There remain considerable doubts about whether the FDA will approve aducanumab. Phase 3 trials of the anti-amyloid antibody were stopped for futility in March 2019, only for Biogen to resurrect the therapy seven months later after going over the expanded dataset. The FDA is due to make a decision by June 7 this year.
However, even analysts who question whether the current data support the efficacy of aducanumab think there is a major commercial opportunity for the drug if it wins approval.
Biogen CEO, Michel Vounatsos, began to quantify just how big the opportunity could be at a recent investor event.
“The market is extremely large. Based on the entry criteria of our Phase 3 studies, it’s more than 10 million patients in the US only. Obviously, it doesn’t mean that all the patients qualify. It doesn’t mean that all the patients are known from the healthcare system. Some of them are not known. So the epidemiology is absolutely tremendous. It’s a multi-billion-dollar opportunity,” Vounatsos said.
Exactly how big the commercial opportunity is will depend in part on the price Biogen sets. External estimates of the likely price have hovered around the US$50,000 mark. Biogen now has a price in place, Vounatsos said, but is yet to disclose it publicly.
Vounatsos has discussed the assessment Biogen performed to calculate the value of aducanumab. The assessment of the burden Alzheimer’s place on society, which puts direct and indirect costs in the US at more than US$850bm, suggests Biogen could consider a fairly high price for aducanumab.
“We know that 75% of the patients affected at the age of 80 have to be institutionalized. And it costs more than US$100,000 a year to keep those patients in institutions, in addition to the emotional impact it has on the caregivers, on the family. So it’s a societal issue and these are key considerations in order to assess the value,” Vounatsos said.
Biogen is investing in anticipation of the drug coming to market, setting up a cross-functional team to prepare sites to treat patients and gearing up to ship products from sites in North Carolina and, later, Switzerland.
Elements of a successful launch will be beyond Biogen’s direct control. Notably, the need to check if a patient has brain amyloid will require PET scans or other tests, such as spinal fluid diagnostics or the blood-based prospects now in development.
