FDA demands more tests on new Lilly diabetes drug

Eli Lilly and Co. will have to wait at least 18 months and conduct more studies before it wins market approval of a once-weekly version of diabetes drug Byetta.

The drug, Bydureon, is key for Lilly because competitors are introducing their own daily versions of Byetta, a biotech drug that has helped diabetics control their blood sugar and, for some, lose weight.

The U.S. Food and Drug Administration on Tuesday told Lilly and its partners on Bydureon that they want to see results from two more clinical trials before rendering a decision on the drug. One of those studies is already under way, studying the formulation of the drug made in commercial-sized batches. The other study, not yet started, would measure how patients break down Bydureon when given higher than normal doses.

Lilly has been developing Bydureon with California-based Amylin Pharmaceuticals Inc. and Massachusetts-based Alkermes Inc. Bydureon is taken by injection once a week compared with Byetta's twice-daily injections.

Last year, Byetta pulled in nearly $797 million in sales around the world. Lilly split that revenue with Amylin, hauling in nearly $449 million. Wall Street analysts expect Bydureon, if approved, to sell even better, with some analysts even predicting the drug could pull in $1 billion a year.

Many analysts were expecting Bydureon to start contributing revenue for Lilly this year. Now, Lilly and its partners said they hope to complete the new studies and submit data to the FDA by the end of 2011. They expect the FDA to take another six months to render a decision again.

It’s the latest setback for Lilly in its efforts to bring new drugs to market before patent expirations on Zyprexa a year from now and Cymbalta in 2013 promise to wipe out most of those two drugs’ $8 billion in annual sales. Lilly also faces patent expirations on three other drugs between now and 2014.

The FDA asked for more information in March and pushed back its decision date back to October 22. It informed Lilly and its partners of the latest delay in a "complete response letter" sent to the companies.

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