Mitsubishi Tanabe Pharma Corporation and Daiichi Sankyo Company Limited have announced that they have concluded a licensing agreement covering commercialization rights in Brazil for an intravenous infusion formulation of edaravone, a treatment agent for amyotrophic lateral sclerosis (ALS).
In addition, Mitsubishi Tanabe Pharma has granted Daiichi Sankyo rights of first negotiations for commercialization for this dosage form of the drug in countries in Central and South America other than Brazil as well as for other additional dosage forms of this drug in countries in Central and South America, including Brazil.
Under this agreement, Daiichi Sankyo will file a regulatory application in Brazil for edaravone through its local subsidiary, and will commercialize the product in Brazil upon the approval.
Edaravone is a free radical scavenger that was discovered by Mitsubishi Tanabe Pharma. It is thought that edaravone has the effect of scavenging free radicals, which increase in ALS, protecting motor neurons from oxidative stress, and delaying the decline in muscle strength and the progress of muscular atrophy.
In June 2015, edaravone was approved in Japan as a treatment agent for controlling the progress of functional damage in ALS. Edaravone has currently been approved in South Korea, the U.S., Canada, Switzerland, and China.
To maximize the value of edaravone, Mitsubishi Tanabe Pharma is working to increase the countries where it is available and is advancing development of an oral preparation as a new administration route. This licensing agreement is expected to provide a foundation for the expansion of the countries where edaravone is available in Central and South America.