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Arpida Announces Posting of Briefing Documents for FDA Anti-Infective Drugs Advisory Committee Meeting on iclaprim



11/18/2008 10:06:28 AM

REINACH, Switzerland, November 18 /PRNewswire-FirstCall/ -- Arpida announced today that the U.S. Food and Drug Administration (FDA) has posted on its website briefing documents for the November 20, 2008 Anti-Infective Drugs Advisory Committee (AIDAC) meeting. The AIDAC will discuss and review Arpida's New Drug Application for iclaprim for the treatment of complicated skin and skin structure infection (cSSSI) caused by gram-positive organisms, including methicillin-resistant Staphylococcus aureus, or MRSA.

Briefing documents from the FDA and Arpida can be found on FDA's website at: http://www.fda.gov/ohrms/dockets/ac/acwhatsnew.htm

About Iclaprim

Iclaprim is an antibiotic currently in development for the treatment of serious infections requiring hospitalization caused by Gram-positive bacteria, including those caused by MRSA. Iclaprim was developed to meet a growing medical need for additional treatment options to combat resistant infections and is the first antibiotic in the dihydrofolate reductase (DHFR) selective inhibitor class to demonstrate efficacy against cSSSIs caused by MRSA. The DHFR class has been proven safe and effective in more than four decades of clinical use.

In March 2008, Arpida completed the U.S. filing of the NDA for intravenous iclaprim for the treatment of cSSSIs. The U.S. Food and Drug Administration defined a Prescription Drug User Fee Act (PDUFA) goal date of January 16, 2009. In August 2008, Arpida announced acceptance of its Marketing Authorization Application (MAA) for intravenous iclaprim for the treatment of cSSSIs for review by the European Medicines Agency. Arpida has also filed a marketing application in Canada.

In addition to the cSSSI indication, claprim is being studied in patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP). Arpida is also pursuing the development of an oral formulation of iclaprim which, if successful, could help reduce healthcare costs and enhance patient comfort.

About Arpida AG

Arpida is a biopharmaceutical company headquartered in Reinach, Switzerland with operations in Switzerland and the United States. It focuses on the discovery, development and commercialization of novel drugs for the treatment of microbial infections. Arpida has a fully integrated platform for the discovery and development of drug candidates to address the increasing prevalence of resistance of bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA), to existing antibiotic therapies. Apart from the flagship iclaprim program, Arpida has an innovative antifungal treatment in phase III clinical development as well as several earlier-stage programs (AR-709 and AR-2474).

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.


Read at BioSpace.com


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