BioCentury
ARTICLE | Clinical News

Bisantrene regulatory update

February 24, 2014 8:00 AM UTC

Update said FDA granted Orphan Drug designation to UPI-928 to treat acute myelogenous leukemia (AML). Update said it is preparing an IND submission for the small molecule anthracene derivative. The product was approved as Zantrene in France for AML in 1990 but was never launched. The product was developed by Lederle Laboratories, part of American Cyanamid Co., which later merged with American Home Products Corp. American Home Products changed its name to Wyeth in 2002. Pfizer Inc. (NYSE:PFE, New York, N.Y.) acquired Wyeth in 2009. Update said it has filed patent protection on UPI-928 based upon new mechanisms of action, new formulations and methods of use that include combinatorial regimens. ...