Astra's Diabetes Drug Hurdles May Aid Competitors

News that the U.S. FDA did not approve Bristol-Myers Squibb and AstraZeneca's new diabetes drug could sour prospects for competing products

Karen Andersen, CFA 21 July, 2011 | 11:39AM
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An FDA advisory committee voted against recommending the approval of Bristol-Myers Squibb (BMY) and AstraZeneca's (AZN) diabetes drug candidate dapagliflozin, citing potential liver and cancer-related risks. We don't expect the drug will be approved on schedule in the U.S. in October, but we think dapagliflozin still stands a chance at approval in Europe. This news does not have a significant impact on our fair value estimates for either firm.

The drug is the first in a new class of drugs known as SGLT2 inhibitors, and we think this news could sour prospects for Johnson & Johnson's (JNJ) canagliflozin and Lilly's (LLY) BI10773 as well as Big Pharma's interest in signing a partnership with Lexicon (LXRX) for its own similar drug candidate, LX4211, in the near term.

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Karen Andersen, CFA  Karen Andersen, CFA, is a senior stock analyst with Morningstar.

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