April 10, 2018
To ALS patients in the world, we hope to deliver Japan-originated ALS treatment

Health Canada accepts our filing for Edaravone to treat ALS
and we established commercializing company in Canada
Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Osaka; President &Representative Director, CEO: Masayuki Mitsuka), announced today that the HealthCanada has accepted MTPC’s filing for edaravone (Japan name: RADICUT® BAG forI.V. Infusion 30mg. US name: RADICAVA®) an intravenous treatment foramyotrophic lateral sclerosis (ALS), a rapidly progressive neurological disease onApril 6, 2018. And Mitsubishi Tanabe Pharma America Inc. (MTPA) has established
Mitsubishi Tanabe Pharma Canada, Inc. (MTP-CA) on March 27, with a view tocommercializing approved pharmaceutical products in Canada as a wholly-owned
subsidiary of MTPA.
Health Canada granted Priority Review are subject to a regulatory review target of180 days from the date Health Canada accepts MTPC’s filing for edaravone.
ALS is an idiopathic neurodegenerative disease in which motor neurons selectivelydegenerate and vanish. Muscle strength declines throughout the entire body,including the limb, facial, and respiratory muscles, and muscular atrophy progress.
While the cause for the majority of cases is not well understood but may involve
genetic and environmental factors. It is one of the most well-known neuromusculardiseases, affecting approximately two in 100,000 people worldwide. As many as
3,000 people are estimated to be affected by ALS in Canada.
MTPC accomplished the clinical research program in patients diagnosed with ALS in Japan.
Edaravone was approved for use as a treatment for ALS in Japan, June 2015, South
Korea, December 2015 and the U.S., May 2017.
MTPC will strive to deliver edaravone to patients fighting against ALS all over theworld.
< Mitsubishi Tanabe Pharma Canada, Inc. >・ Name：Mitsubishi Tanabe Pharma Canada Inc.

・ Address:

Ontario, Canada

・ Managing Director:

Atsushi Fujimoto

・ Establishment:

27 March, 2018

・ Share Capital:

4 million Canada Dollar

・ Shareholder:

Mitsubishi Tanabe Pharma America Inc. (100%)・ Main Activities:

Marketing of pharmaceutical products in Canada
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Mitsubishi Tanabe Pharma Corporation
Corporate Communications Department
Media contacts: TEL:+81 6 6205 5119
Investor contacts: TEL:+81 6 6205 5110

<Reference>■ About edaravone
Edaravone is a free-radical scavenger that was discovered by Mitsubishi Tanabe
Pharma. It was approved by the Ministry of Health, Labor and Welfare in April 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 effect ofscavenging free radicals that arise accompanying cerebral ischemia, controlling thelipid peroxidation reaction, and protecting neurons in the region of the ischemia andthe surrounding region. Accordingly, it is thought that edaravone has the effect ofscavenging free radicals, which increase in ALS, protecting motor neurons fromoxidative stress, and delaying the decline in muscle strength and the progress ofmuscular atrophy.

■ About Mitsubishi Tanabe Pharma America Inc. (MTPA)
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America (MTPA) is a whollyowned subsidiary of Mitsubishi Tanabe Pharma Corporation’s (MTPC) 100 percent
owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc.
MTPA is dedicated to delivering innovative products that address the unmet medicalneeds of patients in North America. It was established by MTPC to commercialize
approved pharmaceutical products in North America with plans to expand its productline through collaborations with partners. Mitsubishi Tanabe Pharma Canada (MTPCA) is a wholly-owned subsidiary of MTPA. For more information, please visit www.mtpharma-america.com or follow us on Twitter at https://twitter.com/MTPharmaUS.

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