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President and CEO Dr Jurgen Raths commented: "After the negativerecommendation of the Advisory Committee of last November, the FDA opinioncomes as no surprise. We now aim to develop a viable roadmap to approval inclose consultation with the FDA. The drastic cost saving measures that we'verecently implemented should buy us sufficient time to consider and developstrategic options for progressing iclaprim's development."
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In its letter to Arpida, the FDA stated the Company's NDA did notdemonstrate the efficacy of iclaprim for treatment of cSSSI within anacceptable non-inferiority margin. The FDA requires additional data to assessthe benefits and risks of iclaprim for cSSSI.
To address this deficiency, the FDA requests an additional study orstudies to demonstrate effectiveness of iclaprim. An additional study showingnon-inferiority of iclaprim to an approved comparator may be sufficient tomeet this requirement, depending on the study results.
Moreover, the FDA raised questions related to the drug product, whichArpida believes can be rapidly addressed. In addition, the resubmissionshould provide updated safety data and labelling information.
Arpida today also announces that the restructuring that was announcedlate last year, is progressing as planned. In addition, the Board ofDirectors has decided to decrease its membership in order to reflect thereduced size of the company. In this context, Dr Khalid Islam tendered hisresignation and Prof. Axel Kleemann has announced that he will not stand forre-election at the next shareholders' meeting. Arpida wishes to thank bothBoard members for their valuable contributions. Dr Islam will continue to beavailable to the company as a senior consultant.
This press release contains specific forward-looking statements, e.g.statements including terms like believe, assume, expect or similarexpressions. Such forward-looking statements are subject to known and unknownrisks, uncertainties and other factors which may result in a substantialdivergence between the actual results, financial situation, development orperformance of the company and those explicitly or implicitly presumed inthese statements. Against the background of these uncertainties readersshould not place undue reliance on forward-looking statements. The companyassumes no responsibility to update forward-looking statements or to adaptthem to future events or developments.
This statement was also released in German. The English original is thebinding version.Arpida contacts: Dr Jurgen Raths, President and CEO Tel: +41-61-417-96-60 Harry Welten, MBA, CFO and Senior Vice President, Tel: +41-61-417-96-65 Paul Verbraeken, Head of Corporate Communications, Tel: +41-61-417-96-83
SOURCE Arpida Ltd.
