June 1, 2022
Launch of DYSVAL® capsules 40mg
for Treatment of Tardive Dyskinesia in Japan
Mitsubishi Tanabe Pharma Corporation
Mitsubishi Tanabe Pharma Corporation (Head Office: Chuo-ku, Osaka; Representative
Director: Hiroaki Ueno; hereinafter, “MTPC”), a member of the Mitsubishi ChemicalHoldings Group, announced today that MTPC is launching DYSVAL® capsules 40mg
(generic name: valbenazine, DYSVAL) (the vesicular monoamine transporter type 2(VMAT2) inhibitor) for the treatment of tardive dyskinesia in Japan following the inclusionof DYSVAL in the NHI drug price listing on May 25,2022.
As the first drug approved in Japan for the treatment of tardive dyskinesia, DYSVAL
would provide patients with a once-daily treatment option in Japan.
Tardive dyskinesia is a neurologic disorder characterized by involuntary movement.
Symptoms include uncontrollable, abnormal and repetitive movements of the tongue,lips, jaw, face, the extremities, and torso. Severe cases can lead to dysphagia orrespiratory distress, which can be serious in some patients. Tardive dyskinesia arises
from the long-term administration of antipsychotic drugs or other drugs. Increased
sensitivity of dopamine receptors is considered to be a causal factor.
MTPC wants to help patients who are suffering from tardive dyskinesia symptoms toestablish an environment where they can receive treatment for their primary disease andalso face treatment for tardive dyskinesia.
MTPC and Janssen Pharmaceutical K.K. (Janssen) with strengths in the neurology areaconcluded a co-promotion agreement concerning DYSVAL in Japan, in November 2021.
Janssen will be responsible for the distribution of DYSVAL, and MTPC, Janssen andYoshitomiyakuhin Corporation will jointly provide appropriate information to healthcare
professionals in Japan.
MTPC Group, in collaboration with Janssen, is committed to contributing to the treatmentof patients with tardive dyskinesia by providing prompt, thorough information provision.
Mitsubishi Chemical Holdings Group
Corporate Communications Div.
Osaka Corporate Communications Dept.
Media contacts: [+81] (0)6-6205-5119
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Product NameDYSVAL® Capsules 40mg (DYSVAL® capsules)

JAN

Valbenazine

Indication

Tardive dyskinesia

DosageOnce daily, starting dose is 40mg, and maximum dose is80mg.

Packaging

40mg 100 capsules [10 capsules (PTP) ×10]

Retail Price

40mg 2331.20yen/one capsule

Approval (Japan)

March 28,2022

HVL Listing

May 25, 2022

Release (Japan)

June 1, 2022

Manufacturer

Mitsubishi Tanabe Pharma Corporation

Distributor and Co-Promoter

Janssen Pharmaceutical K.K.

Co-Promoter

Yoshitomiyakuhin Corporation■About Valbenazine
Valbenazine inhibits VMAT2, which is located in nerve endings, thereby reducing theuptake of dopamine and other neurotransmitters into presynaptic vesicles andnormalizing the function of dopaminergic neurons associated with occurrence ofinvoluntary movement.
In the U.S., approval for an indication of tardive dyskinesia has been received by
Neurocrine Biosciences in April 2017.
In 2015, MTPC exclusively licensed the development and commercialization rights for
Valbenazine in Japan from Neurocrine Biosciences, Inc. (U.S.) and received approval ofValbenazine for the indication of tardive dyskinesia in Singapore, Thailand, South Korea,and Indonesia in May, August, November, and December 2021, respectively, and theapplication for tardive dyskinesia is currently under review by the authority in Malaysia.

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