Press release

Kissei receives Japanese approval for P-TOL® (in the USA and Europe commercialized as Velphoro®)

Wednesday, 30 September 2015, ↓ directly to download

Sucroferric oxyhydroxide receives approval by the Ministry of Health, Labour and Welfare in Japan for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis under the name “P-TOL®” (in the USA and Europe commercialized as Velphoro®)

Kissei Pharmaceutical Co., Ltd. announced that a new drug application for “P-TOL® Chewable Tablets 250mg” and “P-TOL® Chewable Tablets 500mg” (sucroferric oxyhydroxide) for treatment of hyperphosphatemia has been approved by the Ministry of Health, Labour and Welfare in Japan.

P-TOL®/Velphoro® (previously known as PA21) is an iron-based, non-calcium-based, chewable phosphate binder. It 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.

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Galenica is a diversified Group active throughout the healthcare market which, among other activities, develops, manufactures and markets pharmaceutical products, runs pharmacies, provides logistical and database services and sets up networks. With its two Business units Vifor Pharma and Galenica Santé, the Galenica Group enjoys a leading position in all its core business activities. A large part of the Group’s income is generated by international operations. Galenica is listed on the Swiss Stock Exchange (SIX Swiss Exchange, GALN, security number 1,553,646).

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Christina Hertig

Christina Hertig

Head of Corporate Communications


Galenica Ltd.

Corp. Communications
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CH-3027 Bern

Phone:
+41 58 852 85 17
Fax:
+41 58 852 85 58

Julien Vignot

Julien Vignot

Head Investor Relations


Galenica Ltd.

Investor Relations
Untermattweg 8
CH-3027 Bern

Phone:
+41 58 852 81 11
Fax:
+41 58 852 81 12

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