Roche drug trial backs Lilly on Alzheimer’s findings

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Two years ago, Eli Lilly and Co. created excitement and skepticism when it announced clinical trial results from its highly anticipated Alzheimer’s treatment, solanezumab.

Now Indianapolis-based Lilly has company. This month, Switzerland-based Roche presented results of its Alzheimer’s drug, and the result was remarkably alike.

The two Phase 3 trials of Lilly's drug failed to show meaningful effect in the patients studied. Yet, Lilly insisted, when it looked only at patients with mild Alzheimer’s, there were significant improvements.

That interpretation fueled a burst in Lilly’s stock price at the time, because any successful drug for Alzheimer’s would be a multi-billion-dollar commercial bonanza. Even today, however, some investors and analysts say Lilly was merely spinning another late-stage pipeline failure.

But Roche's results suggest Lilly wasn't just playing games with its data.

Overall, the test of Roche's crenezumab failed. But there were signs of effect in mild Alzheimer’s patients. Also, just like Lilly’s drug, Roche’s Alzheimer’s medicine appeared to improve patients' mental abilities, but not their ability to do the functions of daily living, like dressing themselves.

Roche presented the data on crenezumab July 16 at the Alzheimer’s Association International Conference in Denmark.

“The recent report by crenezumab at the Alzheimer’s meeting in Copenhagen, I think, supports the data that we have with solanezumab,” Jan Lundberg, Lilly’s head of research and development, told investors last week on a conference call.

Some analysts took the same lesson from Roche’s study, saying it validated Lilly’s results from its clinical trails of solanezumab, called Expedition I and II.

“This essentially mirrors what was seen with Eli Lilly's solanezumab from the Expedition I and II trials [i.e. a cognitive benefit in mild patients only] and it lines up with what the current scientific consensus thinking is on the subject, which is that for these types of drugs to have a benefit they probably need to be given early in the course of disease,” Dr. Tim Anderson, a pharmaceutical analyst at Sanford C. Bernstein, said in a July 16 note to investors.

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

Lilly does not expect to have results from its latest study of solanezumab—which is aimed only at patients with mild Alzheimer’s disease—until 2016.

Anderson noted that in 2016, there will be 2.6 million patients with mild or moderate Alzheiemr’s disease in the United States and Europe, rising to 4.3 million by 2024. And there will be even more patients with earlier signs of Alzheimer’s, who are known as pro-dromal patients.

He predicts a successful Alzheimer’s treatment could be sold for an annual price ranging from $5,000 to $20,000. (By comparison, Lilly’s recently approved cancer drug Cyramza will sell for more than $6,000 per dose, or $24,000 for a single course of chemotherapy treatment. And the hepatitis C drug Sovaldi sells for $84,000 for a 12-week course of treatment.)

So if a successful Alzheimer’s drug captured half the patients in the U.S. and Europe—where there will be no competiting medicines—and sold for the mid-point price of $12,500 per year—it would generate annual sales by 2024 of $24 billion.

Referring to Alzheimer’s disease as AD, Anderson wrote, “a drug that successfully modifies AD progression could make [the cholesterol drug] Lipitor (sales peaked at  about $12 billion) look like a mid-sized product.”


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