Biogen, awaiting FDA nod for $2B Swiss plant, plans to ship initial Aduhelm doses from North Carolina factory

Biogen has been beefing up manufacturing on both sides of the Atlantic ahead of a green light for its Alzheimer's disease drug aducanumab. Flush with an approval—and a label that could tee up millions of patients for treatment—it's ready to hit the ground running, the company's head of global manufacturing and technical operations said.

To gear up for the launch, the company has spent the past several years kitting out its facility in North Carolina's Research Triangle Park and building a bioprocessing plant in Solothurn, Switzerland, hiring more than 500 new employees along the way, manufacturing exec Nicole Murphy told Fierce Pharma. Biopharmaceutical manufacturing, which is complex, pricey and time-consuming, "takes a bit of an army," she explained. 

Biogen will initially call on its facility at Research Triangle Park to supply the drug in the U.S., though it hopes to quickly bring its Swiss plant into the mix. There, the company figures it’s built enough capacity to supply the drug to more than 1 million patients per year, Murphy said.

That capacity should be plenty for Aduhelm’s early days, but the company is prepared to further bulk up its U.S. and European sites to eventually supply around 2 million patients a year if the demand is there, Murphy said on an investor call Tuesday. If that still isn’t enough, Biogen has laid the groundwork in Switzerland to expand capacity to supply 4 million patients a year, she added.

After Monday's FDA accelerated approval for Aduhelm to treat all Alzheimer's patients, Biogen plans to start shipping the drug in about two weeks, Murphy said on Tuesday's call. Some 900 treatment centers around the U.S. are ready to start administering the drug, CEO Michel Vounatsos added.

RELATED: Ready, set, prescribe? Doctors detail why they'll deploy Biogen's new Alzheimer's drug—or not

Biogen’s hitting the ground running with “significant inventory on hand,” according to an approval presentation that accompanied Tuesday’s call. The company spent much of 2020 building a safety net of raw materials and components to deflect any potential pandemic supply blows, Murphy added.

In the U.S., Biogen started revving up its North Carolina plant shortly after its 2019 decision to file aducanumab with the FDA.

In the long run, Biogen plans to tap its Swiss plant as the chief supplier of Aduhelm drug substance should it win FDA approval. The plant recently snared an OK from Switzerland’s drug regulator, and Biogen plans to seek FDA approval to make Aduhelm there “later this year,” Murphy said.

Looking to make a serious bioprocessing splash, the company started building its Solothurn plant back in 2015. So far, it's spent around $2 billion on the Swiss plant.

The company already makes Aduhelm there in one of two biological manufacturing cells. That's "basically what we refer to as a production unit," Murphy said, which includes two seed trains, four large-scale bioreactors and a purification train, Murphy said. 

The company expects the second cell to come online “within the next few months,” though once again, this will hinge on demand for the drug. Running at full speed, the Swiss plant would have a whopping 148,000 liters of production capacity, Murphy said on the call.

RELATED: Biogen's high price for Aduhelm—plus the drug's broad label—could trigger drug pricing reform, analysts say

With an approval on the docket, Aduhelm is in line to potentially reap some $10 billion in peak sales, analysts predict. The company plans to launch the drug with a price tag of around $56,000 per patient per year, several times higher than what market watchers had predicted.

Aduhelm had a long and troubled path across the regulatory finish line, and Monday’s approval has added fresh fuel to the fiery debate on the drug’s merits. Now the first Alzheimer’s drug approved since 2003, Aduhelm has ginned up considerable public support from patients and advocacy groups such as the Alzheimer’s Association, but it has its share of detractors, too.

In fact, an FDA advisory committee gave an overwhelming thumbs down on the drug back in November. After the approval, one of its members has resigned.