The first modules of the NDA package are ready and will be filed before year-end 2007. The remaining modules are expected to be transferred and filing is forecast to be completed by the end of February 2008.
Dr Khalid Islam, President and CEO of Arpida Ltd., commented: "We are pleased with the progress made across the several different programmes.
Firstly, initiation of patient enrolment in the Phase II trial with intravenous iclaprim in HAP/VAP/HCAP provides a good basis for the completion of the trial within the planned timelines. HAP/VAP/HCAP is a serious, life-threatening condition with a high medical need. We believe that iclaprim could have a high potential in this indication based on its potent and bactericidal action on MRSA and its good distribution in those lung compartments where the key respiratory pathogens reside."
Dr Islam added: "Moreover, we are very pleased with the results of the ascending dose trial with oral iclaprim, which show a good tolerability at high doses. We are now working to complete the Phase I programme while at the same time discussing with the regulatory authorities regarding the potential next steps in the development path of oral iclaprim.
Work on the NDA for intravenous iclaprim in cSSSI is progressing well. We expect to file the first modules of the package before year-end and complete the filing by the end of February 2008. After finalising the NDA filing, our next steps will focus on the preparation of the commercial launch of iclaprim."
Arpida will host a conference call to discuss these recent developments, today, 11 December 2007, at 3 pm CET. The dial-in numbers are:
|SOURCE Arpida Ltd|
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