Biogen acknowledges risk on manufacturing provisions for aducanumab

Biogen says ‘significant capacity’ allocated to aducanumab could impact 2021 results if the potential Alzheimer’s disease treatment is not approved.

At the end of last month, Biogen announced that the US Food and Drug Administration (FDA) would delay its decision on aducanumab by three months, meaning that a decision is now expected on approval by 7 June of this year.

The monoclonal antibody (mAb) treatment could become the first therapy approved for Alzheimer’s disease to change the course of the illness. CEO of Biogen, Michel Vounatsos, confirmed on a fourth quarter investor call that this would represent a ‘multi-billion opportunity’ for the company, with a market for potentially ‘10 million patients’ in the US alone.

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As a result, the company has set aside manufacturing capacity for the potential commercial launch of the product.

On the same call, Michael McDonnell, CFO at Biogen, stated, “It is important to note that we have allocated a significant portion of our manufacturing capacity to aducanumab, which could impact 2021 results if aducanumab is not approved.”

When BioProcess Insider reached out to the company in regard to capacity assigned to aducanumab and the associated potential impact on 2021 results, a spokesperson for Biogen said the company is not sharing such details at this time.

Biogen’s manufacturing network

The company will manufacture the potential treatment from its location at the Research Triangle Park in North Carolina and from its recently finished Swiss site in Solothurn.

According to Biogen, the two sites currently have a combined capacity of 198,000L. When the Swiss site was first announced, the facility was scheduled to be outfitted with eight 18,000L bioreactors totaling 144,000L of capacity.

Previously, Vounatsos stated that this site would be expected to produce some of the commercial supply of aducanumab in mid-2021.

The company had planned to use its North Carolina site to produce the mAb for initial commercial demand but with the FDA’s decision pushed back any approval would now arrive in mid-2021.

Biogen previously reduced its overall global capacity with the sale of its Denmark site to Fujifilm, ahead of the completion of its Swiss location.