September 17, 2010
License Agreement of "iron-oxyhydroxide" for the treatment of hyperphosphatemia in dialysis patients
Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; President and CEO: Mutsuo Kanzawa ("Kissei")] announced today that Kissei has entered into a license agreement with Vifor Pharma. [Head Office: Zurich, Switzerland; CEO: David Ebsworth. ("Vifor Pharma")] to obtain the exclusive right in Japan for development and commercialization of "iron-oxyhydroxide" (the "Agent") which is being developed by Vifor Pharma for the treatment of hyperphosphatemia in dialysis patients.
As kidney function is impaired in dialysis patients, excess phosphate absorbed from the diet is not sufficiently excreted from the body by the kidney. Consequently, serum phosphate levels increase and hyperphosphatemia is likely to occur. Hyperphosphatemia has a high potential to induce vascular calcification, leading to arterial sclerosis as well as bone deformation, pain and fracture. Therefore, adequate control of phosphate levels is required.
In addition to dietary restriction therapy, current treatment for hyperphosphatemia includes a variety of phosphate binders to reduce phosphate absorption from the GI tract. The Agent is a novel phosphate binder based on iron (iron-oxyhydroxide) that may provide a new treatment option for dialysis patients with hyperphosphatemia. The Agent can be taken orally without additional water.
The efficacy and safety has been demonstrated in a phase II clinical study in the US and Europe conducted by Vifor Pharma. Preparations for initiating a phase III clinical study by Vifor Pharma are underway.
The number of dialysis patients is growing every year and 290,000 of dialysis patients are estimated to live in Japan as of end of 2009.Kissei sells and markets Fragmin for prevention of clotting in the extracorporeal system during hemodialysis and Fulstan of active vitamin D3 in dialysis field. In addition, in this May Kissei has launched Epoetin alfa BS injection [JCR] which is the first product in Japan as a follow-on biologics for erythropoietin. Kissei will have more reinforced and enhanced R&D line-up of dialysis area by the introduction of this Agent.
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Vifor Pharma:
Vifor Pharma is the Pharma business sector of the Galenica group who is one of listed companies in Switzerland. Sales amount of Vifor in 2009 was approximately 40 billion yen and total number of employees is about 1,300. Vifor Pharma researches, develops, manufactures andmarkets pharmaceutical products and OTC products. In addition, Vifor Pharma is one of leading companies in the field of treatment ofiron deficiency. Their main products are agents in the field of anemia, renal disease and autoimmune disease.
Iron -oxyhydroxide:
It is a novel phosphate binder (Code: PA21) under development by Vifor Pharma. The Agent promotes the excretion of phosphate by binding to excess phosphate in the diet and is used by dialysis patients mainly. The efficacy and safety of the Agent in hemodialysis patients has been demonstrated in a completed phase II clinical study in the US/Europe. Preparations for initiating a phase III clinical study by Vifor Pharma are underway.