IclaprimTreatment for Skin and Structure Infection
FDA Accepts Iclaprim NDA
Arpida Announces FDA Acceptance of the Iclaprim New Drug Application
REINACH, Switzerland, May 16, 2008 /PRNewswire-FirstCall/ -- Arpida Ltd. today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravenous iclaprim in the treatment of complicated Skin and Skin Structure Infections (cSSSI). Arpida completed the submission of the NDA to the agency in March 2008. FDA has assigned a standard ten month review to the iclaprim NDA and has established the Prescription Drug User Fee Act (PDUFA) action date for the NDA to be 16 January 2009.
Dr Jurgen Raths, CEO of Arpida Ltd. commented: "We are very pleased with the FDA's acceptance of our NDA. This marks another step towards our goal of launching iclaprim and providing a promising treatment option for patients suffering from serious or life-threatening infections. We look forward to continue to work with the US authorities to facilitate their review of the NDA. In the meantime, work on the European filing is progressing and we expect to submit the Marketing Authorisation Application in the EU around the middle of this year. Furthermore, we will increasingly focus on the build-up of a commercial structure."
The iclaprim NDA contains data from 15 clinical studies, including two well-controlled multinational pivotal Phase III trials (ASSIST-1 and ASSIST-2, in which approximately 1,000 patients were enrolled and treated). Patients enrolled in both Phase III trials exhibited high incidences of methicillin-resistant Staphylococcus aureus (MRSA). In these studies, iclaprim showed high clinical and microbiological cure rates and was well-tolerated with a safety profile which was compatible with treatment of patients with cSSSI.
About Arpida Ltd.
Arpida is a biopharmaceutical company with research facilities in Reinach, Switzerland and in the USA. It focuses on the discovery and development of novel drugs that seek to overcome the growing problem of microbial resistance. The most advanced compounds include an antibacterial under regulatory review and an antifungal in Phase III.
Arpida's leading product candidate is intravenous iclaprim, a potent antibacterial that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The clinical programme for the first indication, complicated skin and skin structure infections (cSSSI), has been completed. The submission of the NDA to the US FDA was completed in March 2008.
In December 2007, Arpida announced the enrolment of the first patients in a Phase II clinical study with intravenous iclaprim in the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare associated pneumonia (HCAP).
In January 2008, the US FDA granted authorisation to progress oral iclaprim into a Phase II 'intravenous-to-oral' switch trial. Iclaprim could be offered not only as an intravenous therapy for hospital use in acute situations, but also as an oral formulation, allowing early patient discharge followed by outpatient treatment. This switch could be a valuable instrument in reducing healthcare costs and enhancing patient comfort.
Arpida's fourth most advanced antibiotic programme, AR-709, targets upper and lower respiratory tract infections acquired in the community setting. AR-709 exhibited potent activity against a large panel of pneumococcal clinical isolates including those resistant to currently used drugs. Promising results of "first-in-man" studies with AR-709 were published in March 2007.
An additional compound, AR-2474, has achieved in vivo proof of concept. AR-2474 has been shown to be effective in eradicating pathogens in preclinical models of skin infection and nasal carriage.
Apart from the antibiotic programmes, Arpida has an innovative antifungal therapy (TLT) which is in Phase III clinical trials in Europe, targeting onychomycosis.
Moreover, the company has several other leads in optimisation and additional discovery programmes derived from its own discovery platform at various research stages.
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.
Arpida contacts: Dr Jurgen Raths, 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
CONTACT: Arpida contacts: Dr Jurgen Raths, 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: May 2008
- FDA Issues Complete Response Letter for Iclaprim - January 20, 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 Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections - March 19, 2008