Myriad Genetics and Alzheimer's: How to Lose $100 Million in 40 Days
The failure of Myriad Genetics' experimental Alzheimer's drug Flurizan is surely unfortunate news for those with the disease and their families, but it also reflects badly on the Danish pharma H. Lundbeck, which paid Myriad $100 million on May 22 for European rights to the drug. Since Myriad has discontinued work on Flurizan, that's $100 million that Lundbeck and its shareholders won't see again.
On the surface, this deal looked like a classic pharmaceutical bet. By obtaining the rights ahead of pivotal "phase III" trial data for Flurizan, Lundbeck essentially wagered $100 million that the drug would work against the certainty that it would have to pay much more for Flurizan if the trial had turned out well -- assuming it could have afforded rights at all for what would have been a certain blockbuster.
But the risk of ponying up for Flurizan was a lot higher than for most compounds. The drug itself is a modified form of a common class of pain relievers known as non-steroidal anti-inflammatory drugs, none of which have shown any particular effectiveness against Alzheimer's.
Flurizan also failed to meet its endpoints in a mid-stage "phase II" trial, and survived only because Myriad and its researchers successfully tortured an effectiveness signal from a post-hoc analysis of a patient subgroup -- in this case, people with an early stage of the disease. This sort of after-the-fact data-mining almost never holds up later -- FDA's cancer-drug czar Richard Pazdur likens it to firing an arrow into the wall, drawing a target around it and declaring a bullseye.
So Lundbeck ended up paying $2.5 million a day for its short-lived flirtation with Flurizan. Maybe it didn't have much choice -- as Derek Lowe notes, the company has a big patent-expiration problem in 2012, when its antidepressant Lexapro loses exclusivity -- but that just makes it all the more pathetic. As one of Lowe's commenters put it: "The most frequently reported side-effect of Flurizan is suicidal ideation in investors."
On a scientific level, it's also worth noting that Flurizan's cratering also puts a dent in the leading disease-mechanism theory of Alzheimer's. Much of the scientific community -- and a whole host of drug developers -- are committed to the idea that the protein beta amyloid causes the disease by clumping around brain neurons and killing them. The theory hasn't ever been proven -- among other things, some Alzheimer's patients have no amyloid plaques in their brains -- but that hasn't stopped any number of pharmas and biotechs from pouring millions into anti-amyloid drugs.
Of course, the amyloid theory isn't dead, either, and several other amyloid-drug candidates are in late-stage trials right now -- including Elan and Wyeth's bapineuzumab and Lilly's gamma-secretase inhibitors. At this point, odds are good that Lundbeck won't lack for company in the Alzheimer's doghouse before long.
MRI scan of an Alzheimer's brain via Wikimedia Commons
