Torii Pharmaceutical : Top-line Results of Phase 3 Clinical Study (Comparative Study) of JTE-061 (tapinarof) Cream, Aryl hydrocarbon Receptor (AhR) agonist, in Adult and Adolescent Patients with Atopic Dermatitis in Japan（PDF）

FOR IMMEDIATE RELEASE

Tokyo, July 20, 2022

Top-line Results of Phase 3 Clinical Study (Comparative Study) of

JTE-061 (tapinarof) Cream, Aryl hydrocarbon Receptor (AhR)

agonist, in Adult and Adolescent Patients with Atopic Dermatitis in

Japan

Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced today the top-line results of a Phase 3 comparative study for JTE-061, conducted in Japan, for the treatment of atopic dermatitis.

JT signed an exclusive license agreement with Dermavant Sciences GmbH (Dermavant) for the development and commercialization of tapinarof, a topical, therapeutic aryl hydrocarbon receptor agonist (JTE-061), for dermatological diseases and conditions in Japan. JT also signed an exclusive license agreement with Torii for co-development and commercialization of JTE-061 in Japan. JTE-061 is being developed for patients with atopic dermatitis and plaque psoriasis.

This study is a double blind, randomized and parallel-group comparison study to evaluate the efficacy and safety of JTE-061 cream in comparison to vehicle over 8 weeks in adult and adolescent patients with atopic dermatitis. The top-line results show that the IGA response1 at week 8, the primary endpoint of efficacy, has met statistical superiority to vehicle. In addition, JTE-061 cream demonstrated higher EASI75 achievement rate2 at Week 8, key secondary endpoint of efficacy, compared with vehicle. The safety of JTE-061 cream was confirmed and there were no observed issues of tolerability for the cream.

JT and Torii will aim to submit a manufacturing and marketing application for JTE-061 cream in Japan, based on the results of the study and other Phase 3 studies currently being conducted.

Separately, Phase 3 clinical studies in patients with plaque psoriasis and Phase 2 clinical studies in pediatric patients (aged 2 to ≤11 years) with atopic dermatitis are ongoing and being conducted in Japan. Tapinarof cream developed by Dermavant has been approved for the

1. Proportion of subjects which achieve an Investigator's Global Assessment (IGA) score of 0 (Clear) or 1 (Almost clear) with a minimum of 2-grade improvement from baseline. IGA score is a tool used to measure the extent area and severity of atopic dermatitis (IGA=0: Clear, 1: Almost clear, 2: Mild, 3: Moderate, 4: Severe).
2. Proportion of subjects with a minimum of 75% improvement in Eczema Area and Severity Index (EASI) score from baseline. EASI score is a tool used to measure the extent area and severity of atopic dermatitis.

treatment of plaque psoriasis on May 23, 2022 in the U.S.

ABOUT Atopic Dermatitis

Atopic dermatitis is a chronic and pruritic inflammatory skin disease. It is thought to develop through exposure to various irritation or allergens for patients with a physiological abnormality of the skin (dry skin and abnormal skin barrier function).

ABOUT Plaque Psoriasis

Plaque Psoriasis is a chronic, systemic, inflammatory skin disease characterized by red patches and plaques with silvery scales on the skin.

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Japan Tobacco Inc. is a leading international tobacco company selling its products in more than 130 countries and regions. With approximately 55,000 employees, it manufactures and sells some of the world's best-known brands including Winston, Camel, MEVIUS and LD. The JT Group is committed to investing in Reduced-Risk Products (RRP) and currently markets its heated tobacco products under its Ploom brand and various e-cigarette products under its Logic brand. The Group is also present in the pharmaceutical and processed food businesses. For more information, visit https://www.jt.com/.

Contact for Japan Tobacco Inc.:	Contact for Torii Pharmaceutical Co., Ltd.:
Dinesh Babu Thotakura, General Manager	Corporate Planning Department
Media and Investor Relations Division	(Public Relations)
Japan Tobacco Inc. Tokyo: [phone]	Torii Pharmaceutical Co., Ltd. Tokyo: [phone]
E-mail:[e-mail]	E-mail:[e-mail]