Replidyne faropenem NDA in 2005
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Replidyne will file an NDA for its oral antibiotic faropenem "later this year," the firm announces at the Biotechnology Industry Organization's investor conference Feb. 24. Replidyne is touting faropenem as having a broad spectrum of activity comparable to the quinolones with a safety profile similar to the beta-lactam class. The company believes the antibiotic market size will allow the drug to generate significant sales with a relatively small share. Bayer in-licensed faropenem from Daiichi Suntory but dropped it in 2002; Replidyne acquired rights in August 2004 (1Pharmaceutical Approvals Monthly September 2004, p. 16)...