IclaprimTreatment for Skin and Structure Infection
NDA for Iclaprim Submitted to FDA
Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections
REINACH, Switzerland, March 19, 2008 /PRNewswire-FirstCall/ -- Arpida Ltd. today reported that it has submitted a New Drug Application (NDA) in an electronic format for intravenous iclaprim for the treatment of complicated Skin and Skin Structure Infections (cSSSI) to the US Food and Drug Administration (FDA). Arpida has requested a Priority designation for the review of the NDA. Iclaprim is a synthetic diaminopyrimidine which exhibits a rapidly bactericidal action against an extended spectrum of pathogens, including multidrug-resistant bacteria.
The iclaprim NDA contains data from 15 clinical studies, including two adequate and 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 two independent Phase III trials, intravenous iclaprim achieved the pre-specified primary endpoint. In the studies, iclaprim was well-tolerated with a safety profile which was compatible with treatment of patients with cSSSI.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "We are convinced that iclaprim - if approved - has the properties to become a successful drug in the hospital antibiotics market. In this market there is a clear need for novel therapies, as several of the currently available drugs are faced with reduced efficacy, emerging resistance or worrying side effects."
Dr Khalid Islam, President and CEO of Arpida Ltd. added: "We're very proud of reaching this important milestone. Arpida has successfully progressed iclaprim from an early preclinical stage all the way to regulatory filing. This achievement is a credit to our team at Arpida as well as to our external partners. We look forward to working closely with the FDA on their review of our submission."
In addition to the cSSSI indication, intravenous iclaprim is also being developed for the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens. This programme is currently in Phase II. Moreover, an oral formulation of iclaprim is currently in Phase II clinical trials as a potential step-down therapy following initial intravenous treatment.
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.
CONTACT: Arpida contacts: Dr Khalid Islam, 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: March 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 Announces FDA Acceptance of the Iclaprim New Drug Application - May 16, 2008