Media
Top-line Results of Bioequivalence Study between JTE-052 Lotion and Ointment, JAK Inhibitor, in 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 bioequivalence study between JTE-052 (generic name: delgocitinib) , a Janus kinase (JAK) inhibitor, lotion and ointment in patients with atopic dermatitis in Japan. Delgocitinib topical formulation has been developed in Japan for patients with atopic dermatitis by JT and Torii under the terms of an agreement for co-development and marketing in Japan, signed in October 2016.
This study is to verify the bioequivalence of delgocitinib lotion 0.5% and delgocitinib ointment 0.5% based on clinical evaluations under an open-label, randomized, parallel-group, comparison design in patients with atopic dermatitis, conducted in Japan. The top-line results show the effects in improving skin eczema and bioequivalence of both delgocitinib lotion 0.5% and delgocitinib ointment 0.5%. The safety within the treatment period was also confirmed. Based on these results and other items, JT and Torii will aim to submit a manufacturing and marketing application for delgocitinib lotion 0.5% in Japan.
Torii also distributes delgocitinib ointment under the brand name CORECTIM® in Japan, where CORECTIM® Ointment 0.5% and CORECTIM® Ointment 0.25% are approved for the treatment of atopic dermatitis.
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).
###
Japan Tobacco Inc. (JT) is a global company headquartered in Tokyo, Japan. It is listed on the primary section of the Tokyo Stock Exchange (ticker: 2914.T). JT Group has approximately 53,000 employees and 62 factories worldwide, operating in three business segments: tobacco, pharmaceutical, and processed food. Within the tobacco business, the largest segment, products are sold in over 130 markets and its flagship brands include Winston, Camel, MEVIUS, and LD. The Group is committed to investing in Reduced-Risk Products and markets its heated tobacco products under its Ploom brand.
Consumers, shareholders, employees, and society are the four stakeholder groups (4S) at the heart of all of JT Group's activities. Inspired by its “Fulfilling Moment, Enriching Life” purpose, the Group aims to ensure sustainable and valuable contributions to its stakeholders over the long term. In addition to our three business segments, this goal is also supported by D-LAB, the JT Group’s corporate R&D initiative, set up to search and create added-value business opportunities. For more information, visit https://www.jt.com/.
Contact for Japan Tobacco Inc.: | Contact for Torii Pharmaceutical Co., Ltd.: |
Yunosuke Miyata, Director | Corporate Planning Department |
Investor and Media Relations Division | (Investor/Public Relations) |
Japan Tobacco Inc. Tokyo: +81-3-6636-2914 | Torii Pharmaceutical Co., Ltd. Tokyo: +81-3-3231-6814 |
E-mail: jt.media.relations@jt.com | E-mail: ir.media@torii.co.jp |