Announcement of the Launch of "P-TOL® Chewable Tab." 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 ("Kissei")] announced the launch of "P-TOL^® Chewable Tab. 250mg" and "P-TOL^® Chewable Tab. 500mg" (generic name: sucroferric oxyhydroxide) for treatment of hyperphosphatemia (National Health Insurance price entry November 26, 2015) on November 27, 2015.

Kissei has developed P-TOL^® after acquisition of exclusive development and marketing rights in Japan in September 2010. Vifor Fresenius Medical Care Renal Pharma Ltd. (Head Office: Switzerland; CEO: Stefan Schulze) is a licensing company, and P-TOL^® has been approved in 35 countries worldwide and is currently marketed under the brand name Velphoro^® in the U.S., Europe, and some other countries.

P-TOL^® 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 P-TOL^® were confirmed in a phase Ⅲ clinical study in Japan intended for chronic renal failure patients on hemodialysis with hyperphosphatemia.

The number of chronic dialysis patients is growing every year and has reached about 0.32 million in Japan as of the end of 2014. We focus and position the kidney-dialysis area in one of the priority areas. We aim to further contribute to dialysis treatment through enhancement of our product lineup in the dialysis field by launching of P-TOL^®.



〈P-TOL^® Product 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 Administration:
The usual starting dose for adults 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 serum phosphorus levels. The maximum daily dose is 3000 mg.

Characteristics:
1. Containing iron (III), a physiological metal, it is a phosphorus adsorption drug with a complex structure.
2. It has shown excellent serum phosphorus concentration lowering effect.
3. Over a period of 52 weeks, the serum phosphorus concentration was maintained within the range of the management target value (3.5-6.0 mg/dL).*
* management target value of clinical practice guidelines of bone and mineral metabolism abnormalities associated with chronic kidney disease (CKD-MBD)
4. A donut-shaped disintegrating chewable tablet
5. Side effects were observed in 159 cases of 494 cases (32.2%) (at the time of approval). The main side effect was diarrhea (22.7%).

NHI price:
P-TOL^® Chewable Tablets 250 mg one tablet ¥214.20
P-TOL^® Chewable Tablets 500 mg one tablet ¥314.30

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