~ Co-promotion of Hyperkalemia Treatment ARGAMATE® and Hyperphosphatemia Treatment Bixalomer ~
Tokyo, February 20, 2012 - Astellas Pharma Inc. (“Astellas”; Tokyo:4503; President and CEO: Yoshihiko Hatanaka) and Sanwa Kagaku Kenkyusho Co., Ltd. (“SKK”; Headquarters: Nagoya; President: Kazuo Yamamoto) announced today that they agreed to establish a strategic alliance for the pharmaceutical market for kidney diseases in Japan, on February 14, 2012.
Under this agreement, Astellas will distribute and both companies will co-promote the hyperkalemia treatment ARGAMATE® 20% Jelly 25g (generic name: calcium polystyrene sulfonate, “ARGAMATE”) which SKK is currently manufacturing and distributing, with SKK supplying the product to Astellas. Also, Astellas will distribute and both companies will co-promote the hyperphosphatemia treatment bixalomer (generic name, development code: ASP1585), whose market authorization application Astellas submitted to the Ministry of Health, Labour and Welfare in Japan.
ARGAMATE is a pharmaceutical product whose administration compliance has been improved by jellification. It helps to evacuate the excessive potassium in the gastrointestinal tract by exchanging potassium ions in the intestine with the drug’s calcium ions. It is usually used to treat hyperkalaemia caused by acute or chronic renal failure.
Bixalomer is an amine-functional polymer which decreases serum phosphorus concentration by binding to phosphate in the gastrointestinal tract and thus inhibiting the absorption of phosphate into the human body. Phase III studies in patients on dialysis with chronic kidney disease in Japan demonstrated bixalomer’s clinical efficacy in the decrease of serum phosphorus concentration, as well as a preferable long-term safety profile. In March 2011, Astellas submitted a market authorization application for the indication of hyperphosphatemia in patients on dialysis with chronic kidney diseases.
Astellas and SKK expect to further contribute to patients with kidney diseases by providing various medical treatments for the pharmaceutical market for kidney diseases in Japan through this strategic alliance.
The impact of this agreement on Astellas’ financial results will be immaterial.