Former CEO of Biogen, who developed Alzheimer’s drug “Aduhelm”

Skangos, now CEO of biopharmaceutical venture Vir Biotechnology, told Insider during a JP Morgan conference.

“Biogen’s initial pricing was a self-defeating, suicidal act,” he said.

In June 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Aduhelm, co-developed by Biogen and Japan’s Eisai. The previous November, an advisory panel of outside experts had voted against the approval, but the FDA did not accept its recommendation.

The US House of Representatives (Committee on Oversight and Reform and Committee on Energy and Commerce) has been investigating the process leading up to this approval and sales for a year and a half, and has published a report in December 2022.

The report pointed out that there were problems with the cooperation between the FDA and Biogen/Eisai (see below). It concluded that the approval process was “extremely irregular” and that Biogen “set an unreasonably high price.”

Skangos, who was Biogen’s top executive at the time and led Aduhelm’s move to late-stage clinical trials, said that if he had set a lower price in the beginning, “You and I would be here (referring to the interview site) like this.” I wouldn’t have spoken,” he said.

“If the original pricing had been $10,000, this discussion wouldn’t have happened because everyone would be happy to use Aduhelm.”

The purpose of “$56,000” is to “maximize profits”

The US House investigative report gave us a rare glimpse behind drug pricing.

The claim that drug companies price their drugs “based on patient value,” as they often touted, is a truism, according to a Biogen report by Stat. Ultimately, it all boils down to maximizing profits, according to an internal presentation (29 December 2022).

According to the document, Biogen has learned from its own market research that the profit realized varies depending on the pricing range.

that is,Under $20,000 maximizes access for patients, under $30,000 maximizes the value of medicines, and under $40,000 minimizes resistance from private insurers and doctors.that’s what it means.

But even with that market research insight, Biogen priced Aduhelm at $56,000.as aboveLeaving patient convenience and the understanding of medical professionals behind, and prioritizing the maximization of the company’s profits, the company chose the path of achieving “the greatest new drug launch in history.”That’s why.

However, on December 20, 2021, just six months after its launch, Biogen decided to cut the price of the drug in half to $28,200.

Almost ten days later, the advisory committee report mentioned in the previous section was published.

According to Bloomberg and other reports, three members of the advisory board resigned after FDA approval and launch. The drug faced fierce headwinds, with federally run Medicare limiting benefits for Aduhelm.

The controversial “greatest drug launch of all time” was thwarted, and Biogen itself turned to another Alzheimer’s drug, Rekenbi (generic name lecanemab), which received accelerated approval from the FDA on January 6. , It was a result of moving the axis at once.

A Biogen spokesperson declined to comment on what Skangos told Insider when asked to comment.

The spokesperson emphasized that Aduhelm can still be administered to patients, and said in a statement issued by Biogen when the US House of Representatives investigative report was released (December 29, 2022). was shared with reporters. “Biogen will remain consistent in its corporate conduct,” it said.

Criticism of “not scientific at all”

While Skangos noted the pricing issue, he said some of the criticisms of Biogen and Aduhelm were “far from scientific.”

Most of the criticism he took issue with the relationship between Biogen and the FDA, which the US House of Representatives investigative report described as an “extraordinary” partnership.

The aforementioned medical news “Stat” detailed the behind-the-scenes maneuvering of Biogen executives to get accelerated approval from the FDA, dubbed “Project Onyx” (June 2021). dated May 29).

The revelation of these “anomalies” has sparked a debate about the effectiveness of Aduhelm.

Biogen announced in March 2019 that a futility analysis conducted by an external data monitoring panel determined that continuing the study would not meet its primary endpoint. Cancellation of late-stage (Phase III) trial announced.

However, as a result of a subsequent subset reanalysis (targeting a subset of patients, not all patients who participated in the clinical trial), it claimed that its clinical efficacy was confirmed, and it applied for approval in the following year, 2020. , in some ways it creates an opaque impression.

Mr. Skangos explained the circumstances at that time as follows.

“I think Aduhelm works. The data from the Phase 2 trial was impressive.

At the time, many people kind of got on the bandwagon: ‘This doesn’t work, the FDA made a mistake, Biogen manipulated the data. They jumped on the shit (which an expert could tell) from people who didn’t know anything.”

However, while Skangos spoke of the effectiveness of Aduhelm, he emphasized that it’s not a “magic drug.” The same is true for Rekembi, which was just approved in January, he said.

All of these modestly slow the progression of Alzheimer’s disease, and while they won’t magically slow cognitive decline, Skangos said that “a little” can make a big difference for patients. rice field.

“It’s disappointing to think that so many patients who could have benefited from Biogen’s Aduhelm, or aducanumab as it’s generic name, didn’t, or didn’t, get it.”