Print Page  Close Window

Press Release

Keryx Biopharmaceuticals, Inc. Enters into Licensing Agreement with Japan Tobacco and Torii Pharmaceutical for Development and Commercialization of Hyperphosphatemia Drug in Japan
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 population. Japan is the 2nd largest national ESRD market after the United States with approximately 250,000 patients receiving dialysis.

Keryx holds a worldwide license (except for the Asian Pacific Region, but including Japan) to Zerenex(TM) from Panion & BF Biotech, Inc. Keryx is actively engaged in the development of Zerenex(TM) for the United States and is considering additional potential sublicenses in other parts of the world. Zerenex(TM), an oral, iron-based compound that has the capacity to bind to phosphorous and form non-absorbable complexes, has the potential to be an effective and safe treatment in lowering and/or maintaining serum phosphorus levels <5.5 mg/dl="" in="" patients="" with="" esrd="" and="">

"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 have proven themselves to be ideal partners for smaller U.S.-based biotechnology companies seeking development and commercial partners in Japan. We are excited that they have chosen our phosphate binder for commercialization in Japan. We are committed to bringing forward globally this novel product and we are confident that by working together with JT and Torii we will be successful in bringing this valuable treatment option to patients in Japan."

"This arrangement with JT and Torii confirms our belief that there is a significant need for a novel phosphate binder like Zerenex(TM) and we look forward 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, development and commercialization of medically important, novel pharmaceutical products for 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 compound for the treatment of diabetic nephropathy, a life-threatening kidney disease caused by diabetes. Sulonex is in a pivotal Phase 3 and Phase 4 clinical program under a Special Protocol Assessment with the Food & Drug Administration. Additionally, Keryx is developing Zerenex(TM), an oral, iron- based compound that has the capacity to bind phosphate and form non-absorbable complexes. Zerenex is currently in Phase 2 clinical development for the treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients with end- stage renal disease. Keryx is also developing clinical-stage oncology compounds, including KRX-0401 (perifosine), a novel, first-in-class, oral modulator of Akt, a pathway associated with tumor survival and growth, and other important signal transduction pathways. KRX- 0401 is currently in Phase 2 clinical development for multiple tumor types. Keryx also has an active in-licensing and acquisition program designed to identify and acquire additional drug candidates. Keryx is headquartered in New York City.

About Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd.

Japan Tobacco Inc. is the world's third largest international manufacturer of tobacco products. Since its privatization in 1985, JT has actively diversified its operations into pharmaceuticals and foods. JT entered into the pharmaceutical business in 1987 and established the Central Pharmaceutical Research Institute in 1993. JT is currently engaged in the research and development of new drugs in various areas such as glucose and lipid metabolism, anti-virus, immune disorders and inflammation, and bone metabolism. The company's net sales were 4.769 trillion yen in the fiscal year that ended March 31, 2007.

Torii Pharmaceutical Co., Ltd., established in 1921, has manufactured and distributed ethical pharmaceutical products. In 1998, Torii became a member of the JT Group. To maximally leverage the synergy of the Group, R&D functions were transferred to JT and sales and marketing functions were transferred to Torii. Torii and JT continue to operate in close collaboration. Torii's net sales were approximately 39,577 million yen in the fiscal year that ended March 31, 2007.

KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965