REINACH, Switzerland, February 26 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today reported that the rolling submission of the New Drug Application (NDA) for intravenous iclaprim in its first indication, complicated Skin and Skin Structure Infections (cSSSI) will be completed within the next few weeks.
Arpida has agreed with the U.S. Food and Drug Administration (FDA) to file the NDA in a rolling process. Using a 'rolling NDA' allows modules within the overall package to be filed individually. Arpida has further agreed to file the NDA in an electronic format. Both the rolling NDA and the electronic format could potentially facilitate the review process.
Dr Khalid Islam, President and CEO of Arpida Ltd., commented:
"Completing the submission of the NDA as soon as possible, while at the
same time maintaining high standards of quality, remains our highest
priority. Unfortunately, some of the data to be included in the NDA package
were delivered later than anticipated. These delays were amplified by the
additional processing steps that need to be taken for the electronic format
in which we are filing, such as the incorporation of hyperlinks between the
different parts of this huge and complex data package. We have only limited
reference data regarding such projects and we underestimated the magnitude
of the additional processing steps. Our development team and our external
partners have been doing their utmost to complete the project within the
February timeline. Rushing through the final processing procedure could
jeopardise the quality. We strongly believe that safeguarding a high
quality level at this crucial stage of iclaprim's development process is in
the best interest of our stakeholders in the longer term. Based on the
current status of the project, we anticipate the filing to be completed
within the next few weeks."
Arpida will host a conference call to discuss this news release, 27
February 2008, at 3 pm CET. The dial-in numbers are:
The conference call (Call ID 16607, followed by the #) will be available
for play-back for 48 hours after the call by dialling:
About Arpida Ltd.
Arpida (SWX: ARPN) 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 close to NDA-filing and an antifungal in Phase III.
Arpida's leading product candidate is intravenous iclaprim, a potent late-stage antibiotic 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 NDA-filing process for intravenous iclaprim in this indication in the USA is ongoing and expected to be completed in the next few weeks.
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 should 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 highly 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.
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
|SOURCE Arpida Ltd.|
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