Biogen hasn't even filed its FDA application for controversial Alzheimer's drug aducanumab yet. But it's already started gearing up for a potential launch.
After a roller-coaster ride last year—when aducanumab was assumed dead, only to be resurrected by a new data analysis—Biogen wants to be ready when and if that coveted FDA approval comes through. So it's assembling "top talent" for its rollout teams, building up manufacturing and generally getting a move on.
Besides staffing up in medical affairs, both in the U.S. and elsewhere, Biogen is talking with pharmacoeconomists, potential customers and thought leaders about a key number—price, CEO Michel Vounatsos said during a Q&A session Monday at the J.P. Morgan Healthcare Conference.
But he said at the panel that "medicines are for the patients" and “one should not take advantage of the situation of being on the market."
"For me, success would be that patients could access the product," he added.
Biogen is also recruiting across biopharma for the effort, while of course putting its own top experts to work. Amid all that action, Biogen has developed its “go-to-market model” for the U.S., Vounatsos said, but he didn't offer any details on that subject.
On the manufacturing side, the company had previously decided to build a new plant in Switzerland, and it's expected to come online later this year, CFO Jeff Capello said at the Q&A session. The “state-of-the-art" facility will have “pretty much unlimited capacity,” he added.
In the meantime, Vounatsos said, the company’s North Carolina plant will be the first center ready to produce aducanumab for the U.S. and other markets.
Outside the U.S., the company is working with regulatory authorities in Europe and Japan on the medicine, the drugmaker said.
Of course, all of the preparations will only come into play if Biogen scores a groundbreaking approval in a disease that afflicts millions with no treatment options—and one that has confounded researchers across the industry. The drugmaker has not yet filed its FDA application, but is working to complete the filing “as soon as possible,” it said Monday.
Biogen and its partner Eisai have been working on the drug for years, but last spring ended two phase 3 tests early after a data monitoring committee determined the drug wasn’t on track to meet its primary endpoint of slowing cognitive and functional impairment. The trial result decimated Biogen’s share price, eroding nearly one-third of the company’s market value.
Then, in October, the company shocked the biopharma world by resurrecting the med based on a larger dataset. It now contends its new analyses justify seeking an FDA approval, given the enormous unmet need. Biogen regained billions as investors piled back in.
Asked about the regulatory process so far for aducanumab, Biogen R&D head Al Sandrock said Monday the situation is unlike any that he’s been a part of in his career. Going from “futility to a filing is unique in and of itself,” he said, and he noted that the high level of “constructive engagement” between the drugmaker and the FDA is “unusual” in his experience.