Biogen and Aduhelm: ‘Manufacturing capabilities will align with demand’

With minimalized demand for the one-time touted blockbuster Aduhelm, Biogen could be left with 198,000 L of mammalian capacity to fill.

Between its Swiss site in Solothurn and a plant in North Carolina, Biogen said last year it has a combined capacity of 198,000 L, capable of producing tens of millions of doses of Alzheimer’s drug Aduhelm (aducanumab).

However, despite the US Food and Drug Administration (FDA) approving Aduhelm in June 2021, the commercial future of the monoclonal antibody (mAb) has been hanging in the balance following the US government’s Centers for Medicare & Medicaid Services (CMS) program limiting the use of the medicine to patients last month.

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As such, questions remain regarding the future of the large manufacturing capacity previously dedicated to the one-time expected blockbuster.

Biogen is already feeling the financial strain through lack of sales and underutilized capacity, stating in its first quarter 2022 results this week that it was “negatively impacted” by a $275 million charge for Aduhelm inventory write-offs, and reporting a loss of $45 million due to “idle capacity.”

A Biogen spokesperson remained vague on future Adulheaim manufacturing plans, telling us: “We remain agile and are aligning our capabilities with the needs of the business.”

With the bleak reality that Aduhelm might flop, CEO Michael Vounatos told shareholders during the call that Biogen will “substantially eliminate our commercial infrastructure for Aduhelm [and] retain minimal resources to manage patients access programs,” but, again, was not specific about its manufacturing capacity plans.

The 198,000 L of bioreactor capacity could perhaps be used to support upcoming products as Aduhelm is not Biogen’s only potential money-maker. The firm has 10 programs in Phase III, including another Alzheimer’s disease mAb candidate lecanemab, which Vounatos said it plans to “submit for full FDA approval by the first quarter of 2023 with the opportunity for [it] to become the first anti-amyloid antibody to obtain authorization in the US.”

Cost-reduction plans

Biogen said during the call that it will take additional measures to save $500 million through the elimination and reduction of its Aduhelm infrastructure. This brings the firm’s expected savings to $1 billion as last December the company announced cost-reduction methods to save $500 million.

“We will implement additional cost reduction and productivity measures that will include a substantial elimination of our commercial infrastructure supporting Aduhelm as well as other cost reduction while we continue to form promising pipeline and commercial opportunities,” the spokesperson said.

“As part of these measures, this will include a reduction in head count to further align our cost with our revenue base.”

Furthermore, Vounatsos announced he will step down from his role as CEO at Biogen but will remain in the position until his successor is appointed.