REINACH, Switzerland, March 19 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) 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, intraveno
|SOURCE Arpida Ltd|
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