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November 27, 2018

Launch of "P-TOL® Granules" for the Treatment of Hyperphosphatemia

Kissei Pharmaceutical Co., Ltd. (Chairman and CEO: Mutsuo Kanzawa [hereinafter referred to as "Kissei"]) announced today that "P-TOL® Granules 250 mg" and "P-TOL® Granules 500 mg," which are new dosage forms of "P-TOL® Chewable Tab." (generic name: Sucroferric oxyhydroxide), will be launched on November 28, 2018 in Japan for the treatment of hyperphosphatemia.

Kissei has received exclusive development and marketing rights for P-TOL® in Japan from Vifor Fresenius Medical Care Renal Pharma Ltd. (Head Office: Switzerland; CEO: David Bevan). Kissei developed the drug for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. P-TOL® was launched in November 2015 in the dosage form of chewable tablets. Chewable tablets offer benefits to patients on dialysis who require fluid restriction, because they can be taken without water. In contrast, elderly patients, whose number has increased in recent years, sometimes have difficulty in crushing chewable tablets owing to masticatory dysfunction. Therefore, we have developed a new dosage form, which is micro-tablet-type of P-TOL® Granules with a diameter of 2.3 mm, only for the Japan market. This dosage form enables patients to take the drug without chewing, and it does not get stuck in dentures. It was approved by the Ministry of Health, Labour and Welfare in Japan in September 2018.

P-TOL® decreases serum phosphate concentration through the binding of oxyhydroxide iron with phosphoric acid in the gastrointestinal tract and reducing in vivo phosphate absorption. As of November 2018, the drug has been approved in 41 countries and marketed in 25 countries worldwide (overseas brand name: Velphoro®).

According to data obtained at the end of year 2016, 329 thousand patients were on chronic dialysis in Japan. Kissei has focused on renal disease and dialysis field as one of the priority areas. Through the addition of P-TOL® Granules to our product lineup, we aim to further contribute to the field of dialysis treatment and offer a new therapeutic option to patients.


<Product Summary of P-TOL® Granules>
Brand Name:
P-TOL® Granules 250 mg
P-TOL® Granules 500 mg

Generic Name:
Sucroferric oxyhydroxide

Indications:
Improvement of hyperphosphatemia in patients with chronic kidney disease 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 the symptoms and serum phosphate levels. The maximum daily dose is 3000 mg.

NHI price:
P-TOL® Granules 250 mg single-dose sachet: ¥176.10
P-TOL® Granules 500 mg single-dose sachet: ¥258.70

Date of Drug Price Listing: November 28, 2018

Date of Launch in Japan: November 28, 2018

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