November 19, 2014

New Drug Application Submitted for "PA21 (development code)" for Treatment of Hyperphosphatemia

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 "PA21 (development code, hereinafter referred to as the "Agent") " for treatment of hyperphosphatemia has been filed with the Ministry of Health, Labour and Welfare in Japan.

Kissei has developed the Agent after acquisition of exclusive development and marketing rights to the Agent in Japan in September 2010. Vifor Fresenius Medical Care Renal Pharma Ltd. (Head Office: Switzerland; CEO: Stefan Schulze) is a licensing company of the Agent which has been approved in 32 countries worldwide and is currently marketed under the brand name Velphoro® in the U.S.,Germany and Portugal.

The Agent is an iron-based phosphate binder for treatment of hyperphosphatemia which decreases serum phosphate concentration by binding to phosphoric acid in the gastrointestinal tract and reducing in vivo phosphate absorption. In addition, it is expected to provide dialysis patients who require fluid restriction with a new treatment option because it can be taken orally without water.

The number of chronic dialysis patients is growing every year and has reached about 0.31 million in Japan as of the end of 2013. We aim to further contribute to dialysis treatment through enhancement of our product lineup in the dialysis field by obtaining marketing authorization of the Agent.

-About Vifor Fresenius Medical Care Renal Pharma Ltd.-
A common company of Galenica and Fresenius Medical Care develops and commercialises innovative and high quality therapies to improve the life of patients suffering from Chronic Kidney Disease (CKD) worldwide. The company was founded at the end of 2010 and is owned 55% by Galenica and 45% by Fresenius Medical Care.

-About hyperphosphatemia-
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 control of phosphate intake by dietary therapy and removal of phosphate by dialysis, current treatment for chronic dialysis patients with hyperphosphatemia includes various phosphate binders to reduce phosphate absorption from the gastrointestinal tract.