This application is the first marketing approval submission for Orapem worldwide, and the first NDA submission the company has made.
The Orapem submission is primarily based on data from eleven phase III clinical trials which assessed the clinical and microbiological efficacy as well as the safety and tolerability profile of Orapem in treating respiratory tract and skin infections. The safety database included more than 5,000 Orapem treated patients from clinical trials.
“The submission of the Orapem NDA represents a substantial step in the Company’s growth as we now expand our focus toward commercialization,” said Kenneth Collins, president and CEO of Replidyne.
Replidyne acquired exclusive rights to Orapem in March 2004 from Daiichi Asubio Pharma for the US and Canada and an exclusive option to the rest of the world, except Japan.