New Drug Application Approval for "P-TOL®Chewable Tablets" for the Treatment of Hyperphosphatemia in Japan

Kissei Pharmaceutical Co., Ltd.

Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa (hereinafter referred to as "Kissei")] announced today that a new drug application for "P-TOL^® Chewable Tablets 250mg" and "P-TOL^® Chewable Tablets 500mg" (development code: PA21, generic name: sucroferric oxyhydroxide, hereinafter referred to as the "Agent") for treatment of hyperphosphatemia has been approved by the Ministry of Health, Labour and Welfare in Japan.

Kissei developed the Agent in Japan with the aim of improving hyperphosphatemia in chronic kidney disease patients on dialysis and submitted new drug application for the Agent in November 2014; the application was approved today.

Chronic dialysis patients experience hyperphosphatemia due to an increase in serum phosphate levels. This increase is caused by excess absorption of phosphate from the diet, which cannot be excreted by the kidneys because of renal impairment. Appropriate control of serum phosphate levels is required in patients with hyperphosphatemia because hyperphosphatemia is one of the precipitating factors of vascular calcification and is related to cardiovascular disorders such as cardiac failure, which increases the mortality risk. In addition to restriction of dietary phosphate intake by dietary therapy and removal of phosphate by dialysis, current treatment for hyperphosphatemia in patients with chronic dialysis patients includes various phosphate binders to reduce phosphate absorption from the gastrointestinal tract.

The Agent decreases serum phosphate concentration by binding to phosphoric acid in the gastrointestinal tract and reducing in vivo phosphate absorption. The lowering effects of serum phosphorus concentration and safety at long-term administration of the Agent were confirmed in a phase Ⅲ clinical study in Japan intended for chronic renal failure patients on hemodialysis with hyperphosphatemia.

Kissei has focused on the kidney and dialysis fields as one of the priority areas. We aim to further contribute to the field of dialysis treatment by enhancing our product lineup in this field by launching the Agent in Japan.



〈P-TOL^® reference〉

Brand Name:
P-TOL^® Chewable Tablets 250 mg
P-TOL^® Chewable Tablets 500 mg

Generic Name:
Sucroferric oxyhydroxide

Indications:
Improvement of hyperphosphatemia in chronic kidney disease patients on dialysis

Dosage and Usage:
Usually, for adults, the starting dose is 250 mg of iron administered orally three times daily immediately before meals. Thereafter, the dose should be adjusted as necessary according to symptoms and the degree of serum phosphorus levels. The maximum daily dose is 3000 mg.

Manufactured and Distributed by:
KISSEI PHARMACEUTICAL CO., LTD.