Health Care and Eli Lilly and Co. and Clinical Trials and FDA and Alzheimer's disease and Drug discovery and Health Care & Life Sciences and Pharmaceutical

Lilly's Alzheimer's drug trials show mixed results

August 24, 2012

Eli Lilly and Co.’s experimental Alzheimer’s drug failed to meet its primary goals in two separate clinical trials. However, when the results of both trials were combined, the drug appeared to have slowed the decline of cognition in some patients.

The Indianapolis-based drugmaker announced the mixed clinical trial results Friday morning. The drug, called solanezumab, was studied in a total of more than 2,000 patients with mild or moderate Alzheimer’s disease.

The drugmaker's stock rose 7.5 percent  in premarket trading.

Lilly’s analysis of the data after the trial showed that solanezumab slowed cognitive decline in mild Alzheimer’s patients but not in moderate ones.

The finding, in a subgroup of patients, wasn’t expected by analysts and investors, who had given the drug a less than 20 percent chance of showing any benefit.

That finding is a first for any drug trying to combat the memory-sapping malady, which afflicts 5 million Americans and 18 million people worldwide. Lilly is trying to make solanezumab the first drug to successfully fight the progress of Alzheiemr’s disease, which, if successful, is almost certain to generate billions of dollars per year in sales.

A similar-acting medicine from Pfizer Inc. and Johnson & Johnson failed to show a benefit earlier this month. If approved for a wide population of Alzheimer’s sufferers, the treatment may “transform” Lilly and bring in $5 billion to $10 billion in annual sales, said Goldman Sachs analyst Jami Rubin in a note to clients last month. That would be much needed revenue for Lilly as it braces to lose $7 billion from generic competition over the next five years.

"We recognize that the solanezumab studies did not meet their primary endpoints, but we are encouraged by the pooled data that appear to show a slowing of cognitive decline," said Lilly CEO John Lechleiter in a prepared statement. "We intend to discuss these data with regulatory authorities to gain their insights on potential next steps."

That could include another clinical trial of solanezumab aimed at patients with who have yet to develop full-blown Alzheimer’s symptoms. That’s because recent research has shown that that suspected causes of Alzheimer’s disease begin 10 or even 20 years before a patient can be diagnosed with the disease.

Lilly’s drug solanezumab fights Alzheimer’s by trying to remove a protein called amyloid beta from patients’ brains. The build-up amyloid into clumps and plaques is believed by many to stop the functioning of neurons, leading to memory loss and eventually death.

The only other therapy in late-stage testing is Baxter International Inc.’s Gammagard. The product is an expensive, relatively scarce treatment derived from donated blood plasma that replaces antibodies in people whose immune systems can’t protect them from infection. Results from a final-stage study on whether it could slow or stop Alzheimer’s may be available next year.

Lilly lost patent protection last year on its top-seller Zyprexa for schizophrenia and will lose the patent next year for its second-best seller, the anti-depressant Cymbalta. The drugs combined for 36 percent of Lilly’s 2011 revenue.

Lechleiter has said the company’s annual revenue will not be less than $20 billion and profit will remain more than $3 billion through 2014. In 2011, Lilly brought in revenue of $24.3 billion with a profit of $4.35 billion.

Lilly has 11 other medicines in late-stage testing, six of which may generate more than $1 billion each in peak annual sales, said Jeffrey Holford, an analyst with Jefferies Group Inc. in New York. Sales from those drugs won’t come soon enough to overcome the losses Lilly faces through at least 2017, he said.
 

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