I'm a bit baffled by Eli Lilly's (NYSE:LLY) strategy on Alzheimer's. Not the scientific side of it -- they're going strongly after the amyloid hypothesis with secretase inhibitors and antibody therapies, and if I were committed to the amyloid hypothesis, that's probably what I'd be doing too. It is, after all, the strongest idea out there for the underlying mechanism of the disease. (But is it strong enough? Whether or not amyloid is the way to go is the multibillion-dollar question that can really only be answered by spending the big money in Phase III trials against it, unfortunately).
No, what puzzles me is the company's publicity effort. As detailed here and here, the company recently made too much (it seemed to me and many others) of the results for solanezumab, their leading antibody therapy. Less hopeful eyes could look at the numbers and conclude that it did not work, but Lilly kept on insisting otherwise.
And now we have things like this:
'We are on the cusp here of writing medical history again as a company, this time in Alzheimer's disease,' Jan Lundberg, Lilly's research chief, said in an interview.
Just as the Indianapolis-based company made history in the 1920s by producing the first insulin when type 1 diabetes was a virtual death sentence, Lundberg said he is optimistic that the drugs Lilly is currently testing could significantly slow the ultimately fatal memory-robbing disease.
'It is no longer a question of if we will get a successful medicine for this devastating disease on the market, but when,' said Lundberg, 59.
The problems here are numerous. For one thing, as Lundberg (an intelligent man) well knows, insulin for diabetes is a much straighter shot than anything we know of for Alzheimer's. It was clear, when Lilly got their insulin business under way, that the most devastating symptoms of type I diabetes were caused by lack of insulin production in the body, and that providing that insulin was the obvious remedy. Even if it did nothing for the underlying cause of the disease (and it doesn't), it was a huge step forward. As for Alzheimer's, I understand that what Lundberg and Lilly are trying to get across here is the idea of a "successful medicine," rather than a "cure." Something that just slows Alzheimer's down noticeably would indeed be a successful medicine.
But "when, not if"? With what Lilly has in the clinic? After raising hopes by insisting that the Phase III results for solanezumab were positive, the company now says that ... well, no, it's not going to the FDA for approval. It will, instead, conduct a third Phase III trial. This decision came after consulting with regulators in the the U.S. and Europe, who no doubt told them to stop living in a fantasy world. So sometime next year, Lilly will start enrolling for another multiyear shot at achieving some reproducible hint of efficacy. Given the way solanezumab has performed so far, that's about the best that could be hoped for -- that it works a bit in some people sometimes, for a while, as far as can be told in a large statistical sample. Which sets up this situation, I fear.
And this is "on the cusp ... of writing medical history"? Look, I would very much like for Lilly -- for anyone -- to write some medical history against Alzheimer's. But saying it will not make it so.