Kaken Submits NDA For Fiblast In Japan

Scios' Asian partner Kaken Pharmaceuticals has submitted a New Drug Application to the Japanese Ministry of Health and Welfare for approval of Scios' basic fibroblast growth factor Fiblast (trafermin) for wound-healing in recalcitrant dermal ulcers. This is the first NDA for a Scios product.

The active component in Fiblast is naturally produced in the body and stimulates blood vessel formation and tissue repair. Patents for the manufacture, use and sale of recombinant bFGF have been granted in the USA, Europe and Japan. Kaken has the rights to develop and market the product in Japan, Korea, Hong Kong and China, for all potential indications, including stroke, for which it is in Phase I/II trials. Scios will receive royalties on sales in these countries.