Biogen gears up Swiss manufacturing facility for potential aducanumab rollout
Biogen has delayed its regulatory filing for aducanumab until the third quarter. (Biogen)
Biogen has had a rocky road with its controversial Alzheimer's disease candidate aducanumab, which it brought back from the dead late last year. But despite postponing the drug's FDA filing by half a year, Biogen is still moving forward with plans to scale up production if aducanumab eventually passes muster.
Biogen has wrapped up construction on a "state-of-the-art" facility in Solothurn, Switzerland, that will be ready to manufacture aducanumab at scale beginning in mid-2021, CEO Michael Vounatsos told analysts on the company's first-quarter earnings call.
The Swiss facility is expected to be operational by late 2021 and will tag-team commercial aducanumab production alongside Biogen's North Carolina manufacturing facility, Vounatsos said.
Of course, those production plans are predicated on Biogen securing an approval for aducanumab, a controversial Alzheimer's candidate co-developed with Eisai that has faced major trial disappointments and now, delays to its regulatory filings.