UPDATE 2-BMS, Astra's new diabetes drug hits study target

Fri Oct 2, 2009 7:11am EDT

* 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 (Reuters) - 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 metformin.

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 metformin alone.

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. [ID:nN08476732] (Additional reporting by Kate Kelland in London, editing by Hans Peters/Will Waterman)