Recently, Bristol-Myers Squibb Company (BMY) announced that the US Food and Drug Administration (FDA) has accepted the new drug application (NDA) for its diabetes candidate dapagliflozin.
Dapagliflozin has been co-developed with AstraZeneca (AZN). The application, seeking US approval of the candidate for treating adults suffering from type II diabetes, was filed in December 2010. A response from the US regulatory body is expected to be out in the final quarter of 2011 (target date: October 28, 2011).
The candidate is under review in Europe for the same indication. An application seeking marketing approval in Europe was also filed in December 2010. The European Medicines Agency validated the application in January this year.
The applications, both in the US and Europe, were based on data (up to two years) from a global development program. The program comprised 40 studies and evaluated approximately 6,000 patients. We believe that if dapagliflozin is cleared by the regulatory authorities then the top line at Bristol- Myers would be boosted significantly as it would target a highly lucrative diabetes market.
The incidence of diabetes is on the rise. Approximately, 438 million people are expected to be affected by diabetes by 2030. Type II diabetes accounts for the majority of diabetes cases. The type II diabetes market, which has players such as Merck & Co. (MRK) and Novo Nordisk (NVO), is expected to be worth $33.7 billion by 2016.
Our Recommendation
We currently have a Neutral recommendation on Bristol-Myers, which is supported by a Zacks #3 Rank (short-term Hold rating).
ASTRAZENECA PLC (AZN): Free Stock Analysis Report
BRISTOL-MYERS (BMY): Free Stock Analysis Report
MERCK & CO INC (MRK): Free Stock Analysis Report
NOVO-NORDISK AS (NVO): Free Stock Analysis Report
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