Japan Tobacco: Single-tablet Regimen Containing JTK-303 (elvitegravir) Received U.S. Regulatory Approval

Source from:  4-traders.com 08/28/2012

Single-tablet regimen containing JTK-303 (elvitegravir) received U.S. regulatory approval, JT's partner Gilead Sciences announced. A New Drug Application (NDA) submitted on November 27, 2011, for an anti-HIV single-tablet regimen containing a novel HIV integrase inhibitor, JT's original compound JTK-303 (elvitegravir), has been approved by the U.S. Food and Drug Administration (FDA). The drug is to be marketed as Stribild? (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) in the United States. Japan Tobacco Inc. (JT) (TSE:2914) announced that a statement has been issued to this effect by Gilead Sciences, Inc. (Gilead) of Foster City, California. JT licensed its anti-HIV compound JTK-303 (elvitegravir) to Gilead in March, 2005 with the rights to develop and commercialise the drug worldwide, excluding Japan. JT will aim to submit a marketing application for the single-tablet regimen in Japan, in the fiscal year ending March 31 2013. About the fixed-dose, single-tablet The fixed-dose, single-tablet regimen contains JTK-303 (elvitegravir), the active ingredients of both Emtriva? 200mg capsule and Viread? 300mg tablet, and "cobicistat", an investigational pharmacoenhancing or "boosting" agent that increases blood levels of medicines. JTK-303 (elvitegravir) and "cobicistat" as standalone agents are investigational products and their safety and efficacy have not yet been established worldwide, including Japan. Stribild, Emtriva and Viread are trademarks or registered trademarks of Gilead Sciences, Inc. ### Japan Tobacco Inc. is a leading international tobacco product company. Its products are sold in over 120 countries and its internationally recognized cigarette brands include Winston, Camel, Mild Seven and Benson & Hedges. With diversified operations, JT is also actively present in pharmaceuticals and foods. The company's revenue were ￥2.034 trillion (US$24,745 million(*)) in the fiscal year ended March 31, 2012. *Translated at the rate of ￥82.19 per $1, as of March 31, 2012 Enditem