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January 7, 2013

Japan Tobacco Inc.
Torii Pharmaceutical Co., Ltd.
New Drug Application for marketing approval of JTT-751 (ferric citrate) for the
treatment of hyperphosphatemia filed by JT in Japan
Tokyo, January 7, 2013 ---  Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) announced today that JT has filed a New Drug Application (NDA) for marketing approval of JTT-751 (ferric citrate) for the treatment of hyperphosphatemia with the Japanese Ministry of Health, Labour and Welfare. JT and Torii hold the exclusive rights to develop and commercialize JTT-751 in Japan, which were licensed in September 2007 from Keryx Biopharmaceuticals, Inc. Since then, JT and Torii have jointly conducted the development of the drug.

With ferric citrate as the active component, JTT-751 is a novel phosphate binder which decreases serum phosphorus concentration through inhibiting phosphate absorption into the body by binding iron and phosphate in the gastrointestinal tract. Clinical efficacy in the decrease of serum phosphorus concentration was proven in Phase 3 studies in chronic kidney disease (CKD) patients with hyperphosphatemia in Japan. Furthermore, no clinically significant findings on safety and tolerability of JTT-751 were observed in clinical studies. JT and Torii expect JTT-751 to become a new therapeutic option for the treatment of hyperphosphatemia.

Following Japanese NDA approval, this drug will be sold exclusively by Torii in Japan.



About Hyperphosphatemia

Patients with CKD often suffer from hyperphosphatemia, as a result of lower phosphorous excretion from the kidney. Persisting hyperphosphatemia leads to calcareous deposition in various organs, including the blood vessels, conjunctiva, heart, lung and kidney as well as periarticular tissues. In particular, a calcified blood vessel wall causes arterial sclerosis and increases the risk of cardiac infarct and angina. Furthermore, bone lesions can be caused by secondary hyperparathyroidism associated with the increase in secretion of parathyroid hormone, negatively affecting activities of daily living and quality of life.
   
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