February 6th, 2019

Swissmedic approves RADICAVA,
Japan-originated ALS treatment
Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Osaka; President &Representative Director, CEO: Masayuki Mitsuka), announced today that Edaravone(Swiss name: RADICAVA®; Japan names: RADICUT® BAG for I.V. Infusion 30mg)
was approved by the Swissmedic for an indication of amyotrophic lateral sclerosis(ALS), a rapidly progressive, neurodegenerative disease on January 31st. Mitsubishi
Tanabe Pharma GmbH (MTPD) as a subsidiary of MTPC has filed to Swissmedic andwill commercialize RADICAVA®.
The approval of Swissmedic was based on a clinical trial which the primary endpoint
was a measurement utilizing the ALS Functional Rating Scale-Revised (ALSFRS-R),
a validated rating instrument for monitoring the progression of disability in patientswith ALS in Japan*.
Now there are limited treatment options to treat ALS, therefore MTPC would like tomeet ALS patients demand of RADICAVA® in Switzerland.
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.
Initial symptoms can be subtle, and accordingly it can take 12 to 14 months to beaccurately diagnosed. It is one of the most well-known neuromuscular diseases,
affecting approximately two in 100,000 people worldwide. An estimated 600 Swisscurrently are living with ALS**.
Mitsubishi Tanabe Pharma will strive to deliver edaravone to patients fighting against
ALS all over the world.
* Refer to the package insert (clinical trial results) for RADICUT® inj. 30mg ampule and RADICUT®
BAG for I.V. Infusion 30mg**Kathi Schweikert. Amyotrophe Lateralsklerose. Swiss Medical Forum 2015;15(46):1068–1073.
http://www.als-schweiz.ch/__/frontend/handler/document.php?id=534&type=42

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.

■ Mitsubishi Tanabe Pharma GmbH (MTPD)
Headquartered in Dusseldorf, Germany, Mitsubishi Tanabe Pharma GmbH has beenfounded in 2003 as a subsidiary of Mitsubishi Pharma Europe Ltd. (London/UK).
The company in Switzerland, based in Zurich, focuses not only on Radicava®, butalsoonmarketingthedirect

thrombininhibitor,

Argatra®

(argatrobanmonohydrate).

■ About Mitsubishi Tanabe Pharma Europe Ltd.
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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