November 22, 2006

Europe OKs popular Lilly diabetes drug

Approval for injectable Byetta is the first for use outside U.S.

By John Russell john.russell@indystar.com

Eli Lilly and Co.'s new diabetes drug Byetta, which became so popular that the company had trouble meeting demand this summer, is about to go international.

The drug, noted for its weight-loss benefits, has been approved for sale in 27 European countries, Lilly said Tuesday. It's the first market outside the United States for the drug, which Lilly is counting on to become a key future source of revenue.

Lilly co-developed Byetta with Amylin Pharmaceuticals, a San Diego-based company.

Byetta is given to diabetic patients to help control their blood-sugar levels before they become insulin-dependent. Many patients and diabetic advocacy groups report that people who take Byetta often lose weight, in contrast with some other diabetes drugs, which often cause weight gain.

"The word-of-mouth feedback has been remarkably positive, more so than any diabetes drug I can remember being launched," said Kelly L. Close, principal of the San Francisco diabetes and obesity-consulting firm Close Concerns.

Sales of Byetta have mushroomed since the drug was launched in June 2005. In the third quarter, sales were $126.4 million, up 28 percent from the previous quarter, putting it on a growth trajectory to become one of Lilly's major products, said Dave Vondle, Lilly's global brand development team leader for Byetta.

Currently, Byetta is still far behind such Lilly blockbusters as schizophrenia drug Zyprexa, which rang up $1.1 billion in the third quarter; cancer drug Gemzar ($355 million); antidepressant drug Cymbalta ($349 million); or osteoporosis drug Evista ($258 million).

"What makes Byetta different is that patients are asking for the drug," said David Kliff, publisher of Diabetic Investor, a Chicago newsletter for investors in diabetes companies. "I think it has an outstanding future."

So many patients were taking the drug that Lilly and Amylin ran into a shortage of injection-pen cartridges this summer, and asked doctors to hold off on putting new patients on the drug for several months.

Jim Reddoch, an analyst with Friedman Billings Ramsey & Co. in Arlington, Va., expects Byetta to hit at least $2 billion in annual sales by 2011, he wrote in a recent report.

Lilly plans a phased launch of Byetta in Europe starting in mid-2007, to give the company time to handle logistical issues.

Lilly co-markets the drug in the United States with Amylin, sharing the revenue evenly. But in Europe, Lilly will market the drug alone and book all the revenue, paying Amylin a royalty.

Call Star reporter John Russell at (317) 444-6283.

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