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Lilly confident of FDA approval for Amyvid, Lechleiter says

March 9, 2011

Eli Lilly and Co. CEO John Lechleiter said he’s confident of gaining U.S. regulatory approval for a drug to help identify plaque in the brain associated with Alzheimer’s disease.

Outside advisers to the Food and Drug Administration voted in January against immediate approval of the medicine, Amyvid, unless the Indianapolis-based drugmaker establishes a training program and a way to ensure that results of brain scans are read consistently. Lilly aims to resolve the FDA panel’s concerns in a few months, Lechleiter said in an interview in Tokyo on Wednesday.

“We are confident that we can work with the FDA and gain approval,” said Lechleiter, 57. “This is an imaging agent that we’ve used in our own clinical studies, so we are very familiar with it.”

Amyvid’s clearance by the FDA would vindicate Lilly’s $300 million purchase of the drug’s discoverer, closely held Avid Radiopharmaceuticals, in December. The acquisition hasn’t been viewed by investors as important to Lilly’s broader focus on replacing top products before they face competition from cheaper generic versions.

Lechleiter has struggled to get new drugs on the market before patents expire in the next three years on products responsible for 65 percent of revenue.

Sales growth this year will be “in the low single digit,” Lechleiter said Wednesday. In January, the company predicted total revenue growth in 2011 would be “be flat to slightly increasing.”

Lilly rose 32 cents, or 0.9 percent, to $34.98 at the 4 p.m. close in New York Stock Exchange composite trading Tuesday. The stock has fallen 0.2 percent in the past year.

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