FOR IMMEDIATE RELEASE

Tokyo, August 15, 2016

JT files New Drug Application for second tenofovir alafenamide (TAF)-based anti-HIV drug in Japan

Japan Tobacco Inc. (JT) (TSE: 2914) announced today that the Company filed a New Drug Application for a fixed-dose combination for the treatment of HIV-1 infection (emtricitabine and tenofovir alafenamide 200/10 mg and 200/25 mg; F/TAF) to the Japanese Ministry of Health, Labour and Welfare on 12th August.

Under the terms of the agreement on March 2015, Torii Pharmaceutical Co., Ltd. (Torii) (TSE: 4551) holds exclusive rights to market F/TAF for the treatment of HIV infection in Japan, subsequent to JT's obtaining manufacturing and marketing approval from the country's authorities.

Tenofovir disoproxil fumarate (TDF), one of two ingredients of Truvada® Combination Tablets which has been marketed by Torii in Japan since 2005, is replaced with TAF to compose F/TAF.

TAF is a novel targeted prodrug of tenofovir, a nucleotide reverse transcriptase inhibitor, discovered by Gilead Sciences, Inc. (Gilead). It has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth of that of TDF in Gilead's clinical trials in combination with other antiretroviral agents. TAF has been granted orphan drug designation for the treatment of HIV infection in Japan since November 2015.

In the United States and European Union (EU), F/TAF was approved in April 2016 and has been marketed by Gilead under the name of Descovy®. Descovy® is included in the recommended initial regimens for antiretroviral-naïve patients in "Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents" issued by U.S. Department of Health and Human Services.

  • Genvoya® Combination Tablets, Torii just launched in July 2016 in Japan, contains TAF as one of its four compounds.

  • Truvada, Descovy and Genvoya are registered trademarks of Gilead.

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Japan Tobacco Inc. is a leading international tobacco company. Its products are sold in over 120 countries and its globally recognized brands include Winston, Camel, Mevius, LD and Natural American Spirit. With diversified operations, JT is also actively present in pharmaceuticals and processed foods. The company's revenue was ¥2.253 trillion (US$18,679 million(*)) in the fiscal year ended December 31, 2015.

*Translated at the rate of ¥120.61 per $1, as of December 31, 2015

Contact for Japan Tobacco Inc.: Contact for Torii Pharmaceutical Co., Ltd.:

Ryohei Sugata, General Manager

Corporate Planning Department

Media and Investor Relations Division

(Public Relations)

Japan Tobacco Inc.

Torii Pharmaceutical Co., Ltd.

Tokyo: +81-3-5572-4292

Tokyo: +81-3-3231-6814

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

Japan Tobacco Inc. published this content on 15 August 2016 and is solely responsible for the information contained herein.
Distributed by Public, unedited and unaltered, on 15 August 2016 06:10:04 UTC.

Original documenthttps://www.jt.com/media/news/2016/pdf/20160815_E02.pdf

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