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Top-line results of the jtt-751 phase 3 clinical study in japan (gba4-1) for the treatment of hyperphosphatemia
FOR IMMEDIATE RELEASE
Tokyo, April 23, 2012
Top-line results of the JTT-751 Phase 3 clinical study in Japan
(GBA4-1) for the treatment of hyperphosphatemia
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
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.
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
Contact for Torii Pharmaceutical Co., Ltd.:
Ryohei Sugata, Associate General Manager
Japan Tobacco Inc. Tokyo: +81-3-5572-4292 E-mail: email@example.com
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 adjusted net sales(*) were ¥1.946 trillion (US$23,415 million(**)) in the fiscal year ended March 31, 2011. * Adjusted net sales on a consolidated basis do not include excise tax and revenue from the imported
tobacco, domestic duty free, the China Division and other peripheral businesses in the Japanese domestic tobacco business. Nor does it include excise tax and revenue from distribution, contract manufacturing and other peripheral businesses in the international tobacco business.
**Translated at the rate of ¥83.15 per $1, as of March 31, 2011
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