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April 23, 2012
| Japan Tobacco Inc. |
| Torii Pharmaceutical Co., Ltd. |
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Top-line results of the JTT-751 Phase 3 clinical study in Japan
(GBA4-1) for the treatment of hyperphosphatemia |
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Tokyo, April 23, 2012 --- Japan Tobacco Inc. (JT) (TSE:2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE:4551) have announced the top-line results of GBA4-1. This study is a part of the Phase 3 program for JTT-751 (ferric citrate), conducted in Japan, for the treatment of hyperphosphatemia.
GBA4-1 was an open-label, randomized, parallel-group, active comparator study to evaluate the efficacy and safety of JTT-751 in comparison to sevelamer hydrochloride over 12 weeks among chronic kidney disease (CKD) patients with hyperphosphatemia who are on hemodialysis. In the top-line results which evaluated the change of serum phosphorus from baseline, the primary endpoint of efficacy has met non-inferiority to sevelamer hydrochloride. Furthermore, there were no clinically significant findings on safety and tolerability of JTT-751 within the treatment period.
JT will aim to submit a marketing application for JTT-751 in Japan, in the fiscal year ending March 31 2013, based on the results of GBA4-1 and other Phase 3 studies for JTT-751 which are currently being conducted.
JT and Torii hold the exclusive rights to develop and commercialize JTT-751 in Japan, which were licensed from Keryx Biopharmaceuticals, Inc. in September 2007.
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, 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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