IclaprimTreatment for Skin and Structure Infection
Iclaprim NDA Review
Arpida Announces Review of Iclaprim NDA by FDA Advisory Committee in November 2008
REINACH, Switzerland, October 14, 2008 /PRNewswire-FirstCall/ -- Arpida Ltd. today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that the agency's Anti-Infective Drugs Advisory Committee will discuss the New Drug Application (NDA) for intravenous iclaprim in complicated Skin and Skin Structure Infections (cSSSI) during its meeting on 18-20 November 2008. An Advisory Committee can be requested by FDA as part of the review process of an NDA or supplemental NDA.
Iclaprim is a hospital antibiotic drug candidate with potent bactericidal (killing) activity against MRSA and an extended range of important pathogens. To date, Arpida has filed marketing applications for intravenous iclaprim in the treatment of complicated Skin and Skin Structure Infections in the U.S.A., Canada and the European Union.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: "We are delighted to have an opportunity to present iclaprim to leading experts in the anti-infective field and to discuss important features of our NDA with the Advisory Committee."
About Arpida Ltd.
Arpida is a biopharmaceutical company headquartered in Reinach, Switzerland with operations in Switzerland and the USA. It focuses on the discovery, development and commercialisation 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. The FDA has defined that the Prescription Drug User Fee Act (PDUFA) goal date will be 16 January 2009. Arpida submitted a Marketing Authorisation Application for intravenous iclaprim with EMEA in July 2008. EMEA notified that it had accepted the MAA for review in August 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 May 2008, Arpida announced the enrolment of the first patients in 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. Results of "first-in-man" studies with AR-709 were published in March 2007.
An additional antibacterial compound, AR-2474, has demonstrated 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: 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: October 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 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