With an FDA nod in hand for Alzheimer's disease drug Aduhelm, Biogen faces what analysts have chalked up to be one of the biggest drug launches in biopharma history. With those high expectations set, Biogen's top brass say they're ready to infiltrate the untapped market—starting with deliveries to nearly 1,000 infusion centers across the U.S.
In two weeks, the Massachusetts-based company will begin shipping the first doses of its amyloid-targeting antibody Aduhelm, CEO Michel Vounatsos told investors on a call Tuesday. More than 900 sites stand ready and willing to administer the treatment, including clinical trial centers with patients who have already been tested for amyloids plus other sites with the needed equipment to diagnose and treat patients, Vounatsos said.
That’s roughly 300 more centers than the company expected to have on board in late April, but there still could be room to grow. The drugmaker has profiled roughly 1,200 sites that have the infrastructure to administer doses, which account for “the large majority of already clinically diagnosed patients,” Biogen's U.S. president Alisha Alaimo said on the call.
“We are covering a large proportion of those patients, and, as we launch and as we learn, we will be readying sites in parallel to the other sites coming online,” Alaimo said.
The treatment, also known as aducanumab, is the first and only FDA-approved drug intended to change the course of the disease, not just treat its symptoms. Aduhelm is designed to break down amyloid plaque buildup that is thought to worsen Alzheimer’s and is administered through a monthly infusion.
In a surprise to many, the FDA approved the drug for all Alzheimer's patients—totaling more than 6 million people in the U.S.—even though the drug was only studied in patients with early disease. Biogen said it will launch Aduhelm “with a goal of maximizing access for early-stage patients.”
Biogen estimates that 1 million to 2 million Americans who have been diagnosed with mild dementia or cognitive impairment would be amyloid-beta positive if tested, Chief Financial Officer Michael McDonnell said.
Not all of those patients will be prescribed Aduhelm due to a variety of reasons, McDonnell said, including a lack of specialists. The majority of patients haven’t been checked for amyloids, which is done through cerebrospinal fluid or PET tests.
Considering those factors, Biogen executives predict the drug's uptake will be gradual.
“We expect revenue to start ramping in 2022 and beyond as we believe that detection and diagnosis of early Alzheimer’s disease will increase,” McDonnell said. The company has warned that 2021 sales will be modest since patients will need to be gradually titrated up to Aduhelm’s highest dose.
Thanks to its large factory in Switzerland, Biogen will eventually be able to supply more than 1 million patients with Aduhelm per year. The company hasn't won FDA approval for that site and is leaning on a factory in North Carolina for the initial launch supplies.
Beyond those launch details on Tuesday's investor call, analysts were notably concerned about the antibody’s hefty $56,000-per-year list price—several times higher than what experts had previously estimated.
Evercore ISI analyst Umer Raffat told executives that there appeared to be “a disconnect” between the company’s promise of access and health equity and Aduhelm’s price tag.
But Vounatsos responded that the company stands by the price thanks to the value Aduhelm is expected to bring to patients, caregivers and society. Chirfi Guindo, Biogen’s head of global product strategy and commercialization, added that the company has “voluntarily committed to not taking any price increase over the next four years” and will remain “open-minded.”