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Arpida has agreed with the U.S. Food and Drug Administration (FDA) tofile the NDA in a rolling process. Using a 'rolling NDA' allows moduleswithin the overall package to be filed individually. Arpida has furtheragreed to file the NDA in an electronic format. Both the rolling NDA and theelectronic format could potentially facilitate the review process.
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Dr Khalid Islam, President and CEO of Arpida Ltd., commented: "Completingthe submission of the NDA as soon as possible, while at the same timemaintaining high standards of quality, remains our highest priority.Unfortunately, some of the data to be included in the NDA package weredelivered later than anticipated. These delays were amplified by theadditional processing steps that need to be taken for the electronic formatin which we are filing, such as the incorporation of hyperlinks between thedifferent parts of this huge and complex data package. We have only limitedreference data regarding such projects and we underestimated the magnitude ofthe additional processing steps. Our development team and our externalpartners have been doing their utmost to complete the project within theFebruary timeline. Rushing through the final processing procedure couldjeopardise the quality. We strongly believe that safeguarding a high qualitylevel at this crucial stage of iclaprim's development process is in the bestinterest of our stakeholders in the longer term. Based on the current statusof the project, we anticipate the filing to be completed within the next fewweeks."
About Arpida Ltd.
Arpida (SWX: ARPN) is a biopharmaceutical company with researchfacilities in Reinach, Switzerland and in the USA. It focuses on thediscovery and development of novel drugs that seek to overcome the growingproblem of microbial resistance. The most advanced compounds include anantibacterial close to NDA-filing and an antifungal in Phase III.
Arpida's leading product candidate is intravenous iclaprim, a potentlate-stage antibiotic that targets severe infections requiring hospitaltreatment, including those caused by methicillin-resistant Staphylococcusaureus (MRSA). The clinical programme for the first indication, complicatedskin and skin structure infections (cSSSI), has been completed. TheNDA-filing process for intravenous iclaprim in this indication in the USA isongoing and expected to be completed in the next few weeks.
In December 2007, Arpida announced the enrolment of the first patients ina Phase II clinical study with intravenous iclaprim in the treatment ofpatients with hospital-acquired pneumonia (HAP), ventilator-associatedpneumonia (VAP) or healthcare associated pneumonia (HCAP).
In January 2008, the US FDA granted authorisation to progress oraliclaprim into a Phase II 'intravenous-to-oral' switch trial. Iclaprim couldbe offered not only as an intravenous therapy for hospital use in acutesituations, but also as an oral formulation, allowing early patient dischargefollowed by outpatient treatment. This switch should be a valuable instrumentin reducing healthcare costs and enhancing patient comfort.
Arpida's fourth most advanced antibiotic programme, AR-709, targets upperand lower respiratory tract infections acquired in the community setting.AR-709 exhibited potent activity against a large panel of pneumococcalclinical isolates including those resistant to currently used drugs.Promising results of "first-in-man" studies with AR-709 were published inMarch 2007.
An additional compound, AR-2474, has achieved in vivo proof of concept.AR-2474 has been shown to be highly effective in eradicating p
