November 25, 2019

Mitsubishi Tanabe Pharma Announces
the Start of a Phase 3 Clinical Trial using
Oral Suspension of Edaravone for ALS
Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Osaka; President &Representative Director, CEO: Masayuki Mitsuka), announced today that its
research and development subsidiary in U.S., Mitsubishi Tanabe Pharma
Development America, Inc. (MTDA), has started a global Phase 3 clinical trial ofan oral suspension formulation of edaravone (U.S. name: RADICAVA®; Japan
names: RADICUT® Injection 30mg and RADICUT® BAG for I.V. Infusion 30mg) for
the treatment of ALS.
This clinical trial will evaluate 150 people with ALS in U.S., Canada, Europe andJapan over the course of 48 weeks. MTPC is planning to submit 24-week data firstto relevant authorities.
MTDA received the Fast Track designation* regarding this product in October
2019. MTPC is targeting the product launch in FY 2021 in U.S..
MTPC is focused on the development of the oral suspension formulation to provide
an alternative dosing administration option for ALS patients, where there is asignificant unmet need.
Edaravone was approved with intravenous formulation for an indication ofamyotrophic lateral sclerosis (ALS) on June 2015, in Japan. Afterwards it wasapproved in Korea, U.S., Canada, Switzerland and China.
Mitsubishi Tanabe Pharma Group will strive to deliver a new therapy option topatients fighting against ALS from locations around the world.
*This designation allows the Oral Suspension of Edaravone Development Team to have increased
dialogue with the FDA regarding the development program at key time points.

Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Media contacts: TEL:+81 6 6205 5119
Investor contacts: TEL:+81 6 6205 5110

1/2<Reference>■ About edaravone
Edaravone is a free-radical scavenger that was discovered by Mitsubishi Tanabe
Pharma. It was approved by the Japanese Ministry of Health, Labour and Welfare
in April 2001 as a treatment agent for the acute stage of cerebral infarction. InJapan, it is being marketed under the product name RADICUT®. Edaravone has
the effect of scavenging free radicals that arise accompanying cerebral ischemia,
controlling the lipid peroxidation reaction, and protecting neurons in the region of
the ischemia and the surrounding region. Accordingly, 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 theprogress of muscular atrophy.
For use as a treatment for ALS, edaravone was approved in Japan in June 2015,
South Korea in December 2015, US in May 2017, Canada in October 2018,
Switzerland in January 2019 and China in July 2019.

■ Mitsubishi Tanabe Pharma Development America, Inc.
The U.S. headquarters of Mitsubishi Tanabe Pharma Development America, Inc.
(MTDA) is located in Jersey City, New Jersey. MTDA is a wholly-owned subsidiaryof Mitsubishi Tanabe Pharma Corporation’s 100 percent-owned U.S. holdingcompany, Mitsubishi Tanabe Pharma Holdings America, Inc. MTDA obtained theregulatory approval of RADICAVA ® I.V. the only treatment option for ALS in morethan 20 years in the United States. MTDA is dedicated to research and develop
innovative pharmaceutical products that address the unmet medical needs ofpatients. http://mt-pharma-development-america.com/

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