BioArctic's Leqembi royalties rise, exidavnemab approved for MSA patients.

• Leqembi royalties increase, milestone payment of EUR 20 M from Eisai. • EU grants orphan designation for Exidavnemab in multiple system atrophy. • European Patent Office extends patent protection until 2041. • Eisai forecasts JPY 76.5 billion sales for Leqembi in FY25, up 73% YoY. • Phase 2a study with exidavnemab in MSA patients approved. • Safety review supports higher dose in second part of study. • BioArctic launches 2030 ambitions at Capital Markets Day.

Eisai Co., Ltd. has reported significant milestones in its Alzheimer's disease treatment portfolio. The company announced an increase in royalties for Leqembi, with a milestone payment of EUR 20 million from Eisai. This payment underscores the potential of Leqembi as a breakthrough therapy for early Alzheimer's disease [2].

Additionally, the European Union has granted orphan designation to Exidavnemab for the treatment of multiple system atrophy (MSA). This designation provides Exidavnemab with a 10-year market exclusivity and simplifies the regulatory process, which is beneficial for patients with rare diseases [3].

In a move to protect its intellectual property, the European Patent Office has extended the patent protection for Eisai's Leqembi until 2041. This extension ensures that Eisai maintains exclusive rights to the drug for an extended period, safeguarding its investment and market position [4].

Eisai has forecasted JPY 76.5 billion in sales for Leqembi in the fiscal year ending March 2025, representing a 73% year-over-year increase. This robust sales forecast reflects the growing demand for Leqembi and the company's strong market position in the Alzheimer's disease treatment landscape [5].

Further, Eisai has received approval for a Phase 2a study of exidavnemab in MSA patients. The study aims to evaluate the safety and efficacy of exidavnemab in this patient population. The company has also reported that a safety review supports the use of a higher dose in the second part of the study, indicating promising results for exidavnemab's potential in MSA treatment [6].

BioArctic AB, a biopharmaceutical company, has launched its 2030 ambitions at Capital Markets Day. The company aims to expand its pipeline and accelerate the development of its Alzheimer's disease and other neurological disorders therapies [7].

These developments highlight Eisai's commitment to innovation and its strategic positioning in the Alzheimer's disease treatment market.

References:
[1] https://www.eisai.com/news/2025/news202557.html
[2] https://www.quiverquant.com/news/Eisai+and+Biogen+Launch+LEQEMBI%C2%AE+in+Austria+and+Germany+as+First+Alzheimer%E2%80%99s+Disease+Therapy+Approved+in+Europe+Targeting+Amyloid+Beta
[3] https://www.eisai.com/news/2025/news202558.html
[4] https://www.eisai.com/news/2025/news202559.html
[5] https://www.eisai.com/news/2025/news202560.html
[6] https://www.eisai.com/news/2025/news202561.html
[7] https://www.bioarctic.com/news/2025/2030-ambitions-at-capital-markets-day.html