Eisai Gives Full Aduhelm Responsibility To Biogen Under Amended Agreement
Japanese Pharma Trades 50-50 Deal For Single-Digit Royalty
Executive Summary
The companies amended the terms of their Alzheimer’s collaboration to give Biogen full decision-making control over Aduhelm immediately. Eisai’s 50% share of profits and losses from the drug switches to a 2% royalty in 2023. The partners’ agreement for Eisai-led lecanemab remains intact.
It appears that Eisai Co., Ltd. is throwing in the towel on the troubled anti-amyloid antibody Aduhelm (aducanumab), giving Biogen, Inc. full control of decision-making for the Alzheimer’s disease therapy, effective immediately. The companies will continue to share Aduhelm profits and losses globally in 2022 – with Eisai’s development, commercialization and manufacturing costs capped at $335m this year – but the Japanese company will no longer fund those costs beyond 2022 and from 2023 onward will collect only a single-digit percentage royalty on Aduhelm sales worldwide.
Eisai’s tiered royalty will start at 2% and could rise as high as 8% under the amended agreement if annual sales hit $1bn, but at the current pace of Aduhelm sales, that seems unlikely to happen anytime soon. The amyloid-clearing antibody generated just $1.3m in sales in 2021 after winning accelerated approval from the US Food and Drug Administration in June as the first potentially disease-modifying drug for Alzheimer’s disease and Biogen expects minimal sales in 2022. (Also see "Biogen Resets Aduhelm Expectations, Expects Longer, Slower Path To Significant Sales" - Scrip, 3 Feb, 2022.)
Prescriber skepticism about mixed-pivotal trial results for Aduhelm and a preliminary decision by the Centers for Medicare & Medicaid Services (CMS) to cover the therapy’s cost only for patients enrolled in certain clinical trials has resulted in limited prescribing and reimbursement for the product to date. (Also see "Could Aduhelm Be Taken Off Market If CMS Proposal Stands? ‘Everything Is On The Table,’ Biogen Says" - Scrip, 13 Jan, 2022.)
Biogen’s final decision-making rights on Aduhelm have converted to sole decision-making and commercialization rights worldwide under the amended agreement with Eisai. Biogen will have full financial responsibility for development, commercialization and manufacturing starting in 2023.
However, the companies will continue to jointly develop and commercialize the amyloid protofibril-clearing antibody lecanemab – currently in Phase III clinical trials – with Eisai retaining final decision-making authority on development and regulatory submissions globally.
Eisai and Biogen will co-commercialize and co-promote lecanemab, with Eisai booking sales and Biogen reflecting its 50% share of profits and losses in its earnings statements. The only change to the companies’ agreement pertaining to lecanemab is that Biogen will manufacture the antibody at its Solothurn, Switzerland facility for 10 years instead of five.
The companies’ joint statement says that their amended agreement “will increase operational efficiency and agility in addressing market developments, including the final determination of CMS coverage on Aduhelm.”
Biogen, Eisai, patient groups and others are lobbying CMS to reconsider its draft national coverage determination (NCD) for Aduhelm and other amyloid-clearing therapies, first issued in January. (Also see "Medicare Draft NCD For Alzheimer's Drugs: When 'Reasonable And Necessary' And 'Safe And Effective' No Longer Align" - Pink Sheet, 11 Jan, 2022.) The final NCD is due in April and both proponents and opponents of Medicare coverage for Aduhelm have emerged. (Also see "Medicare And Alzheimer's Drugs: Grassroots Campaign Opposing Coverage Aims To ‘Take On Big Pharma’" - Pink Sheet, 14 Mar, 2022.)
Despite the controversy over Medicare coverage and Aduhelm’s accelerated approval based on biomarker data showing that the antibody cleared amyloid from the brains of Alzheimer’s patients, Eisai still plans to file for accelerated approval of lecanemab based on Phase II results. (Also see "Eisai Bets On Accelerated Approval For Biogen-Partnered Lecanemab" - Scrip, 28 Sep, 2021.) The company intends to complete the rolling submission of its biologics license application during the first quarter of its fiscal year, which begins on 1 April.
Eisai CEO Haruo Naito said in the company’s joint statement with Biogen about the partners’ new Alzheimer’s deal terms that “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.”