Monday’s approval substantially lowers the the bar for new drugs targeting Alzheimer’s, according to Barbier. Biogen’s drug had mixed results in clinical trials and faced skepticism from some scientists. For it to remain on the market, Biogen needs to do more research.
“FDA is asking Biogen to eventually show evidence of efficacy in a real-world setting,” Barbier said.
Cassava, for its part, still remains years away from regulatory approval. The company would need to run large placebo controlled studies—the gold standard of clinical trials—which Barbier said it plans to start in the latter half of the year.
Even so, the many setbacks Biogen’s aducanumab has faced highlight the complicated road to regulatory acceptance. But for small investors looking to capitalize on that hope, Cassava at roughly $70 a share and a handful of other small biotechs look like attractive gambles.
Drugmaking juggernauts like Eli Lilly & Co. and Roche Holding AG have also been testing treatments similar to Biogen’s, but Cassava’s drug targets a different protein and it’s likely the only biotech pursuing this pathway.
Before Monday’s approval Barbier expressed hope for Biogen’s drug, “just because there’s nothing out there for patients. But, it’s not the be all end all.” In another decade there may be several new drugs on the market, he said. “It’s not a winner takes all situation,” according to Barbier.
Pain Therapeutics
Long-time biotech investors may remember Cassava by a different name, Pain Therapeutics Inc. In 2000, the company was a Bill Gates-backed initial public offering that was banking on the promise of a new generation of painkillers. The company threw in the towel on its painkiller dreams in 2019, changed its name to Cassava, and refocused on Alzheimer’s and other neurodegenerative diseases.
Despite a stock rally that makes his 5% stake—including options—worth more than $100 million, Barbier says he’s not selling. “I know the science, I know the data, I know the disease and this stuff looks promising and I’m putting my money where my mouth is.”
This article was provided by Bloomberg News.