
insulin production. So far, all have been injections and a pill
would offer a step-change in convenience.
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Novo said the trial achieved its primary objective "by demonstrating
a statistically significant and superior improvement" in glycated
hemoglobin, an indicator of blood glucose levels, with oral
semaglutide compared to Jardiance.
Mads Krogsgaard Thomsen, Novo's chief science officer, said the
positive results from the so-called PIONEER 2 trial were "an
important milestone" in the clinical development of oral semaglutide.
Novo expects to provide data from the remaining eight trials this
year and expects to submit the drug for regulatory approval in 2019,
ahead of the drug's potential 2020 launch.
(Reporting by Ben Hirschler and Jacob Gronholt-Pedersen; Editing by
Mark Heinrich and Alexander Smith)
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