Biogen‘s (NASDAQ:BIIB) history so far with Alzheimer’s disease drug Aduhelm is like a biotech soap opera. In this Motley Fool Live video, recorded on July 19, 2021, healthcare and cannabis bureau chief Corinne Cardina and Motley Fool contributor Keith Speights discuss whether the company will be able to move past all of the drama surrounding its controversial drug.
Corinne Cardina: Let’s dig into the Biogen issue a little bit more. We’ve talked about the FDA issue. Basically, FDA approved Biogen’s somewhat controversial Alzheimer’s drug.
I’m sure you and Brian have talked about that in depth. But here is the latest. Some private insurers has said they’re not going to cover it. Medicare is doing some review to look into when the government would be willing to pay for it. They set the price around $50,000 annually.
And then acting FDA Commissioner Janet Woodcock actually publicly acknowledged that the agency could have handled it better. She was asked a question and she didn’t totally defend exactly what happened where the FDA went against the Advisory Committee’s thumbs down. Some of the Advisory Committee members actually resigned, upset about this.
What is the latest, Keith, with what investors should know about Biogen? Obviously, the stock went up after the drug was approved. But now it’s starting to get a little bit hazy in terms of, is anyone actually going to be prescribed this drug and have it covered by some payer?
Keith Speights: Yeah. Corinne, I think you were very diplomatic when you said that this approval was “somewhat” controversial. [laughs] This approval, it kicked the hornet’s nest. This has been as close to a soap opera as you’re going to find in the biotech world.
Let’s go back to 2019 very quickly. Biogen had practically thrown in the towel on this drug after it flopped in late-stage clinical testing. It was considered just dead, basically.
Then it’s nearly like the phoenix from Greek mythology. The drug, which was then called aducanumab, it rose from the ashes. Biogen, several months after seemingly throwing in the towel, parsed through its clinical data and found a potential path to approval. And investors cheered, but a lot of folks were skeptical. They were thinking, “Yeah, right. This thing is not going to get approved.”
You mentioned some of the fireworks that have exploded since the Advisory Committee voted overwhelmingly against approval. The FDA approved the drug anyway. Several of the members of that advisory committee resigned in protest. You mentioned the investigation that has been called as to whether or not the FDA staff had improper contacts with Biogen during the review process.
This is just a big mess, basically. As you mentioned, there also are reports that healthcare providers are stating they won’t prescribe Aduhelm. At least half a dozen — so far — Blue Cross Blue Shield plans are saying they won’t cover this drug, and it could get worse from there. A lot of drama. Like I said, a biotech soap opera.
Even with all of this, I fully expect that Aduhelm is going to generate billions of dollars in sales for Biogen. I think this is highly controversial. There are a lot of folks taking sides. A lot of doctors won’t recommend or won’t prescribe the drug. A lot of payers may not cover it, but Medicare will and there’ll be plenty of doctors who will prescribe it because there really aren’t any other approved treatments that they can go to for Alzheimer’s disease. Even though they might be skeptical as to whether or not Aduhelm works, I think you’re going to see a lot of doctors prescribe it because the patients are going to want it.
So I think Biogen is going to make a lot of money off this thing despite the controversy. It is important to note, though, that Biogen has some challenges on its hands. It’s sales of its bread-and-butter, multiple sclerosis franchise are declining, sales of its final muscular atrophy drug Spinraza are falling, and so Biogen really needs this. And I think again, this is a mess, but Biogen is going to make a ton of money.
Cardina: Yeah, absolutely. In the regulatory process, the patients and the patients’ families and the advocates in the Alzheimer’s and dementia community, they don’t have that many options. This is not a cure drug. It purportedly delays the progression of the disease, and so there’s going to be a ton of patients and families out there who want to try it. They’re trying everything, and so I think you’re totally right about that.
We’ll have to keep an eye on it. It’s going to be very interesting to see if Biogen is successful in commercializing this. They definitely don’t have an easy path ahead of them, so we will definitely keep an eye on it.
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