Shionogi completes acquisition of rights to ALS drug Radicava
Company pledges continuity of care for patients
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- Shionogi acquired global rights to Radicava (edaravone) for ALS from Tanabe Pharma.
- Radicava treats ALS by neutralizing toxic oxygen molecules to slow progression.
- Shionogi commits to ensuring continuity of care and supply for ALS patients using Radicava.
Shionogi has completed its acquisition of global rights to Radicava and Radicava ORS, two edaravone formulations approved to treat amyotrophic lateral sclerosis (ALS), from Tanabe Pharma, finalizing a deal announced late last year.
When it signed the agreement, Tanabe said it would establish a U.S.-based company to hold the rights to Radicava and Radicava ORS, which Shionogi agreed to acquire as a wholly owned subsidiary for about $2.5 billion, plus potential royalties tied to future sales. With the deal now complete, full ownership of all rights to both Radicava formulations — including intellectual property and marketing rights — has been transferred to Shionogi in major countries and regions. Rights in additional countries and regions will be transferred sequentially.
“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,” Isao Teshirogi, PhD, CEO of Shionogi, said in a company press release.
The acquisition will bring more than 100 team members from Tanabe Pharma America (TPA), a wholly owned U.S. subsidiary of Tanabe Pharma, into Shionogi, along with Radicava programs and platforms. This is intended to ensure continuity of care for people living with ALS.
“We are excited to continue growing our rare disease capabilities with the addition of the talented cross-functional team from Tanabe,” said Nathan McCutcheon, president and CEO of Shionogi’s U.S. subsidiary. “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.”
Aiming for a smooth transition
“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, Teshirogi said. “We take this responsibility seriously and commit to providing continuity of care and continued innovation in ALS and rare disease.”
Tanabe said the transition has been planned and executed to minimize disruption to patient care and access. Product availability and supply chain are expected to remain unchanged, and all existing patient support services will continue to operate as before. Processes for reporting side effects and key points of contact for healthcare providers and patients will also remain in place.
“We are incredibly proud of the achievements we have accomplished in bringing Radicava to patients living with ALS, and today marks both a meaningful milestone and an exciting new beginning,” Yasutoshi Kawakami, president of TPA, said in a press release from that company. “This finalization allows TPA to focus on driving discoveries through innovative science with a late-stage pipeline of investigational treatments for difficult-to-treat diseases.”
A progressive neurodegenerative disease, ALS occurs due to the loss of motor neurons, the nerve cells that control voluntary movements. While the exact causes of ALS are not fully understood, the excessive production of toxic oxygen-containing molecules is believed to contribute to nerve cell damage that can ultimately lead to their death.
Radicava, an intravenous (into-the-vein) formulation, and Radicava ORS, an oral suspension, both contain edaravone, a compound that helps neutralize toxic oxygen-containing molecules. By reducing levels of these molecules, the therapies may prevent motor neuron damage and slow disease progression.
Clinical data suggest that both formulations can slow functional decline and may help adults with ALS live longer. Together, Radicava and Radicava ORS have been used to treat more than 22,000 people with ALS in the U.S, according to Shionogi.
“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,” McCutcheon said.
