* Drug cuts glycosylated haemoglobin after 24 weeks
* Dapagliflozin also hits secondary target
* Could be first of new type of diabetes drugs to market
* Jefferies analysts estimated peak sales at $1.5 bln
(Adds more analyst comment, shares)
By Sam Cage
VIENNA, Oct 2 An experimental diabetes drug from
Bristol-Myers Squibb (BMY.N) and AstraZeneca (AZN.L) met its
main target in a late-stage study, achieving significant
reductions in a marker for blood glucose levels.
When added to the common diabetes pill metformin,
dapagliflozin cut both levels of both glycosylated haemoglobin
-- an indication of glucose concentration in the blood -- and
fasting plasma glucose in patients with type 2 diabetes after 24
weeks, hitting both its main and secondary targets.
It is the first late-stage data on the once-daily pill
dapagliflozin, a member of a class of drugs known as SGLT2
inhibitors and designed to block reabsorption of glucose to
lower elevated blood sugar levels.
If approved, it could be the first such drug to reach the
market, and the companies have said they could file for approval
in late 2010 or early 2011.
In a note earlier this week, analysts at Jefferies estimated
peak sales at $1.5 billion but said they were cautious due to
potential safety issues, as the drug's mechanism puts pressure
on the kidney, and because of a lack of long-term data.
"We have not seen anything of concern," William Mezzanotte,
global product director at Astra, told Reuters. "We are
confident we can continue safely with this drug."
UBS analysts said on Friday the trial data was "greeted
warmly by doctors". AstraZeneca's shares were largely unmoved,
trading 0.9 percent lower on the day, broadly in line with the
market for European drug stocks .SXDP.
"Dapa's (dapagliflozin's) unprecedented efficacy offering
for an oral anti-diabetic agent -- with what we see as a
manageable safety profile -- puts it on a trajectory to be a
risk-adjusted global blockbuster," UBS said in a research note.
The data prompted UBS to increase their 2014 forecasts for
the drug to $705 million from $433 million.
The trial, results of which were presented at a European
Association for the Study of Diabetes (EASD) meeting in Vienna,
compared dapagliflozin plus metformin with placebo plus
An estimated 246 million people across the world have
diabetes. Most have type 2 diabetes, the kind linked to poor
diet and lack of exercise.
The study assessed results from 546 patients aged 18 to 77
who had type 2 diabetes that was inadequately controlled with
Astra agreed in January 2007 to help develop and sell
dapagliflozin and a second Bristol diabetes drug in a deal that
could bring the New York-based company more than $1 billion.
(Additional reporting by Kate Kelland in London, editing by
Hans Peters/Will Waterman)