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    2914   JP3726800000

JAPAN TOBACCO INC.

(2914)
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Japan Tobacco : Listing on the Japanese National Health Insurance Drug Price List and Launch of CORECTIM Ointment 0.25% in Japan

05/26/2021 | 02:05am EDT

FOR IMMEDIATE RELEASE

Tokyo, May 26, 2021

Listing on the Japanese National Health Insurance Drug Price List and

Launch of CORECTIM® Ointment 0.25% in Japan

Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced that CORECTIM® Ointment 0.25% (generic name: delgocitinib), a Janus kinase (JAK) inhibitor, has been listed on the Japanese National Health Insurance (NHI) drug price list as of today. Torii plans to launch CORECTIM® Ointment 0.25% in Japan on June 21, 2021.

CORECTIM® Ointment 0.25% is a non-steroidal, JAK inhibitor that is expected to improve autoimmune and allergic diseases by inhibiting the action of JAKs, which play key roles in immune activation signalling in cells, by suppressing the overactivation of immune responses. In the Phase 3 comparative clinical study of CORECTIM® Ointment 0.25% in pediatric patients with atopic dermatitis (aged 2 to <16) conducted in Japan, the primary endpoint of efficacy, the percentage change of the mEASI score* from baseline, has met superiority to the placebo. Safety of long-term administration of CORECTIM® Ointment 0.25% was also confirmed.

JT and Torii expect CORECTIM® Ointment 0.25% to be a new option for the treatment of pediatric patients with atopic dermatitis in Japan. CORECTIM® Ointment 0.5%, the world's first topical JAK inhibitor as an indication of atopic dermatitis in adults, has been distributed in Japan by Torii since June 2020. JT has received manufacturing and marketing approval for CORECTIM® Ointment 0.25% for an indication of pediatric atopic dermatitis as well as approval for additional pediatric dosage and administration for CORECTIM® Ointment 0.5% in Japan on March 23, 2021.

Separately, the Phase 3 clinical study in infant patients with atopic dermatitis (aged 6 to <24 months) for delgocitinib is being conducted in Japan.

  • mEASI score (modified) is the score except for head and neck part from Eczema Area and Severity Index (EASI) score, a tool used to measure the extent area and severity of atopic dermatitis.

ABOUT CORECTIM® Ointment 0.25%

Product Name:

CORECTIM® Ointment 0.25%

Generic Name:

Delgocitinib

Indications:

Atopic Dermatitis

Dosage and

For children, apply an appropriate amount of 0.25%

Administration:

formulation to the affected areas twice daily. 0.5%

formulation can be applied twice daily depending on the

symptoms. The dose applied should not exceed 5 g per

dosing, however, the body size should be taken into

consideration.

Package:

Tubes : 5g × 10

NHI Drug Price:

¥141.40 (0.25% 1g

Approval Date:

March 23, 2021

NHI Pricing Date:

May 26, 2021

Launch Date:

June 21, 2021

Manufacturing and

Japan Tobacco Inc.

Distributor:

Distributor:

Torii Pharmaceutical Co., Ltd.

ABOUT Atopic Dermatitis

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

###

Japan Tobacco Inc. is a leading international tobacco company with operations in more than 130 countries. With approximately 58,000 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 the 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: +81-3-6636-2026

Torii Pharmaceutical Co., Ltd. Tokyo: +81-3-3231-6814

E-mail: jt.media.relations@jt.com

E-mail: webmaster@torii.co.jp

Disclaimer

Japan Tobacco Inc. published this content on 26 May 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 May 2021 06:04:07 UTC.


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