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Keryx Biopharmaceuticals, Inc. Enters into Licensing Agreement with Japan Tobacco and Torii Pharmaceutical for Development and Commercialization of Hyperphosphatemia Drug in Japan
Date:9/26/2007

Deal Includes up to $100MM in License Fees and Potential Milestone Payments

NEW YORK, Sept. 26 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX), announced today that it entered into a licensing agreement with Japan Tobacco Inc. (JT) (TSE: 2914) and Torii Pharmaceutical Co., Ltd. (Torii) (TSE: 4551), JT's pharmaceutical business subsidiary, under which JT and Torii will hold the exclusive rights for the development and commercialization of its hyperphosphatemia drug in Japan. The drug, an iron- based phosphate binder for the treatment of hyperphosphatemia (elevated phosphate levels) in patients with end stage renal disease, is currently in phase II clinical development in the United States under the name of "Zerenex(TM)." The licensing arrangement calls for JT and Torii to pay to Keryx up to $100 million in up-front license fees and payments upon the achievement of pre-specified milestones, including up to $20 million in up- front payments and near-term milestones. In addition, upon commercialization, JT and Torii will make royalty payments to Keryx on net sales of the drug in Japan. JT and Torii will be responsible for the future development and commercialization costs in Japan.

Phosphate retention and the resulting hyperphosphatemia in patients with ESRD on dialysis are usually associated with secondary hyperparathyroidism, renal osteodystrophy, soft tissue mineralization and the progression of renal failure. ESRD patients usually require treatment with phosphate-binding agents to lower and maintain serum phosphorus at acceptable levels. There are over 300,000 dialysis patients in the United States, and even with current therapy, hyperphosphatemia persists in 70% of the dialysis popula
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SOURCE Keryx Biopharmaceuticals, Inc.
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