IclaprimTreatment for Skin and Structure Infection
Complete Response Letter for Iclaprim
FDA Issues Complete Response Letter for Iclaprim
FDA Requests an Additional Clinical Study Prior to Approval
REINACH Switzerland, January 19, 2009 /PRNewswire-FirstCall/ -- Arpida Ltd. announces today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for intravenous iclaprim for the treatment of complicated skin and skin structure infections (cSSSI). The FDA indicated in its letter that they cannot approve the application for iclaprim in its current form and that additional clinical data are required to demonstrate efficacy in order to gain approval.
President and CEO Dr Jurgen Raths commented: "After the negative recommendation of the Advisory Committee of last November, the FDA opinion comes as no surprise. We now aim to develop a viable roadmap to approval in close consultation with the FDA. The drastic cost saving measures that we've recently implemented should buy us sufficient time to consider and develop strategic options for progressing iclaprim's development."
In its letter to Arpida, the FDA stated the Company's NDA did not demonstrate the efficacy of iclaprim for treatment of cSSSI within an acceptable non-inferiority margin. The FDA requires additional data to assess the benefits and risks of iclaprim for cSSSI.
To address this deficiency, the FDA requests an additional study or studies to demonstrate effectiveness of iclaprim. An additional study showing non-inferiority of iclaprim to an approved comparator may be sufficient to meet this requirement, depending on the study results.
Moreover, the FDA raised questions related to the drug product, which Arpida believes can be rapidly addressed. In addition, the resubmission should provide updated safety data and labelling information.
Arpida today also announces that the restructuring that was announced late last year, is progressing as planned. In addition, the Board of Directors has decided to decrease its membership in order to reflect the reduced size of the company. In this context, Dr Khalid Islam tendered his resignation and Prof. Axel Kleemann has announced that he will not stand for re-election at the next shareholders' meeting. Arpida wishes to thank both Board members for their valuable contributions. Dr Islam will continue to be available 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 similar expressions. Such forward-looking statements are subject to known and unknown risks, uncertainties and other factors which may result in a substantial divergence between the actual results, financial situation, development or performance of the company and those explicitly or implicitly presumed in these statements. Against the background of these uncertainties readers should not place undue reliance on forward-looking statements. The company assumes no responsibility to update forward-looking statements or to adapt them to future events or developments.
This statement was also released in German. The English original is the binding version.
CONTACT: 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
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Posted: January 2009
- Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome - November 21, 2008
- Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008 - October 14, 2008
- Arpida Announces FDA Acceptance of the Iclaprim New Drug Application - May 16, 2008
- Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections - March 19, 2008