Biogen last year said it would ask the FDA to review its potential Alzheimer’s disease treatment, aducanamab, sometime in “early” 2020. The submission is being made under a rolling review, in which sections of an application are filed as they are completed rather than all at once.
Now the Cambridge, MA-based company says the regulatory filing will be complete in the third quarter, an unexpected delay for a drug developer vying to commercialize what could become the first therapy to change the course of the disease.
Executives at Biogen (NASDAQ: BIIB) announced the change Wednesday in tandem with the firm’s first quarter earnings report.
CEO Michel Vounatsos said on a conference call that Biogen has made “good progress” toward completion of the regulatory filing since it last estimated when it would be submitted, including more meetings with the FDA and the submission of some of the data that will comprise the finalized package.
Al Sandrock, Biogen’s head of R&D, emphasized on the call that none of the analyses Biogen have conducted in the process of preparing the submission have changed its approach to advancing the drug.
“Nothing has come up with the data that has changed our interpretation,” he said. “We believe that the fundamentals are the same and that the potential for approval remains the same, as Michel says, from the very beginning.”
Biogen has another FDA meeting slated for this summer, said Vounatsos, who characterized the agency’s interest in the submission as “high” and asserted that the delay was not related to regulatory concerns.
He called the dataset “unprecedented and complex,” and said the coronavirus pandemic brought complications, too.
Some of the Biogen employees involved in the aducanamab filing process were among those at the biotech infected with COVID-19, Sandrock said. Earlier this year the company was at the center of an outbreak of the disease in Massachusetts; Vounatsos said Wednesday that all of its employees who contracted the virus have or are recovering.
“As a company we are prioritizing the quality of the submission versus the timing,” Vounatsos said. “We don’t want to rush and face challenges.”
Biogen’s stock price fell to $298.01 apiece Wednesday, down about 9 percent compared to market close Tuesday.
Evercore ISI analyst Umer Raffat, who spoke with the company’s management team following the conference call, said while “something must have come up” to occasion the delay, its executives’ “body language remains very positive.” He pointed to the complexity of the submission and related “data issues” as the most likely reason for the changed timeline.
“Ultimately, it does seem like [the aducanamab] filing requires more data processing (vs Q4 call where it seemed like it was just about ‘putting together documentation’),” he wrote in a research note.
Biogen also reported starting talks regarding aducanamab with regulators in the European Union and in Japan.
Read more here about the aducanamab saga, including the 2015 data that led the company to outline a Phase 3 study, the late-stage results that prompted it to shelve the drug in March 2019, and its stunning decision to reverse course months later.