Investors gambling with new Biogen drug

KEY THOUGHT: Irrational investor exuberance. That’s the only way to describe the sudden uptake in Biogen after a PR announcement without a thorough analysis of the data by independent third parties. Jim Cramer, on MSNBC, even went as far as to say it could be the best selling drug in history.

As Alzheimer’s diagnoses rise and treatments in clinical trials continue to stall, the cost of the disease is going up—to the tune of $277 billion in the U.S. in 2018, a $20 billion increase from last year.

The numbers are based on the latest report on Alzheimer’s cost released by the Alzheimer’s Association. And the $277 billion doesn’t include one very costly element: the time caregivers sacrifice in order to care for their loved one.

According to the Association, Alzheimer’s costs $341,000 on average for the health needs of someone from diagnosis to death. Families pay 70 percent of this out of pocket. The cost of care is projected to increase to $1.1 trillion by 2050.

Alzheimer’s is a horrible disease and we are all desperate for a treatment but hope, when it comes to new drugs, is not enough. Via the Times “Biogen said on Tuesday that it would ask the Food and Drug Administration to approve an experimental drug, aducanumab, to treat people with mild cognitive impairment and the earliest signs of Alzheimer’s disease.

The company has not published the most recent analyses, and experts are mostly in the dark as to how well the drug works. It neither prevents nor cures Alzheimer’s; the company claims only that aducanumab may slow cognitive decline in some patients. In fact, Biogen announced in March that it was halting two large studies of aducanumab for treatment of Alzheimer’s disease because data showed the effort was likely to be futile.

The company resurrected the drug after additional analyses suggested it might have some effect at higher doses. (“Just in time for Halloween, aducanumab has risen from the dead,” one drug industry analyst said in an email.) The company changed the design of the second study midway through in order to give one group of patients a higher dose. As of March, the change had brought no clinical benefit. But as more data came in, officials say, the picture changed.


1ne: Biogen has provided only a summary of its data and analyses. When Alzheimer’s specialists see the details in December — better yet, when there is a peer-reviewed published paper — they may not be convinced the drug has meaningful benefits.

2wo:  The new analysis of patients receiving high doses is a risky one. In a so-called subgroup analysis, it is too easy to slice the data to justify a conclusion — that’s why large randomized trials with defined end points are so valuable. Ordinarily, a subgroup analysis is considered a way to generate a hypothesis, not a way to test whether it is true.

My take…

If the drug helps patients then I’m for it but I won’t believe it until a third-party review and analyzes the data. It’s rumored that Biogen is on the block and this could be a tactic to gain potential bidder attention. Investors are looking for the big, quick, hit but they are foolish to move so quickly. Hope for the best…expect the questions.