The unconventional path Biogen’s Alzheimer’s prospect aducanumab took through development has created significant doubts about whether the US Food and Drug Administration (FDA) will approve the drug. However, with Biogen confident it has data to show the antibody works, despite it failing a Phase III futility analysis, the big biotech is laying the groundwork for an anticipated launch.
Talking to investors on Biogen’s fourth quarter results conference call with investors, CEO Michel Vounatsos sketched out different aspects of the launch preparations, including efforts to ensure the availability of enough aducanumab to meet demand.
Vounatsos said, “The biomanufacturing needs to be stepped up and be ready for, eventually, a large demand.”
Aducanumab is widely expected to become a big blockbuster if it wins approval, with some analysts tipping the antibody to generate peak sales of $10bn (€9bn) or more. Given the pent-up demand for a new Alzheimer’s drug among the millions of US patients with the disease and their families, there is scope for sales to rise rapidly, provided barriers such as reimbursement do not impede uptake.
Rapid sales growth would be a boon for Biogen, which needs a new drug to reignite its performance, but it could also create logistical issues. Analysts probed Biogen’s ability to manage those challenges cost effectively on the quarterly results conference call.
Observing that Biogen will need “a huge amount of antibody” to meet demand, Robyn Karnauskas, an analyst at SunTrust Robinson Humphrey, asked if management could provide “any comfort” that the drug will not be “too harmful” to the company’s cost of goods sold and profit margin.
Jeffrey Capello, CFO at Biogen, offered a response, saying, “It's obviously something we've been looking at for a while. I don't want to get into too much specifics with regard to that at this point in time, but we're comfortable that given the nature of the substance that we'll produce, it will be a fair margin and that it will do well economically.”
More specifics may emerge as the aducanumab filing progresses. Biogen said last year that it would file for US FDA approval early in 2020. With the first part of the year passing without news of a filing, Biogen’s current position is that it will complete the submission “as soon as possible.”