July 1, 2021

Strengthen the Lineup of ALS Treatments in the U.S.

EXSERVANTM (RILUZOLE) IS NOW AVAILABLE
IN THE U.S. FOR THE TREATMENT OF ALS
Mitsubishi Tanabe Pharma Corporation (MTPC) (Head Office: Osaka; President &Representative Director, CEO: Hiroaki Ueno), announced today that Mitsubishi
Tanabe Pharma America, Inc. (MTPA) (Head Office: NJ, U.S.; President: AtsushiFujimoto) launched EXSERVAN™ (riluzole), an oral film formulation of riluzole forthe treatment of amyotrophic lateral sclerosis (ALS) in the U.S.
ALS is an idiopathic neurodegenerative disease in which motor
neurons selectively degenerate and vanish. Muscle strength declines
throughout the entire body, including the limb, facial, andrespiratory muscles, and muscular atrophy progress.

EXSERVAN™, which quickly dissolves on top of the tongue, wasdeveloped to meet the needs of people with ALS, including those
who have difficulty swallowing some medications and is taken twice a day.
The U.S. Food and Drug Administration (FDA) approved EXSERVAN™ in November
2019 for the treatment of ALS.
Following RADICAVA® (edaravone) for the treatment of ALS, MTPC are currently
conducting global development of MT-1186 (oral suspension formulation ofRadicava).

In addition to EXSERVAN™ lineup, MTPC group aims to contribute to the treatmentof ALS disease while increasing treatment options for as many patients as possiblearound the world who are fighting ALS.
Press release from Mitsubishi Tanabe Pharma America, Inc.
™

Mitsubishi Tanabe Pharma America announces EXSERVAN (RILUZOLE) is now available
in the U.S. for the Treatment of ALS

Mitsubishi Tanabe Pharma CorporationCommunication Crossroads Department
Media contacts: TEL: +81 6 6205 5119

1 / 2<Reference>■ About Exservan™ (riluzole oral film)
Exservan, an oral film formulation of riluzole, was developed by
Aquestive

usingits

PharmFilm®

innovative

drugdelivery

technology. The oral film is placed on the patientʼs tongue andquickly dissolves without the need for liquids or food. RILUTEK®
(riluzole) tablets were the reference product during the oral
film development. Oral film riluzole was approved by the U.S.

＜how to take Exservan /image＞

Food and Drug Administration (FDA) in November 2019.

■ 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. In
Japan, it is being marketed under the product name RADICUT®. Edaravone has theeffect 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, China in July 2019 and Indonesia in July 2020.
MTPC are conducting a global Phase 3 clinical trial of MT-1186 (A01), an oralsuspension formulation of edaravone. MTPC received the Fast Track designation*
regarding MT-1186 in October 2019.

■ About Mitsubishi Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is awholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporationʼs (MTPC) 100
percent owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America,Inc. It was established by MTPC to commercialize approved pharmaceuticalproducts in North America.

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