Home health remedies Biogen gears up Swiss manufacturing facility for potential aducanumab rollout

Biogen gears up Swiss manufacturing facility for potential aducanumab rollout

20
0
SHARE

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. 

Webinar

Maintaining Momentum: Applying Recent Regulatory Guidance in the Midst of the Coronavirus

A panel of CATO SMS experts will review the key issues contained in the emerging Agency Guidance and offer thoughts on what changes and options for sponsors may be seen in the coming months.

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. 

RELATED: Biogen execs outline setbacks, and potential gains, from COVID-19 pandemic

Source link