BIIB – Biogen, under pressure, tells investors it ‘stands by' the FDA review process for its Alzheimer's drug

Biogen executives sought to assure investors that the science behind its newly approved Alzheimer’s disease drug is firm despite ongoing questions about whether the drug works, how it was approved, and what it costs. 

“I want to be clear that Biogen stands behind the integrity of the review process,” Biogen CEO Michael Vounatsos said Thursday, according to a FactSet transcript of the company’s second-quarter earnings call.

Shares of Biogen Inc.

gained 1.3% in trading on Thursday. Earlier in the day, the company disclosed that Aduhelm has generated $2 million in revenue since the June 7 approval. 

Biogen executives said Aduhelm’s launch has been slower than expected, and much of the earnings call featured company executives emphasizing the therapy’s clinical benefits, explaining the lengths the company went to ensuring the scientific integrity of the clinical trials, and promoting its focus on giving patients with Alzheimer’s a new treatment option. 

Aduhelm is the first new Alzheimer’s disease treatment in two decades.

“Biogen is struggling with negative commentary, acknowledging launch is slower than expected,” Bernstein’s Ronny Gal told investors on Thursday. “They spent a good amount of the call arguing against misinformation [and] negative media comments.”

The story behind Aduhelm is complicated. Biogen in 2019 scrapped development of the drug, saying the therapy didn’t work, before telling investors later that year that it planned to resurrect the drug.

More recently, members of the influential FDA advisory committee who had recommended against approving Aduhelm quit in response to the approval. Biogen itself requested a narrower label for the drug (which was granted by the FDA earlier this month). The acting FDA commissioner requested a federal investigation into her own agency’s handling of the approval. And several hospital systems including the Cleveland Clinic in Ohio and Mount Sinai Health System in New York have said they will not offer the drug to their patients. 

“A better understanding of the facts is good for everyone involved to assure confidence in both the therapy and the process by which it was approved,” Dr. Alfred Sandrock, Biogen’s chief medical officer, said during the call. “We will cooperate fully with the review even as we prioritize the issues that affect patients.”

That means the company is moving forward with its commercial plans for Aduhelm. This includes working on reimbursement, designing the FDA-required confirmatory trial and a real-world observational study, and setting up care sites that can administer the drug. (Aduhelm is an infusion therapy that also requires brain magnetic resonance imaging scans in patients before being administered.)

Aduhelm is currently being reviewed by regulators in 10 countries, Biogen said. 

Biogen’s stock is up 31.9% for the year. Its shares hit a six-year high the day that Aduhelm was approved. The S&P 500

has gained 15.1% so far in 2021.