Biogen Executives Accuse Critics and Media of Encouraging ‘Misinformation’ As Aduhelm Launch Lags Expectations

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If Biogen thought that selling its first Alzheimer’s treatment, Aduhelm, would be an easy feat, there was another thought ahead.

Senior Biogens officials admitted on Thursday that its task of deploying Aduhelm, which some analysts have called the largest in biopharma history, has fallen short of its own expectations.

Unfortunately, Aduhelm is getting off to a slow start as Biogen’s multiple sclerosis drug Tecfidera loses sales to high-speed generics, helping to push overall sales down to $ 2.7 billion from $ 3 billion. $ 7 billion a year ago.

But there are many reasons why the FDA approval did not immediately open the floodgates for Aduhlem’s prescriptions. On the one hand, hospitals and insurers are on hold as the Centers for Medicare and Medicaid Services (CMS) execute their nationwide coverage decision, which will ultimately decide which Alzheimer’s patients to undergo programs. Federal insurance will be covered, if applicable. Some clinical sites have categorically refused to dose patients with treatment in the meantime.

Then there are the less than favorable headlines from Aduhelm. In a conference call with analysts, CEO Michel Vounatsos lambasted critics and the media for generating controversy and background noise about the highly controversial treatment since getting a historic nod from the FDA in June.

RELATED: Facing Historic Launch, Biogen To Ship Alzheimer’s Drug In 2 Weeks As Nearly 1,000 Treatment Sites Set To Go

Vounatsos said Oppenheimers Jay Olson was absolutely correct in classifying Biogens’ media attention as an assault during analyst Q&A during the company’s second quarter earnings call.

The comments came after a strong defense from Biogen’s chief research and development officer Alfred Sandrock, MD, Ph.D. In a statement, Sandrock said Biogen welcomed a “formal review” of the seemingly comfortable relationship. of the company with the agency before Aduhelm’s approval.

The Alzheimer’s drug has been the subject of “vast misinformation and misunderstanding,” Sandrock argued, pointing to the more than 250 other drugs that have gained fast track approvals since 1992.

Some experts doubted the theory that removing amyloid plaque would actually benefit patients, but Sandrock said earlier anti-amyloid antibodies did not effectively remove the protein from the brain. He also said the company had not separated its data from late-stage testing through a “post hoc” analysis, as some have suggested.

Despite its headwinds, Biogen is still seeing tremendous progress, Vounatsos added.

Of the 900 sites Biogen had previously determined were ready and willing to administer Aduhelm, approximately 325 have either given favorable opinions on the treatment or do not require any review at all.

For those who have denied access, US President of Biogens Alisha Alaimo has suggested that doctors can still prescribe the infusion treatment elsewhere.

The company said CMS’s decision to create a nationwide reimbursement policy should bring clarity to healthcare providers in the coming months.

Our teams go out of their way to put themselves in front of decision-makers to help them better understand science and data, said Alaimo.

Currently, local Medicare contractors are responsible for coverage decisions. Based on recent precedents set for CAR-T treatments, Biogen predicts that patients on contractors and Medicare benefit plans will be covered, Alaimo said.

RELATED: A $ 57 Billion Drug? Medicare faces massive bill for Biogen’s Aduhelm, even though it limits coverage

Biogen is confident that it will be able to get the ball rolling in the months to come. Doctors are developing protocols, scheduling beta-amyloid plaque tests, and discussing those results with their patients, Biogen said.

These tests, largely not covered by insurance plans, could cost patients thousands of patients, but Biogen is putting up the costs of the bioassays used to screen for amyloid in patients with lumbar punctures, has a senior Biogen official told Endpoint News.

For months, the Cambridge, Massachusetts-based pharmaceutical company maintained that Aduhelm’s adoption would be gradual. Much of the $ 2 million in Aduhelm sales reported by Biogen on Thursday is inventory heading to clinical sites, but it’s still very early days, executives said.

For Jefferies analysts, Biogen’s comments Thursday suggest “good, strong early demand,” according to its own research, according to a note to customers Thursday. Although the company did not disclose the number of patients, Jefferies was encouraged by the “very high” interest in the treatment and Biogen’s efforts to expand access.

In total, Biogens revenue in the second quarter fell to $ 2.7 billion, from $ 3.7 billion reported in the same period last year.

Much of the drugmakers’ loss was blamed on an 80% year-over-year decline in U.S. sales for its multiple sclerosis drug, Tecfidera, which faced a ambush of competition from imitators. The treatment garnered $ 178.4 million in U.S. sales in the quarter, up from $ 913 million last year.

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