Shire says that marketing partner Bayer Yakuhin has launched its severe kidney disease drug Fosrenol in Japan.

The company noted that Fosrenol (lanthanum carbonate) is the first non-calcium, non-resin phosphate binder to be made commercially available in Japan. The drug is used in the control of hyperphosphataemia in chronic renal failure patients on dialysis.

Bayer Yakuhin, based in Osaka, received an exclusive licence from Shire in December 2003 to develop the drug in Japan. The Bayer subsidiary completed Phase II and III clinical trials in the Japanese population on which approval was based.

Shire says that studies based on “widespread screening programmes” in Japan indicate the country has “an extremely high prevalence of chronic kidney disease”. Some 20% of the 103.2 million adult population are living with some form of the condition and the number of dialysis patients in Japan is around 270,000. That figure is increasing by 10,000 per year.

Shirley Wakelin, the Shire manager in charge of the Fosrenol brand, added that “there is a clear medical need in Japan for an effective phosphate binder that provides sustained phosphate control and does not directly contribute to calcium load". The drug is now available in 33 markets and further launches are planned throughout 2009.

The Japanese launch of Fosrenol, which contributed $33.2 million to Shire’s fourth-quarter revenues, comes just after the company opened an office in Japan which will serve as the base for “the future commercialisation of its pipeline products in the second largest biopharmaceutical market in the world”.