KAKEN PHARMACEUTICAL CO., Ltd. ( head office: Bunkyo-ku, Tokyo ) has submitted application to the Japanese MHW for Fiblast ( generic name, trafermin: code No. KCB-1 ), a drug for intractable skin ulcers developed using recombinant DNA technology.
Fiblast is a bFGF ( basic fibroblast growth factor ) introduced by KAKEN from Scios Inc. ( head office: Mountain View, California, US; chairman and CEO: Richard L. Casey ) under a licensing agreement. KAKEN has been conducting clinical studies in patients with intractable skin ulcers. This is the world’s first application for bFGF as a drug.
The number of intractable skin ulcer patients in Japan is presently estimated to be from 500,000 to 600,000, and the market for drugs to treat this disorder is in the order of 15 billion yen.
1. Information on bFGF
bFGF is a kind of protein called growth factor that stimulates the growth and differentiation of blood vessel, muscle, bone, nerve and other tissue cells and promotes the formation of new blood vessels. It is essential for healing of injury in the body.
KAKEN expects that it is effective for not only skin ulcers but a wider range of and diseases injury as well, including osteopathy ( bone fracture, osteoporosis, etc. ), ischemic heart disease ( myocardial infarction, etc. ) and nerve injury.
2. Information on Scios Inc.
Scios is a biotechnology venture business founded in California in 1982 under the name of California Biotechnology ( Calbio ). Besides bFGF, Scios is presently conducting research and development of therapeutic drugs for other acute diseases ( heart and kidney failure ).