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Arpida Comments on FDA's Anti-infective Drugs Advisory Committee Outcome
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REINACH, Switzerland, November 20 /PRNewswire-FirstCall/ -- Arpida (SWX:ARPN) announced today that the Anti-infective Drugs Advisory Committee of theU.S. Food and Drug Administration (FDA) has voted 17 to 2 against theapproval of intravenous iclaprim, an antibiotic currently in development forthe treatment of patients with complicated skin and skin structure infections(cSSSIs), including those caused by methicillin-resistant Staphylococcusaureus (MRSA).
Arpida remains confident in the efficacy and safety of intravenousiclaprim and its potential in combating serious resistant infections.Iclaprim has been tested against both vancomycin and linezolid, and incombined Phase III studies that included nearly 1,000 patients with cSSSI,iclaprim has been shown to have high cure rates, exceeding 90 percent in thePer-Protocol population. Iclaprim has demonstrated potent bactericidal(killing) activity against MRSA and an extended range of resistant pathogens,with a well tolerated side-effect profile. Arpida is fully committed toiclaprim's development and will continue to work with the FDA to address anyquestions related to iclaprim in anticipation of the drug's Prescription DrugUser Fee Act (PDUFA) goal date of January 16, 2009.
In addition to the FDA regulatory application, the European MedicinesAgency (EMEA) accepted intravenous iclaprim for review August 2008. InSeptember 2008, Arpida filed a New Drug Submission for intravenous iclaprimin Canada.
Arpida continues to study the potential of iclaprim, includinginvestigation of an oral formulation. In early 2008, Arpida received FDAapproval to conduct a Phase II iclaprim 'intravenous-to-oral' switch trial inpatients with cSSSI. Patient enrolment was completed in September 2008 andresults are expected in December 2008.
Additional studies are ongoing worldwide to investigate the use ofintravenous iclaprim in hospital-acquired pneumonia, ventilator-associatedpneumonia and healthcare-associated pneumonia.
Committed to the future development and commercialization of iclaprim,Arpida has anticipated potential scenarios and instituted judicious businessplans that allow for continued development of its portfolio of products.Arpida continues to work in close collaboration with regulatory authoritiesto obtain intravenous iclaprim market authorization in the United States andEurope.
About MRSA
Methicillin-resistant Staphylococcus aureus (MRSA) is a type of bacteriathat is resistant to most commonly available antibiotics.(i) MRSA infectionsoccur most frequently among persons who have weakened immune systems inhospitals and healthcare facilities; however community-associated MRSAinfections, such as abscesses, boils, and other pus-filled lesions, areincreasingly being diagnosed in healthy people who have not been recentlyhospitalized or have undergone medical procedure.(iii), (ii)The most commonantibiotic used to treat MRSA infections is vancomycin, but recent evidencesuggests resistance to vancomycin is on the rise.(iii), (iv)
Approximately 2.3 million people in the United States acquire MRSA and89.4 million people are colonized with S. aureus annually, according to theCenters for Disease Control and Prevention (CDC).(i), (v) An estimated292,000 hospitalizations with a diagnosis of S. aureus infection occurannually in U.S. hospitals and, of these, approximately 126,000hospitalizations are related to MRSA.(vi) MRSA is responsible for an averageof 94,000 life-threatening infections and 18,650 deaths each year in theUnited States.(vii)
About Iclaprim
Iclaprim is an antibiotic currently in development for the treatment ofserious infections requiring hospitalization caused by Gram-positivebacteria, including those caused by MRSA. Iclaprim was designed to meet agrowing medical need for additional treatment options to combat resistantinfections and is the first antibiotic in the dihydrofolate reductase (DHFR)selective inhibitor class to demonstrate efficacy against cSSSIs caused byMRSA. The DHFR class has been proven safe and effective in more than fourdecades of clinical use.
About Arpida
Arpida (SWX: ARPN) is a biopharmaceutical company headquartered inReinach, Switzerland with operations in Switzerland and the United States. Itfocuses on the discovery, development and commercialization of novel drugsfor the treatment of microbial infections. Arpida has a fully integratedplatform for the discovery and development of drug candidates to address theincreasing prevalence of resistance of bacteria, such asmethicillin-resistant Staphylococcus aureus (MRSA), to existing antibiotictherapies. Arpida is currently developing an iclaprim oral formulation as astep-down therapy after intravenous therapy. Apart from the flagship iclaprimprogram, Arpida has an innovative antifungal treatment in Phase III clinicaldevelopment 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 similarexpressions. Such forward-looking statements are subject to known and unknownrisks, uncertainties and other factors which may result in a substantialdivergence between the actual results, financial situation, development orperformance of the company and those explicitly or implicitly presumed inthese statements. Against the background of these uncertainties readersshould not place undue reliance on forward-looking statements. The companyassumes no responsibility to update forward-looking statements or to adaptthem to future events or developments.
(i) Centers for Disease Control and Prevention Web site.Healthcare-Associated Methicillin Resistant Staphylococcus aureus (HA-MRSA)Overview. Available at http://www.cdc.gov/ncidod/dhqp/ar_MRSA.html. AccessedOctober 22, 2008.
(ii) Centers for Disease Control and Prevention Web site.Community-Associated Methicillin Resistant Staphylococcus aureus (CA-MRSA)Overview. Available at http://www.cdc.gov/ncidod/dhqp/ar_mrsa_ca.html.Accessed October 22, 2008.
(iii) Sakoulas, G et al. Clinical Infectious Diseases 2006; 42: S40-S50.
(iv) Tenover F, Moellering RC Jr. Clinical Infectious Diseases 2007; 44:1208-15.
(v) Centers for Disease Control and Prevention Web site. S. aureus andMRSA Surveillance Summary 2007. Available athttp://www.cdc.gov/ncidod/dhqp/ar_mrsa_surveillanceFS.html. Accessed October22, 2008.
(vi) Kuehnert MJ et al. Emerging Infectious Diseases 2005; 11: 868-72.
(vii) Klevens, RM et al. Journal of the American Medical Association.2007; 298: 1763-71.
Media contacts: Dr Jürgen 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: +41-61-417-96-83SOURCE Arpida Ltd.
In addition to the FDA regulatory application, the European MedicinesAgency (EMEA) accepted intravenous iclaprim for review August 2008. InSeptember 2008, Arpida filed a New Drug Submission for intravenous iclaprimin Canada.
Arpida continues to study the potential of iclaprim, includinginvestigation of an oral formulation. In early 2008, Arpida received FDAapproval to conduct a Phase II iclaprim 'intravenous-to-oral' switch trial inpatients with cSSSI. Patient enrolment was completed in September 2008 andresults are expected in December 2008.
Additional studies are ongoing worldwide to investigate the use ofintravenous iclaprim in hospital-acquired pneumonia, ventilator-associatedpneumonia and healthcare-associated pneumonia.
Committed to the future development and commercialization of iclaprim,Arpida has anticipated potential scenarios and instituted judicious businessplans that allow for continued development of its portfolio of products.Arpida continues to work in close collaboration with regulatory authoritiesto obtain intravenous iclaprim market authorization in the United States andEurope.
About MRSA
Methicillin-resistant Staphylococcus aureus (MRSA) is a type of bacteriathat is resistant to most commonly available antibiotics.(i) MRSA infectionsoccur most frequently among persons who have weakened immune systems inhospitals and healthcare facilities; however community-associated MRSAinfections, such as abscesses, boils, and other pus-filled lesions, areincreasingly being diagnosed in healthy people who have not been recentlyhospitalized or have undergone medical procedure.(iii), (ii)The most commonantibiotic used to treat MRSA infections is vancomycin, but recent evidencesuggests resistance to vancomycin is on the rise.(iii), (iv)
Approximately 2.3 million people in the United States acquire MRSA and89.4 million people are colonized with S. aureus annually, according to theCenters for Disease Control and Prevention (CDC).(i), (v) An estimated292,000 hospitalizations with a diagnosis of S. aureus infection occurannually in U.S. hospitals and, of these, approximately 126,000hospitalizations are related to MRSA.(vi) MRSA is responsible for an averageof 94,000 life-threatening infections and 18,650 deaths each year in theUnited States.(vii)
About Iclaprim
Iclaprim is an antibiotic currently in development for the treatment ofserious infections requiring hospitalization caused by Gram-positivebacteria, including those caused by MRSA. Iclaprim was designed to meet agrowing medical need for additional treatment options to combat resistantinfections and is the first antibiotic in the dihydrofolate reductase (DHFR)selective inhibitor class to demonstrate efficacy against cSSSIs caused byMRSA. The DHFR class has been proven safe and effective in more than fourdecades of clinical use.
About Arpida
Arpida (SWX: ARPN) is a biopharmaceutical company headquartered inReinach, Switzerland with operations in Switzerland and the United States. Itfocuses on the discovery, development and commercialization of novel drugsfor the treatment of microbial infections. Arpida has a fully integratedplatform for the discovery and development of drug candidates to address theincreasing prevalence of resistance of bacteria, such asmethicillin-resistant Staphylococcus aureus (MRSA), to existing antibiotictherapies. Arpida is currently developing an iclaprim oral formulation as astep-down therapy after intravenous therapy. Apart from the flagship iclaprimprogram, Arpida has an innovative antifungal treatment in Phase III clinicaldevelopment 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 similarexpressions. Such forward-looking statements are subject to known and unknownrisks, uncertainties and other factors which may result in a substantialdivergence between the actual results, financial situation, development orperformance of the company and those explicitly or implicitly presumed inthese statements. Against the background of these uncertainties readersshould not place undue reliance on forward-looking statements. The companyassumes no responsibility to update forward-looking statements or to adaptthem to future events or developments.
(i) Centers for Disease Control and Prevention Web site.Healthcare-Associated Methicillin Resistant Staphylococcus aureus (HA-MRSA)Overview. Available at http://www.cdc.gov/ncidod/dhqp/ar_MRSA.html. AccessedOctober 22, 2008.
(ii) Centers for Disease Control and Prevention Web site.Community-Associated Methicillin Resistant Staphylococcus aureus (CA-MRSA)Overview. Available at http://www.cdc.gov/ncidod/dhqp/ar_mrsa_ca.html.Accessed October 22, 2008.
(iii) Sakoulas, G et al. Clinical Infectious Diseases 2006; 42: S40-S50.
(iv) Tenover F, Moellering RC Jr. Clinical Infectious Diseases 2007; 44:1208-15.
(v) Centers for Disease Control and Prevention Web site. S. aureus andMRSA Surveillance Summary 2007. Available athttp://www.cdc.gov/ncidod/dhqp/ar_mrsa_surveillanceFS.html. Accessed October22, 2008.
(vi) Kuehnert MJ et al. Emerging Infectious Diseases 2005; 11: 868-72.
(vii) Klevens, RM et al. Journal of the American Medical Association.2007; 298: 1763-71.
Media contacts: Dr Jürgen 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: +41-61-417-96-83SOURCE Arpida Ltd.
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