October 8, 2021

Top-line data of J-KINECT Study,Phase 2/3 study in Japan of VMAT2 inhibitor MT-5199 in TD,
presented at the 31st annual meeting of the Japanese Society ofClinical Neuropsychopharmacology
Mitsubishi Tanabe Pharma Corporation (MTPC, Head Office: Chuo-ku, Osaka;
President & Representative Director: Hiroaki Ueno) presented top-line data of phase
2/3 clinical study in Japan (J-KINECT study) of MT-5199 (generic name:valbenazine), the vesicular monoamine transporter type 2 (VMAT2) inhibitor, insubjects with tardive dyskinesia (TD) at the 31st annual meeting of the JapaneseSociety of Clinical Neuropsychopharmacology from October 7 to October 8, 2021.
The J-KINECT study is a randomized, double-blind placebo-controlled study toconfirm the efficacy and safety of MT-5199 administered once daily for up to 48
weeks in patients with moderate or severe TD, and 253 patients received either MT5199 or placebo. In this presentation, the results from the placebo-controlled
double-blind period (up to 6 weeks of administration) were presented as top-line
data.
Title: Topline results of J-KINECT study, Phase 2/3 study of vesicular monoaminetransporter 2 (VMAT2) inhibitor MT-5199 in Japanese tardive dyskinesia patients

Primary Endpoint: The mean change from baseline in the Abnormal Involuntary
Movement Scale (AIMS) total score at Week 6 showed significant improvementin the MT-5199 group compared to the placebo group.

Secondary

endpoints:

The

proportionof

subjects

achieving≥50%

improvement from baseline in AIMS total score at Week 6 was significantly
higher in the MT-5199 group than that in the placebo group. The MT-5199
group showed a significant improvement in the Clinical Global Impression ofChange-Tardive Dyskinesia (CGI-TD) score at Week 6 compared with theplacebo group.
Safety: In the placebo-controlled double-blind period, the MT-5199 group wasgenerally well tolerated. Adverse events that occurred at a ≥ 5% higher
incidence in the MT-5199 group than in the placebo group were somnolence,salivary hypersecretion, malaise, schizophrenia, and tremor.

These results indicate that MT-5199 is generally well tolerated and improves TD
symptoms. The efficacy and safety results for 48 weeks treatment period in thisstudy will be presented at an academic conference in the near future.
1 / 2In 2015, MTPC exclusively licensed the development and commercialization rights
for MT-5199 in Japan and certain other Asian countries from Neurocrine BiosciencesInc. (U.S.), and since then, MTPC has been conducting development activities forMT-5199 within the licensed region.
In Japan, MTPC filed an application for marketing authorization of MT-5199 for thetreatment of TD with the Ministry of Health, Labour and Welfare in April 2021.
Moreover, in Singapore and Thailand, MT-5199 was approved in May 2021 andAugust 2021, respectively, and the applications have been filed and are currently
under review in Indonesia, Malaysia, and South Korea.
MTPC Group will continue to advance R&D activities so that we can deliver the best
possible pharmaceutical products as quickly as possible to many patients fighting
against diseases all over the world.
Mitsubishi Tanabe Pharma Corporation
Communication Crossroads Department
Media contacts: TEL: +81 6 6205 5119

<Reference>
About tardive dyskinesia
Tardive dyskinesia (TD) is a type of involuntary movements arising from the longterm administration of antipsychotic drugs or other drugs. Increased dopamine
sensitivity is considered to be a causal factor. Symptoms, which differ by patient,
are principally facial, but also in the extremities and torso. Involuntary movements
cause psychological and physical burden. Severe cases can lead to dysphagia orrespiratory distress. There is currently no approved treatment for TD in Japan.
About MT-5199
MT-5199 (generic name: valbenazine) inhibits VMAT2 (vesicular monoaminetransporter type 2), which is located in nerve endings, thereby reducing the uptakeof dopamine and other neurotransmitters into presynaptic vesicles and normalizing
the function of dopaminergic neurons associated with occurrence of involuntarymovement.
In the U.S., approval for an indication of tardive dyskinesia has been received byNeurocrine Biosciences, Inc., in April 2017.

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