May 30, 2019

Withdrawal of Marketing Authorization Application ofedaravone for ALS in the European Union
Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Osaka, Japan;President & Representative Director, CEO: Masayuki Mitsuka), announced today thewithdrawal of the Marketing Authorization Application (MAA) of edaravone for thetreatment of amyotrophic lateral sclerosis (ALS) in the European Union (EU). The
MAA of edaravone was submitted on 30 Apr 2018 by Mitsubishi Tanabe Pharma
Europe Ltd. who are the MTPC R&D subsidiary in the EU. Edaravone (Japan name:RADICUT® BAG for I.V. Infusion 30mg.) is an intravenous treatment for ALS, arapidly progressive neurological disease.
Edaravone has been approved for treatment of ALS in Japan, South Korea, UnitedStates, Canada and Switzerland, based on the results from a six-month placebocontrolled study in Japanese ALS patients, in which the primary endpoint was theALS functional rating scale (ALSFRS-R), a measurement of functional loss in dailyliving activities in ALS patients. The study demonstrated that edaravone significantly
slowed functional loss compared to placebo with 2.49 points difference in ALSFRSR total score (equivalent to 33% difference) after six months treatment*.
*Reference: Package Inserts of RADICUT®
However, in accord with the European Medicine Agency’s (EMA) development
guideline for ALS, the EMA’s Committee for Medicinal Products for Human Use(CHMP) maintains the position that an additional, long-term, placebo-controlled
study of survival (time to death or permanent ventilation support/tracheostomy) ofat least 12 months duration would be required to obtain the data necessary for
regulatory approval in the EU. MTPC believes that the efficacy and safety ofedaravone has been demonstrated and an additional long-term placebo-controlled
study is unwarranted. Therefore, MTPC has made the difficult decision to withdraw
the MAA for edaravone. MTPC will now carefully consider the future options foredaravone in the EU.
Mitsubishi Tanabe Pharma Group will continue to make every effort to deliver
edaravone to patients suffering from ALS worldwide by increasing, as far as possible,
the number of countries with regulatory approvals based on the current data. MTPC1/2

is fully committed to providing treatment for ALS patients, including the rapid
development of an oral formulation of edaravone as an option to supplement theexisting IV formulation.
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 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.

■ About Mitsubishi Tanabe Pharma Europe Ltd.(MTPE)
Based in London, UK, Mitsubishi Tanabe Pharma Europe Ltd. is a wholly-owned
subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). Mitsubishi Tanabe
Pharma Europe Ltd. is dedicated to research and develop innovative pharmaceuticalproducts that address the unmet medical needs of patients in EU.
http://www.mt-pharma-eu.com/

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