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[IP] Bristol-Myers' pioneering diabetes drug bests rivals in 2-year study



Bristol-Myers' pioneering diabetes drug bests rivals in 2-year study
June 27, 2011 - 9:45am ET | By John Carroll 

With an FDA advisory committee meeting looming next month, Bristol-Myers
Squibb and AstraZeneca posted new two-year data on their diabetes drug
dapagliflozin, underscoring its potential as a whole new way to lower blood
sugar in patients. But several of the reports covering the data quickly
highlighted 18 cases of cancer found among patients taking the drug.

Dapagliflozin is an SGLT-2 inhibitor, which is designed to spur the body to
purge excess blood sugar in urine. A number of companies, including Eli
Lilly, J&J and Boehringer are all pursuing a similar pathway. But among the
more than 5,000 patients who took the new drug from BMS/AstraZeneca, 18
developed breast and bladder cancer compared to only two cases in the
control arm. And with malignancy and heart risks linked to currently used
standards, the new safety data helped to raise the alarm about the cancer
numbers.

Statistically, however, the overall number of cancers was so low that the
drug arm and control arm reflected little comparable risk associated with
the therapeutic. And that left analysts ready to shrug off the cancer as
more anecdotal, unlikely to sway the vote but possibly increasing the
chances of a post-marketing safety study requirement for the manufacturers.

"No doubt they'll bring this up at the advisory committee," ISI's Mark
Schoenebaum told Bloomberg. "But I'd be very surprised if this blocked
approval." Researchers also noted that there were no signs of added cancer
risk in preclinical animal studies designed to focus on that issue quite
closely. Thomson Pharma has estimated potential 2015 sales of $631 million.

This morning BMS also posted new Phase III data showing that dapagliflozin
plus metformin XR significantly reduced blood sugar levels compared to
dapagliflozin or metformin XR alone plus placebo.

"As we advance our knowledge of how SGLT2 inhibitors may work as a potential
treatment for patients with type 2 diabetes, long-term data become critical
to assess a compound's safety and its ability to sustain glycemic control,"
said Michael A. Nauck, MD, the principal investigator of the study. "These
two-year data demonstrated that patients taking dapagliflozin added to
metformin sustained reductions in blood sugar levels over an extended period
of time."
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