Biogen And Eisai Rewrite Alzheimer’s Drug Marketing Pact
Eisai is giving up its share in profit from the drug Aduhelm, and instead will get royalties from Biogen
Alzheimer’s drug Aduhelm was approved last year in the U.S.PHOTO: POOL NEW/VIA REUTERS
By Joseph Walker Follow
March 14, 2022 7:00 pm ET
Japan’s Eisai Co. is giving up its right to share in profits from Aduhelm, the new Alzheimer’s disease drug it helped develop with Biogen Inc., in the latest sign of the drug’s diminished financial prospects.
Biogen and Eisai said on Monday that they amended their collaboration agreement to give Biogen full authority to make regulatory and sales decisions regarding Aduhelm, which was approved last year in the U.S. in a controversial decision by the Food and Drug Administration.
Under the new terms, Eisai starting next year will surrender its right to share in profit and losses related to Aduhelm.
Beginning in 2023, Eisai will receive royalties starting at 2% of Aduhelm’s global sales, increasing as sales rise, reaching 8% when Aduhelm’s sales exceed $1 billion annually, the companies said.
The sales outlook for Aduhelm has diminished significantly since the drug was first approved last June. Health-insurers have balked at paying for it and many doctors have declined to prescribe it.
Medicare, the federal health insurance program for people over 65, has proposed to pay for Aduhelm only in narrow circumstances where patients are enrolled in randomized clinical trials. In December, health regulators in Japan and the European Union declined to approve Aduhelm.
Analysts project 2022 Aduhelm sales of $33.8 million, according to FactSet.
The companies said the financial terms of their partnership to develop a different Alzheimer’s drug, lecanemab, would remain unchanged. Eisai is responsible for leading the regulatory approval process for lecanemab globally, and Biogen is entitled to 50% of profits and losses related to the drug.
Eisai began submitting data to the FDA last year to support an early approval for lecanemab. The companies extended their agreement for Biogen to manufacture the drug from five years to 10 years.
“We believe this new arrangement will be more effective and enable more focused execution with the goal of maximizing the value of both Aduhelm and lecanemab,” said Eisai Chief Executive Haruo Naito.
The revised agreement will give Biogen greater flexibility to react to market dynamics related to Aduhelm, including the pending Medicare coverage decision, Biogen Chief Financial Officer Michael McDonnell said in an interview. The revised deal terms won’t affect Biogen’s financial outlook for 2022, he said.
“It gives Biogen increased operational efficiency and the ability to be a bit more agile to address market conditions,” Mr. McDonnell said. “It gives Eisai the ability to increase its focus on lecanemab, and increase its efforts there.”
Under the companies’ old Aduhelm agreement, Biogen led the regulatory approval process except for in Japan.
Exc. |
