Friday, December 30, 2016

Can Biogen win where Eli Lilly failed?

At the beginning of December, I did some venting about the miserable record of the biopharmaceutical industry’s inability to slow, let alone cure, Alzheimer’s. But on December 10, the lead article in the Boston Globe’s business section was headlined “Hopes rise for approach to combat Alzheimer’s.” Was this just another tease? The article, written by Robert Weisman, suggested that the failure of Eli Lilly opened the door to Cambridge-based Biogen. As with Eli Lilly’s failed drug candidate—solanezumab—Biogen’s compound has a long name: aducanumab. On December 21, Weisman wrote about Michel Vounatsos, Biogen’s incoming chief executive. The banner headline stated, “Alzheimer’s is top challenge, Biogen CEO says.”
According to Weisman, recent research by Biogen confirmed data indicating that aducanumab decreased levels of plaque among individuals who continued to take the drug after the clinical trial was over. This was encouraging—both to the people who took part in the clinical trial and, of course, to Biogen and its investors. Yet Weisman noted that optimism was “tempered” about the drug candidate because a biotechnology analyst estimated that there was only about a 35 percent chance that the drug would ever be approved. In the world of Alzheimer’s research, however, anything better than a one-in-three chance sounds highly encouraging. Keep in mind, of course, that the only Alzheimer’s drugs on the market today are Aricept and a few other drugs, none of which claim the ability to hinder the disease’s progress, let alone stop it. So any genuine progress to slow the disease would be a big deal.
But, as always with Alzheimer’s research, big challenges lie ahead. One drawback: One of the people in the clinical trial suffered a seizure. Weisman’s article did not make clear whether the seizure was directly caused by aducanumab, and Samantha Budd Haeberlein, Biogen’s vice president of clinical of discovery and development, took an optimistic view, suggesting that the data from clinical trials “shows that we can take patients more slowly to their designated doses and still see efficacy.”
Nothing will happen overnight, of course. According to Weisman, Biogen’s forthcoming clinical trial will be mammoth—as many as 3,000 participants spread among twenty nations. Will I be volunteering? I hesitate because I seem to be able to bear Aricept at only very low doses, and I suspect that would be the case with the drug in the Biogen clinical trial as well. I cherish my sleep—as anyone with Alzheimer’s should—and I’m wary of being knocked off my daily regimen by poor sleep hygiene.

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