The company also issued an open letter to the Alzheimer’s disease community from Alfred Sandrock, which attempts to push back against negative media attention.
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Although Biogen’s controversial Alzheimer’s drug Aduhelm is reportedly having a slow launch, the company reported its second-quarter earnings that it had brought in $2 million in the first couple of weeks since approval.
The company also issued an open letter to the Alzheimer’s disease community from Alfred Sandrock, the company’s head of Research and Development, which attempts to push back against negative media attention. It has also launched an educational marketing campaign targeting the consumer.
Overall, the company’s second quarter was strong compared to Wall Street expectations but rougher than the same period in 2020. Revenue for the quarter was $2.78 billion compared to projections of $2.61 billion. Adjusted earnings per share (EPS) were $5.68 compared to the expected $4.54.
However, second quarter total revenue decreased 25% compared to the same period in 2020. Its multiple sclerosis franchise sales fell 24% compared to the previous year, although Spinraza sales for spinal muscular atrophy (SMA) increased 1%.
“We were pleased with our operational performance in the second quarter. Biogen has the market-leading portfolio of therapies for MS, has launched the first approved and market-leading therapy for SMA, and now has the first approved therapy to address a defining pathology of Alzheimer’s disease,” said Michel Vounatsos, Biogen’s chief executive officer.
“In addition, we recently reported positive data in depression and stroke, and we look forward to the expected Phase III data for tofersen, the first genetically-targeted potential therapy for ALS, for which we have begun offering individual compassionate use access,” he continued.
Sandrock’s letter systematically works its way through many of the criticisms of the drug, but the opening salvo is for critics, saying, “Unfortunately, Aduhelm’s approval has been the subject of extensive misinformation and misunderstanding. It is normal for scientists and clinicians to discuss data from experiments and clinical trials, to debate, and to disagree, on the interpretation of data. That is how science advances and we welcome these discussions. Recently, however, there had been a turn outside the boundaries of legitimate scientific deliberation.”
Sandrock points out that the U.S. Food and Drug Administration (FDA)’s Accelerated Approval Program was created in 1992. Since then, 253 accelerated approvals have been granted to drugs across various serious diseases, including HIV, sickle cell anemia, Duchenne muscular dystrophy (DMD), multiple sclerosis and cancer.
“The accelerated approval of Aduhelm has been granted based on data from clinical trials showing the effect of Aduhelm on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in the rate of clinical decline,” he writes.
One criticism has been that other drugs that reduce amyloid have been rejected and failed to show clinical benefit. Sandrock responded, “This is factually incorrect. First-generation anti-amyloid antibodies were not specific for aggregated forms of amyloid beta, or targeted soluble monomeric amyloid beta, or were deficient in effector function. As a result, these antibodies do not clear amyloid from the brain. As such, there is no basis for using the failure of these antibodies as a reason to question the approval of Aduhelm.”
He also goes after the criticism that the company’s data analysis was “post hoc,” which is to say, after the fact to interpret the data in a certain way, which he again says is factually incorrect. “The primary and secondary endpoints had been pre-specified in the Phase III trial protocols, before the first patient was enrolled into the trials.
“The Aduhelm label shows the results on these pre-specified endpoints, based on data that had already been collected at the sites by the time the trials were prematurely terminated on March 21, 2019. Safety data were also extensively reviewed and are well documented in the label so that physicians can make informed benefit-risk decisions and take appropriate actions as they monitor their patients under treatment.”
And over the criticism that Biogen was too cozy with the FDA, Sandrock notes that “collaboration between industry and regulatory agencies is common, appropriate and beneficial.”
Sandrock also quotes the FDA: “The clinical trials for Aduhelm were the first to show that a reduction in these plaques — a hallmark finding in the brain of patients with Alzheimer’s — is expected to lead to a reduction in the clinical decline of this devastating form of dementia….Although the Aduhelm data are complicated with respect to its clinical benefits, FDA has determined that there is substantial evidence that Aduhelm reduces amyloid beta plaques in the brain and that the reduction in these plaques is reasonably likely to predict important benefits to patients.”
He also points out that the approval has renewed investment activity in Alzheimer’s research and development. “We recognize that Aduhelm’s dataset was complex and its journey to this point did not follow a conventional path. But the road to innovation is rarely straightforward, and Aduhelm is not an exception,” Sandrock wrote.
The company’s new marketing campaign includes a website with a quiz for patients, and a detailed ad on The New York Times’ websites, a Facebook page, and partnerships. The campaign is also drawing criticism, with critics arguing it is using misleading information.
Adriane Fugh-Berman, a pharmacology professor at Georgetown University Medical Center wrote an op-ed in The Baltimore Sun, stating, “It’s particularly egregious because they are trying to convince people with either normal memories or normal age-related decline that they are ill and they need a drug.”
Fugh-Berman is referring to the “symptoms quiz,” which asks questions about whether a person feels depressed, struggles to come up with a word, repeats questions, or gets lost. And regardless of the answers, it directs the quiz taker to talk to their doctors about their concerns and whether more testing is necessary.
Jerry Avorn, professor of medicine at Harvard Medical School, a critic of the approval, noted that while some of those concerns may be dementia symptoms, “this clearly does overly medicalize very common events that most adults experience in the course of daily life: Who hasn’t lost one’s train of thought or the thread of a conversation, book or movie? Who hasn’t had trouble finding the right word for something?”
Biogen’s spokesperson Allison Parks told the Kaiser Health Network (KHN) that the website is part of a “disease awareness education program” that is targeting “cognitive health and the importance of early detection,” which does not mention Aduhelm by name.
