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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

Friday, October 5, 2007 General News
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NEW YORK, Sept. 26 Keryx Biopharmaceuticals,Inc. (Nasdaq: KERX), announced today that it entered into a licensingagreement with Japan Tobacco Inc. (JT) (TSE: 2914) and Torii PharmaceuticalCo., Ltd. (Torii) (TSE: 4551), JT's pharmaceutical business subsidiary, underwhich JT and Torii will hold the exclusive rights for the development andcommercialization of its hyperphosphatemia drug in Japan. The drug, an iron-based phosphate binder for the treatment of hyperphosphatemia (elevatedphosphate levels) in patients with end stage renal disease, is currently inphase II clinical development in the United States under the name of"Zerenex(TM)." The licensing arrangement calls for JT and Torii to pay toKeryx up to $100 million in up-front license fees and payments upon theachievement 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 inJapan. JT and Torii will be responsible for the future development andcommercialization costs in Japan.
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Phosphate retention and the resulting hyperphosphatemia in patients withESRD on dialysis are usually associated with secondary hyperparathyroidism,renal osteodystrophy, soft tissue mineralization and the progression of renalfailure. ESRD patients usually require treatment with phosphate-binding agentsto lower and maintain serum phosphorus at acceptable levels. There are over300,000 dialysis patients in the United States, and even with current therapy,hyperphosphatemia persists in 70% of the dialysis population. Japan is the2nd largest national ESRD market after the United States with approximately250,000 patients receiving dialysis.
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Keryx holds a worldwide license (except for the Asian Pacific Region, butincluding Japan) to Zerenex(TM) from Panion & BF Biotech, Inc. Keryx isactively engaged in the development of Zerenex(TM) for the United States andis considering additional potential sublicenses in other parts of the world.Zerenex(TM), an oral, iron-based compound that has the capacity to bind tophosphorous and form non-absorbable complexes, has the potential to be aneffective and safe treatment in lowering and/or maintaining serum phosphoruslevels <5.5 mg/dL in patients with ESRD and hyperphosphatemia.

"We are pleased to have entered into this relationship with JT and Torii,"stated Michael S. Weiss, Chairman and CEO of Keryx, who continued, "They haveproven themselves to be ideal partners for smaller U.S.-based biotechnologycompanies seeking development and commercial partners in Japan. We areexcited that they have chosen our phosphate binder for commercialization inJapan. We are committed to bringing forward globally this novel product andwe are confident that by working together with JT and Torii we will besuccessful in bringing this valuable treatment option to patients in Japan."

"This arrangement with JT and Torii confirms our belief that there is asignificant need for a novel phosphate binder like Zerenex(TM) and we lookforward to working with our new partners moving the product forward in Japan,"stated Ken Hoberman, head of Business Development for Keryx.

About Keryx Biopharmaceuticals, Inc.

Keryx Biopharmaceuticals, Inc. is focused on the acquisition, developmentand commercialization of medically important, novel pharmaceutical productsfor the treatment of life-threatening diseases, including diabetes and cancer.Keryx's lead compound under development is Sulonex(TM) (sulodexide),previously referred to as KRX-101, a first-in-class, oral heparinoid compoundfor the treatment of diabetic nephropathy, a life-threatening kidney diseasecaused by diabetes. Sulonex is in a pivotal Phase 3 and Phase 4 clinicalprogram under a Special Protocol Assessment with the Food & DrugAdministration. Additionally, Keryx is developing Zerenex(
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