November 15th, 2018

Mitsubishi Tanabe Pharma to present New data on
Investigational Oral Suspension of Edaravone for ALS
at 29th International Symposium on ALS/MND
Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Osaka; President &Representative Director, CEO: Masayuki Mitsuka), announced today that MTPC will
present pharmacokinetic (PK) data on an investigational oral suspension
formulation of edaravone for the treatment of ALS at the 29th International
Symposium on ALS/MND being held December 7-9 in Glasgow, Scotland.
Edaravone (US name: RADICAVA®; Japan names: RADICUT® Injection 30mg andRADICUT® BAG for I.V. Infusion 30mg) was approved for an indication ofamyotrophic lateral sclerosis (ALS) on June 2015, in Japan. Afterwards it wasapproved in Korea, US and Canada. It has been commercialized in the US by
Mitsubishi Tanabe Pharma America, Inc. (MTPA), MTPC’s US sales subsidiary sinceAugust 2017.
Now the intravenous (IV) formulation of edaravone is a treatment option,
therefore MTPC focused on the development of the oral formulation which aburden of the treatment to patients could be largely reduced. MTPC is working
hard to go forward the phase I clinical trial of the oral suspension which is easy totake in consideration of the situation that there are not few patients withdysphagia.
The initial Phase I dose-ranging PK study confirmed that a single oral dose ofedaravone has a similar PK profile when compared to IV infusion. No new safety
findings were observed relative to IV infusion. The latest results will be presented
at the upcoming Symposium.
Mitsubishi Tanabe Pharma will strive to deliver a beneficial new therapy option topatients fighting against ALS all over the world.

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

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<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, Labor and Welfare inApril 2001 as a treatment agent for the acute stage of cerebral infarction. In Japan,
it is being marketed under the product name RADICUT®. Edaravone has the effectof 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 effectof scavenging free radicals, which increase in ALS, protecting motor neurons fromoxidative stress, and delaying the decline in muscle strength and the progress ofmuscular 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. MTPC
filed for edaravone to EMA and Swissmedic.

■ About International Symposium on ALS/MND

International Symposium on ALS/MND is the conference to foster strong
collaboration between leading researchers around the world, and sharing newunderstanding of ALS and MND as rapidly as possible. Each year, the Symposium
attracts the global MND research community. The 29th International Symposium
will take place in Glasgow, UK.

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