AstraZeneca and B-MS see delay for dapagliflozin, as AZ posts 3rd-qtr 2011 results with generics taking a toll

27 October 2011

Just as Anglo-Swedish drug major AstraZeneca (LSE: AZN) was about to announce third-quarter 2011 financial results, last evening the company received disappointing news from the US Food and Drug Administration regarding its type 2 diabetes drug candidate dapagliflozin (under development with US partner Bristol-Myers Squibb; NYSE: BMY), with the agency extending the new Prescription Drug User Fee Act (PDUFA) goal date by three months to January 28, 2012.

In response to an FDA request for additional data on dapagliflozin, B-MS and AstraZeneca are submitting data from recently completed and ongoing Phase III clinical trials. This data submission constitutes a major amendment to the original New Drug Application for dapagliflozin, the companies noted.
Assuming the drug gets regulatory approval, dapagliflozin may earn $308 million in sales for Bristol-Myers and $144 million for AstraZeneca in 2015, according to the average estimates of two analysts compiled by Bloomberg.

AstraZeneca 3rd-qtr sales dip 2%

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