- Biogen and its longtime partner Eisai have reworked their agreement on Aduhelm, the Alzheimer's disease drug that was controversially approved in the U.S. last June.
- Starting next year, Eisai will receive only royalties tied to net sales of Aduhelm, instead of sharing global profits and losses. Meanwhile, Biogen will take full control of all development and commercialization decisions related to the drug. Biogen CEO Michel Vounatsos said in a statement Monday that the revised deal should allow his company to more effectively and quickly address "market developments," including an important coverage decision from Medicare expected next month.
- So far, sales of Aduhelm have been anemic, despite it being the first Alzheimer's drug in the U.S. that's cleared to treat what many researchers believe to be the disease's root cause. Over the course of last year, Biogen recorded $3 million in Aduhelm revenue, far below the estimates of Wall Street analysts.
An estimated 6 million or so people in the U.S. have Alzheimer's, a disease hallmarked by a progressive decline in brain and physical function.
With few available treatment options, analysts had assumed that the first medicine approved to treat the disease itself, and not simply its symptoms, would quickly grow to become a billion-dollar product. But that hasn't been the case. Many doctors have been wary to prescribe Aduhelm, and insurers to cover it, because of the drug's price, the complicated and contradictory evidence it generated in clinical testing, and the unusual events that took place before it was submitted to regulators.
For Biogen and Eisai, which, together, earmarked $600 million for commercial launch activities, this resistance has dampened expectations around Aduhelm's use and sales.
"We are obviously disappointed with the delayed uptake of Aduhelm in the U.S.," Vounatsos told investors in October.
The tide could turn if Aduhelm secures a favorable policy from the Centers for Medicare and Medicaid Services — which, as the government insurance program for people aged 65 and older, is responsible for most of the patients eligible to receive the drug. However, a draft policy issued by the agency in January proved to be highly restrictive, limiting coverage to only those patients who take part in a type of rigorous clinical trial.
Biogen has since mounted a campaign to change the agency's mind before it finalizes its policy in April. Some analysts, though, remain skeptical of whether CMS will make significant adjustments.
Eisai has been Biogen's longtime partner in Alzheimer's research, collaborating on both Aduhelm and another, experimental treatment called lecanemab, which the companies recently decided to also submit for approval.
Per the newly outlined terms, Eisai will stop sharing global profits and losses on Aduhelm and instead receive just tiered royalties based on net sales of the drug. The royalty rate will start at 2%, but climb as high as 8% if annual sales surpass $1 billion. This payment structure takes effect on Jan. 1, 2023.
Biogen, though, will retain global commercialization rights and be solely responsible for all decisions regarding Aduhelm, effective immediately.
Aside from Aduhelm, Biogen and Eisai also revealed that they have revised a lecanemab supply deal, extending it from five years to 10. The agreement tasks Biogen with manufacturing enough of the drug to provide a "reliable commercial supply worldwide." The companies said they are continuing to jointly develop and commercialize lecanemab and still plan to evenly split profits and losses.