Keryx Biopharmaceuticals, Inc. has entered into a licensing agreement with Japan Tobacco Inc. and Torii Pharmaceutical Co., Ltd, JT's pharmaceutical business subsidiary, under which JT and Torii will hold the exclusive rights for the development and commercialisation 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, said Keryx in a press release.
The licensing arrangement calls for JT and Torii to pay to Keryx up to $100 million in upfront license fees and payments upon the achievement of pre-specified milestones, including up to $20 million in upfront payments and near-term milestones. In addition, upon commercialisation, 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 commercialisation 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 per cent of the dialysis population. Japan is the 2nd largest national ESRD market after the United States with approximately 250,000 patients receiving dialysis, the company said.
Keryx holds a worldwide license (except for the Asian Pacific Region, but including Japan) to Zerenex from Panion & BF Biotech, Inc. Keryx is actively engaged in the development of Zerenex for the United States and is considering additional potential sublicenses in other parts of the world. Zerenex, 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 hyperphosphatemia.
"We are pleased to have entered into this relationship with JT and Torii. 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" said, Michael S. Weiss, chairman and CEO, Keryx.
"This arrangement with JT and Torii confirms our belief that there is a significant need for a novel phosphate binder like Zerenex and we look forward to working with our new partners moving the product forward in Japan," said, Ken Hoberman, head of business development, Keryx.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development and commercialisation 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 (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.