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Press Release

April 25, 2013

Japan Tobacco Inc.
Torii Pharmaceutical Co., Ltd.
Launch of a novel anti-HIV drug “Stribild® Combination Tablets” in Japan
Tokyo, April 25, 2013 --- Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co. Ltd. (Torii) (TSE:4551), JT’s pharmaceutical subsidiary, announced today that Torii would launch a novel anti-HIV drug, “Stribild® Combination Tablets” in Japan on May 14, 2013.  JT received manufacturing and marketing approval for this drug from the Japanese Ministry of Health, Labour and Welfare on March 25, 2013.

“Stribild® Combination Tablets” contains four compounds in a single tablet regimen: elvitegravir 150 mg; cobicistat 150 mg; emtricitabine 200 mg; and tenofovir disoproxil fumarate 300 mg.

Combination antiretroviral therapy has been a standard of care for HIV infection. Adherence is a key to increase potential for the treatment’s success with reducing the emergence of a drug-resistant virus. Accordingly, a drug which is easier and convenient to use, such as a single tablet regimen, has been desired by physicians and their patients.

“Stribild® Combination Tablets” is the first complete, once-daily, single tablet regimen to be commercialized in Japan which is used without other drugs for the treatment of HIV. The drug is expected to provide convenience and long-term adherence for patients.

Currently in the JT Group, Torii has been marketing anti-HIV drugs in Japan including “Truvada® Combination Tablets”, “Emtriva® Capsules 200mg”, “Viread® Tablets 300mg” and “Viracept® Tablets 250mg”. Marketing of “Stribild® Combination Tablets” in Japan would constitute another contribution by JT Group to the treatment of HIV.

The effects on business performance of this launch are included in both the Group’s consolidated and Torii’s forecasts for the fiscal year ending March 31, 2014, announced on April 25, 2013.

About Stribild® Combination Tablets

Product Name: Stribild® Combination Tablets
Generic Name: elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil fumarate
Indications: HIV-1 Infection

Dosage and Administration:

  The usual adult dosage for oral use is one tablet (containing 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 300 mg of tenofovir disoproxil fumarate) once daily with or immediately after a meal.
Packages: Stribild® Combination Tablets: (Bottle) 30 tablets
NHI Drug Price: ¥ 6,749.30 per tablet
Approval Date: March 25, 2013
NHI Pricing Date: April 16, 2013
Launch Date: May 14, 2013

Manufacturer and Distributor: Japan Tobacco Inc.

Distributor: Torii Pharmaceutical Co., Ltd.

“Stribild® Combination Tablets” contains four compounds in a complete, once-daily, single tablet regimen: elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate. Outside Japan, the drug has been developed and commercialized by Gilead Sciences, Inc. (Gilead). The drug has been provided to HIV patients in the United States.

Elvitegravir, a novel HIV integrase inhibitor, is JT’s original compound, and interferes with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells. The Company licensed elvitegravir to Gilead in March 2005 with exclusive rights to develop and commercialize the drug worldwide, excluding Japan.

Cobicistat is Gilead’s pharmacoenhancing or “boosting” agent that maintains blood levels of elvitegravir by inhibiting the cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body.

Emtricitabine and tenofovir disoproxil fumarate, nucleoside reverse transcriptase inhibitors, have been marketed as “Emtriva® Capsules 200mg” and “Viread® Tablets 300mg” respectively in Japan. In addition, a co-formulation of these drugs has been marketed as “Truvada® Combination Tablets” in the country. These drugs have been sold exclusively by Torii.

* Elvitegravir and cobicistat as standalone agents are investigational products and their safety and efficacy have not yet been established worldwide, including in Japan.

* Stribild, Emtriva, Viread and Truvada are registered trademarks of Gilead Sciences, Inc.


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