Shionogi & Co., Ltd. has completed its acquisition of global rights to RADICAVA (edaravone), strengthening its position in rare diseases and expanding its commercial footprint in treatments for Amyotrophic Lateral Sclerosis.
The deal, valued at $2.5 billion, transfers intellectual property and sales rights from Tanabe Pharma Corporation to Shionogi. The company said the integration of more than 100 team members and related infrastructure was completed immediately to ensure continuity of care for ALS patients.
RADICAVA is approved by the U.S. Food and Drug Administration and other regulators worldwide. It has been used to treat more than 22,000 ALS patients in the United States, including both intravenous and oral formulations.
Shionogi expects the transaction to be immediately accretive in fiscal year 2026, contributing approximately $700 million in annual global sales. The acquisition also establishes a commercial platform in rare diseases to support future product launches.
RADICAVA ORS, the oral suspension version approved in 2022, received orphan drug exclusivity in 2024 due to its contribution to patient care by offering a more convenient alternative to IV administration. The treatment is administered in cycles and is designed to help slow disease progression in ALS, a condition with limited therapeutic options and no known cure.
ALS is a progressive neurodegenerative disease characterized by the loss of motor neurons, leading to muscle weakness, respiratory decline, and ultimately reduced life expectancy. With an incidence of roughly 1 to 2 cases per 100,000 people globally, it remains a rare disease with significant unmet medical need.
The acquisition aligns with Shionogi’s broader strategy to expand its rare disease portfolio, which also includes programs targeting conditions such as Fragile X syndrome, Jordan’s syndrome, and Pompe disease.
KEY QUOTES:
“By completing the acquisition of RADICAVA we are demonstrating progress toward our 2030 Vision and fulfilling our commitment to supply the best possible medicines to protect the health and wellbeing of the patients we serve. With RADICAVA we are not only acquiring a medication, we are also acquiring an established rare disease capability and assuming responsibility for a relationship with the ALS community. We take this responsibility seriously and commit to providing continuity of care and continued innovation in ALS and rare disease.”
Isao Teshirogi, Ph.D., CEO of Shionogi & Co., Ltd.
“RADICAVA is an important option for people with ALS and we are committed to serving the community’s needs today and working toward future innovations in care. We are excited to continue growing our rare disease capabilities with the addition of the talented cross-functional team from Tanabe. The RADICAVA team will complement our efforts to establish a best-in-class rare disease franchise in the U.S. and ensure readiness to deliver future innovations to patients.”
Nathan McCutcheon, President and CEO of Shionogi Inc.