New rules raise stakes for Lilly drug

July 21, 2010

Drugmakers—including Eli Lilly and Co.—testing experimental Alzheimer’s medicines got good news last week when the National Institute on Aging and the Alzheimer’s Association proposed new guidelines to make earlier diagnoses of the disease.

If adopted, those guidelines—along with new forms of testing for Alzheimer’s—are expected to triple the prevalence of the disease, which now stands at 5.3 million Americans, according to the Deloitte Center for Health Solutions.

That’s great if you’re trying to sell a product to that market, as drugmakers are clamoring to do. They have more than 100 experimental Alzheimer’s medicines in human testing right now, according to The New York Times.

Lilly can claim four of those, including two in Phase 3 clinical trials, the last stage before seeking market approval from the U.S. Food and Drug Administration.Those late-stage drugs attempt to block or reduce levels of protein plaques in the brain, called amyloid beta, which are thought to cause the telltale memory loss of Alzheimer’s.

But there is a problem, the Times noted in a July 16 story. The FDA says it needs to know not just that a drug reduced or even eliminated amyloid plaque, but also that patients taking the drug experienced better memory and clearer thinking. But with a slow-progressing disease like Alzheimer’s, the time it would take to document such changes could make testing too expensive for drug companies.

That’s especially the case for Lilly, which is hoping a breakthrough Alzheimer’s drug might produce the kind of blockbuster sales it needs to offset the loss of revenue from its antispychotic drug Zyprexa, which will lose its protection against cheap generic copies in October 2011.

Current medicines give only temporary relief of the symptoms of Alzheimer's, but do not appear to slow progression of the disease. That's why, even before the new recommended guidelines were announced, Barcalys Capital analyst Tony Butler predicted an Alzheimer’s drug that actually prevents or reverses the disease could fetch sales of $5 billion a year, according to Bloomberg News.

That’s roughly the amount of revenue Lilly stands to lose from its schizophrenia drug Zyprexa—and the company has few other drug candidates near enough to market approval to fill in that looming revenue gap.

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