Kissei files for Japanese approval of PA21 for hyperphosphatemia

Japanese mid-sized drugmaker Kissei Pharmaceutical(TYO: 4547) says that a new drug application for PA21 (development code) for treatment of hyperphosphatemia has been filed with the Ministry of Health, Labor and Welfare in Japan.

Kissei has developed the agent after acquisition of exclusive development and marketing rights in Japan in September 2010 from Vifor Fresenius Medical Care Renal Pharma. The product, which has been approved in 32 countries worldwide, is currently marketed under the brand name Velphoro (sucroferric oxyhydroxide) in the USA, Germany and Portugal.

PA21 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. Kissei aims to further contribute to dialysis treatment through enhancement of its product line-up in the dialysis field by obtaining marketing authorization for the agent.

Vifor Fresenius Medical Care Renal Pharma is a joint venture between Galenica (55%), the parent of Vifor Pharma, and Fresenius Medical Care (45%), which develops and commercializes innovative and high quality therapies to improve the life of patients suffering from chronic kidney disease (CKD) worldwide.