March 28, 2022®

Regulatory Approval of DYSVAL capsules 40mg
for Treatment of Tardive Dyskinesia in Japan
Mitsubishi Tanabe Pharma Corporation (MTPC, Head Office: Chuo-ku, Osaka;
President & Representative Director: Hiroaki Ueno) obtained the regulatory approvalof the vesicular monoamine transporter type 2 (VMAT2) inhibitor, DYSVAL®
capsules 40mg (DYSVAL, development code: MT-5199, generic name: valbenazine)
for the treatment of tardive dyskinesia from the Ministry of Health, Labour andWelfare on March 28, 2022.
As the first drug approved in Japan for the treatment of tardive dyskinesia, MTPC
believes that DYSVAL offers a new treatment option for tardive dyskinesia.
Tardive dyskinesia is a neurologic disorder characterized by involuntary movement.
Symptoms include uncontrollable, abnormal and repetitive movements of thetongue, lips, jaw, face, the extremities, and torso. Severe cases can lead todysphagia or respiratory distress, which can be serious in some patients. Tardive
dyskinesia arises from the long-term administration of antipsychotic drugs or otherdrugs. Increased sensitivity of dopamine receptors is considered to be a causal
factor.
In 2015, MTPC exclusively licensed the development and commercialization rights
for this product in Japan and certain other Asian countries from Neurocrine
Biosciences, Inc. (U.S.). MTPC conducted the phase 2/3 clinical study (J-KINECT
study: MT-5199-J02) in Japan from June 2017 to confirm the efficacy and safety ofDYSVAL. J-KINECT study showed a significant improvement in the primary efficacy
endpoint of the mean change from baseline in the Abnormal Involuntary Movement
Rating Scale (AIMS) total score at Week 6 of treatment with DYSVAL compared toplacebo. The persistence of efficacy was also shown in the AIMS total score at Week
48. In addition, DYSVAL was generally well-tolerated.
MTPC received approval of this product for the indication of tardive dyskinesia in
Singapore, Thailand, South Korea, and Indonesia in May, August, November, andDecember 2021, respectively, and the application for tardive dyskinesia is currently
under review by the authority in Malaysia.
MTPC Group will continue to advance R & D activities so that we can deliver the best
pharmaceutical products for diseases with unmet needs as soon as possible.
Mitsubishi Tanabe Pharma Corporation
Communication Crossroads Department
Media contacts: TEL: +81 6 6205 5119

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About valbenazine
Valbenazine inhibits VMAT2, which is located in nerve endings, thereby reducing
the uptake 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.
After MTPC obtains regulatory approval for this product in Japan, Janssen
Pharmaceutical K.K. will be responsible for distribution. Both companies will jointly
promote it (press release dated December 3, 2021).
About Neurocrine Biosciences
Neurocrine Biosciences is a neuroscience-focused, biopharmaceutical company witha simple purpose: to relieve suffering for people with great needs, but few options.
We are dedicated to discovering and developing life-changing treatments forpatients with under-addressed neurological, neuroendocrine and neuropsychiatricdisorders. The companyʼs diverse portfolio includes FDA-approved treatments for
tardive dyskinesia, Parkinsonʼs disease, endometriosis* and uterine fibroids*, aswell as over a dozen mid-to-late-stage clinical programs in multiple therapeuticareas. For three decades, we have applied our unique insight into neuroscience andthe interconnections between brain and body systems to treat complex conditions.
We relentlessly pursue medicines to ease the burden of debilitating diseases anddisorders, because you deserve brave science. For more information, visit
neurocrine.com, and follow the company on LinkedIn. (*in collaboration withAbbVie).

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