Biogen’s C-suite remains bullish that its controversial Alzheimer’s disease drug aducanumab will be approved in the coming weeks, citing a rare glimmer of hope from a similar drug from Eli Lilly that posted broadly positive data today.
Biogen’s CEO Michel Vounatsos kicked off by saying: ”We stand behind the [aducanumab] clinical data, and we continue to believe that the results support approval.”
He added that Biogen is “continuing to engage with the FDA” as it finishes off its review, and “continue to have very good regulatory interaction, all around the world [for aducanumab].”
He said Biogen is “ready to launch in the U.S. and we are looking forward to the FDA decision,” which is expected by early March.
He added that its Alzheimer’s programs, which includes BAN2401, was also boosted by Eli Lilly’s positive phase 2 data for its amyloid drug, posted this morning.
“We see the science is reinforced today with the news from another very important company [Lilly]. He later added his congratulations to Lilly, saying this adds “momentum and belief” for the amyloid hypothesis, which he acknowledged has been discredited “until today”.
Beta-amyloid plaques are believed to form in the brain and spur the memory-wasting disease. It has been an intense topic of research and debate, but has yielded weak results at best, and is predominately littered with years of failure.
In response to investor questions, which focused heavily on aducanumab, Al Sandrock, head of Biogen’s R&D, said he did see a positive read-through from Lilly’s data for donanemab, which in a topline peek showed a “significant slowing of decline in a composite measure of cognition and daily function in patients with early symptomatic Alzheimer's disease compared to placebo.” Lots of questions however still remain about its efficacy and safety.
“I think it’s very, very exciting for patients and an additional reason to hope for a disease modifying-therapy for this terrible disease,” said Sandrock. “Also great for our field in general. The Lilly antibody has a lot of similarities to aducanumab—seems to target a form of amyloid in the plaque.”
He added that there were also a lot of similarities in the antibodies, imaging outcome measures and trial design.
Responding to investor questions over the negative AdComm for the drug, which advised the FDA not to approve late last year, and the “divergence of thought” at the regulator, Vounatsos said his first reaction was that he was “very surprised” by the AdComm’s rejection.
“My only comment is that we were prepared to answer every single question asked by the panel, if only we were given a chance to answer.” Sandrock added that he was “equally surprised […] the advisory committee vote is non-binding, and there is plenty of precedence for FDA to not go along with the vote of the committee. Listen, we remain in review, and we’ll find out hopefully by March 7 what their decision is.”
Biogen’s shares shot up around 4% after the J.P. Morgan healthcare conference panel this morning.