Shionogi strengthens rare disease strategy with planned Radicava deal
ALS therapy acquisition adds ready-made U.S. platform for future launches
- Shionogi moves to acquire global Radicava rights for ALS.
- Edaravone therapies target oxidative stress to slow ALS decline.
- The deal strengthens Shionogi’s rare disease focus and supports continued patient access.
Tanabe Pharma plans to establish a new U.S.-based company to hold the global rights to Radicava and Radicava ORS, two edaravone formulations approved to treat amyotrophic lateral sclerosis (ALS), which Shionogi plans to acquire and operate as a wholly owned subsidiary.
“We are pleased to welcome Radicava to Shionogi,” Isao Teshirogi, PhD, Shionogi’s president and CEO, said in a company press release. “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.”
Under an agreement signed in December and expected to close on or after April 1, Shionogi will fully own the new company responsible for marketing available Radicava formulations, which Teshirogi calls a “critically important medicine.” Tanabe Pharma will receive a $2.5 billion upfront payment, along with royalties tied to future sales.
“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 of Shionogi’s U.S. subsidiary.
What happens in ALS and how Radicava works
ALS is a progressive neurodegenerative disease marked by the loss of motor neurons, the nerve cells that control voluntary movements. Multiple factors contribute to this damage, including the excessive production of toxic oxygen-containing molecules.
Radicava ORS, an oral suspension, and Radicava, an intravenous formulation, both contain edaravone, a compound that helps neutralize toxic oxygen-containing molecules. By reducing the levels of these toxic molecules, these therapies may help protect motor neurons and slow disease progression.
Accumulating clinical data suggest that both Radicava and Radicava ORS can slow functional decline and help adults with ALS live longer. Together, these two formulations have been used to treat more than 20,000 people with ALS in the U.S.
“We recognize the significant responsibility that comes with a widely utilized breakthrough medicine and will be conscientious stewards of this important drug,” Teshirogi said.
Shionogi’s strategy centers on expanding its rare disease portfolio, with a focus on conditions that have major unmet needs, including fragile X syndrome and Pompe disease.
The planned deal adds a ready-made U.S. commercial infrastructure, which could help Shionogi bring future rare disease medicines to patients more efficiently once approved.
“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,” said McCutcheon.
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