By Bill Berkrot
Feb 25 An experimental once-weekly medicine for
type 2 diabetes developed by Eli Lilly and Co proved as
effective in lowering blood sugar as Victoza from Danish
drugmaker Novo Nordisk in an eagerly anticipated late
The Lilly drug, dulaglutide, achieved the primary goal of
the 599-patient study by demonstrating so-called non-inferiority
to the highest approved dose of Victoza after 26 weeks,
according to initial results released by the company on Tuesday.
Lilly shares rose more than 1 percent before retreating.
Dulaglutide, considered one of the more important medicines
in Lilly's pipeline of drugs in development, is awaiting U.S.
and European approval decisions.
"It is our hope that we will have approval this year,"
Lilly's Senior Medical Director Sherry Martin said in a
Once weekly dulaglutide and Victoza, which is taken daily
and known chemically as liraglutide, belong to a class of
injected diabetes drugs called GLP-1 receptor agonists. They
work by increasing the release of insulin after meals and by
slowing absorption of food in the gastrointestinal tract.
"Dulaglutide is the only GLP-1 agonist to show
non-inferiority against liraglutide's highest-approved dose in a
Phase III trial," Enrique Conterno, president of Lilly Diabetes,
said in a statement.
BMO Capital Markets analyst Alex Arfaei noted that the other
weekly diabetes drug from the class did not fare as well in a
"The positive surprise here is that so far dulaglutide had
shown a similar clinical profile to competitor Bydureon in terms
of A1C (blood glucose) lowering and Bydureon failed to show
non-inferiority versus Victoza," he said, referring to
AstraZeneca's weekly diabetes treatment from the same
John Boris, an analyst with Suntrust Robinson Humphrey,
raised his sales forecast for dulaglutide to $1.6 billion by
2020 from $1.1 billion following the non-inferiority result.
He believes Lilly will be able to undercut Novo's Victoza
pricing with payors since the study used a lower dose - 1.5
milligrams versus 1.8mg for Victoza - and that the weekly dosing
will give it an additional competitive advantage.
"Those are two powerful tools," said Boris, who sees the
GLP-1 market growing to $5 billion by 2020.
Victoza, which now owns about 70 percent of the market for
GLP-1 drugs, had sales of more than $590 million in the fourth
quarter, putting it on track to exceed $2 billion this year.
Dulaglutide in previous studies proved superior in reducing
blood sugar compared with placebo and a variety of other
diabetes treatments. But analysts had been especially anxious to
see how it would fare against future main rival Victoza.
DETAILS LATER THIS YEAR
Patients in the Award-6 trial were already taking metformin,
the most commonly prescribed initial treatment for type 2
Details of the study, such as the exact magnitude of glucose
reduction, the percentage of patients who reached blood sugar
target levels and amount of weight loss seen with each drug,
will be presented at a medical meeting later this year.
Side effects were similar for patients in both treatment
groups, with the most frequently reported adverse events
gastrointestinal-related, such as nausea, the company said.
"There are no new safety signals," Martin said.
The potential market for type 2 diabetes drugs is enormous
and growing. An estimated 382 million people worldwide have
diabetes, according to the International Diabetes Federation,
with type 2, which is often associated with obesity, accounting
for 90 percent to 95 percent of all cases.
Eli Lilly shares were up 47 cents, or 0.8 percent, at $58.50
on the New York Stock Exchange after earlier climbing as high as