Biogen’s Expected Filing for Alzheimer’s Drug Aducanumab Delayed Until Q3

Before the COVID-19 pandemic, this period would have been a time when all eyes were on Biogen to see if they had filed with the U.S. Food and Drug Administration (FDA) for its Alzheimer’s drug aducanumab. Slightly over a year ago, in March 2019, Biogen and Tokyo-based Eisai, announced they were discontinuing the global Phase III clinical trials, ENGAGE and EMERGE, of aducanumab in patients with mild cognitive impairment for Alzheimer’s and mild Alzheimer’s dementia. They were also discontinuing the EVOLVE Phase II trial and the long-term extension PRIME Phase Ib trial. An independent data monitoring committee indicated they were unlikely to hit their primary endpoint.

It appeared to be the final nail in the amyloid theory of Alzheimer’s disease. Aducanumab is an antibody targeting beta-amyloid, one of the proteins that accumulates in the brains of Alzheimer’s patients.

But in October 2019, the two companies announced plans to pursue regulatory approval for the drug. The Phase III EMERGE trial met its primary endpoint, showing a significant decrease in clinical decline. Biogen presented the findings in the final data analysis in a December conference, and although there was still some skepticism about the overall data, it did appear to be enough to file for a Biological License Application (BLA) and the company planned to do so in the second quarter of 2020.

Today, Biogen presented its first-quarter earnings for 2020, and one of the announcements was that although the company had begun to submit parts of the BLA, they did not expect to complete it until the third quarter of this year. Company shares dropped 6% at the announcement.

Biogen also had very bad press in March, at the beginning of the pandemic, when a Biogen employee with the disease spread it at an off-site corporate meeting at a Boston hotel. A minimum of 100 COVID-19 cases have been associated with the super-spreader event.

Aside from those two major issues, the company reported first quarter total revenues of $3.534 billion, up 1% from the first quarter last year. Multiple sclerosis (MS) revenue increased 9% from the previous year to $2.280 billion. Spinraza, its drug for spinal muscular atrophy (SMA), grew 9% to $565 million, and biosimilars revenue climbed 25% to $219 million.

The company estimated that product revenues actually grew about $100 million because of accelerated sales caused by the pandemic, mostly in Europe. However, other revenues dropped 63% from the previous year, mostly due to about $200 million of hemophilia inventory that went to its spinoff, Bioverativ in the first quarter of 2019. Bioverativ was acquired by Sanofi in January 2018.

“We delivered strong financial results in the first quarter, and we continued to develop and expand our pipeline, including making good progress toward the U.S. regulatory filing for aducanumab, as well as bolstering our efforts in gene therapy through a collaboration with Sangamo,” stated Michel Vounatsos, Biogen’s chief executive officer. “The magnitude and uncertainty surrounding this pandemic clearly introduce unanticipated s potentially unquantifiable risks to our business and results over the near-term. That said, we believe that compelling opportunities exist in the therapeutic areas we are pursuing. This crisis has had a profound impact on our organization and the world at large. We have taken a broad set of actions, and we will remain fully engaged.”