Shionogi & Co., Ltd. announced that its Board of Directors, at a meeting held on December 22, 2025, resolved to acquire a newly established company that Tanabe Pharma Corporation will create to hold the rights to RADICAVA ORS®  and IV RADICAVA. Tanabe Pharma plans to form this new entity, and Shionogi intends to purchase 100% of its shares. The agreement between Shionogi and Tanabe Pharma was signed this afternoon. As part of the transaction, a new business company established by Tanabe for RADICAVA in the U.S. will become a wholly owned subsidiary of Shionogi Inc.

RADICAVA ORS is approved by the U.S. Food and Drug Administration (FDA) and other regulatory agencies around the world for the treatment of amyotrophic lateral sclerosis (ALS), a progressive neurodegenerative disease for which there is no cure and few treatment options. RADICAVA ORS, along with a previously available intravenous formulation, have been used to treat more than 20,000 people with ALS in the U.S. to date.

“We are pleased to welcome RADICAVA to Shionogi. This critically important medicine was created to reduce the devastating burden of ALS, and we are honored to assume responsibility for it and to sustain and grow the relationships Tanabe Pharma has established with the patient and healthcare communities in the U.S.,” said Isao Teshirogi, Ph.D., CEO of Shionogi. “We recognize the significant responsibility that comes with a widely utilized breakthrough medicine and will be conscientious stewards of this important drug.”

“We are very excited to welcome this team and outstanding medicine to our U.S. business. This planned acquisition will solidify our strategic focus in rare disease and immediately add capabilities to ensure long term success in this important category,” said Nathan McCutcheon, President and CEO, Shionogi Inc. “Going forward, this infrastructure will support future launches in rare disease including Shionogi’s development programs in Fragile X syndrome, Jordan’s Syndrome and Pompe disease.”

Purpose and Background of the Acquisition

Shionogi has identified “Contributing to a Healthy and Enriched Life” as a materiality (key issue) to address in order to create new value for customers and society. To realize a society where everyone can live vibrantly and true to themselves, we have designated disease areas with significant anticipated future unmet needs—classified as “high social impact QOL disorders” (such as sleep disorders, hearing loss, and rare diseases)—as priority areas for research and development, and we are advancing initiatives to deliver solutions.

Within the category of high social impact QOL disorders, Shionogi is establishing a presence in rare disease through existing research programs in Fragile X syndrome, Jordan’s Syndrome and Pompe disease. In addition to potential early phase rare disease assets that recently became part of Shionogi’s pipeline,1 this acquisition creates the commercial infrastructure to accelerate the delivery of new rare disease medicines once regulatory approvals are obtained.

Key Assets and Capabilities to Be Secured Through This Acquisition

• Acquisition of all rights, including global marketing rights for RADICAVA ORS® and IV RADICAVA
• Establishing a strong rare disease commercial platform in the U.S. market
• Integration of talent and business expertise in the rare disease area

Under this agreement, Shionogi will pay a lump sum of USD 2.5 billion to Tanabe Pharma through Shionogi Inc., upon completion of the procedures. Additionally, Shionogi may pay a royalty on future sales, subject to certain conditions. Going forward, the RADICAVA ORS® and IV RADICAVA business company will commence operations as a wholly owned subsidiary of Shionogi Inc.

1. Resolution Date of Board Meeting
2. December 22, 2025
3. Agreement Date
4. December 22, 2025
5. Target Closing Date
6. On or after April 1, 2026 (Scheduled)
7. Future Prospects

The impact of making this company a wholly owned subsidiary on Shionogi’s consolidated financial results for the fiscal year ending March 31, 2026 is expected to be immaterial.
Advisors

Cleary Gottlieb Steen & Hamilton LLP served as legal advisor to Shionogi. Centerview Partners LLC served as lead financial advisor and Ropes & Gray LLP served as legal advisor to Tanabe. Goldman Sachs also provided financial advice to Tanabe. Bank of America served as financial advisor to Bain Capital.

Source: businesswire.com