Navigation Links
Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections

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, intravenous iclaprim is also being developed for the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens. This programme is currently in Phase II. Moreover, an oral formulation of iclaprim is currently in Phase II clinical trials as a potential step-down therapy following initial intravenous treatment.

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 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.

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 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. 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 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.

Arpida contacts:

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
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Arpida Announces Full Year 2007 Financial Results
2. Arpida Provides Update on Progress of New Drug Application for Intravenous Iclaprim
3. Arpida Reports Progress in Pivotal Phase III Trial With TLT Treatment in Onychomycosis
4. Arpida Receives Green Light From US FDA for Phase II Efficacy Trial With Oral Iclaprim
5. Arpida-Supported CME Symposium Available Online
6. Arpida Presents Data on Iclaprim at Scientific Congress in Germany
7. Arpida Presents Preclinical Data on AR-2474 at ICAAC
8. Arpida Presents Preclinical and Clinical Data on Iclaprim at ICAAC
9. Arpida Invited to Present Preclinical Data on Novel Topical Antibiotic AR-2474 at ICAAC
10. Arpida Interim Results for six Months to 30 June 2007
11. AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Major Depressive Disorder
Post Your Comments:
(Date:11/25/2015)... 25, 2015 The Global ... a professional and in-depth study on the current ... (Logo: ) , The ... including definitions, classifications, applications and industry chain structure. ... international markets including development trends, competitive landscape analysis, ...
(Date:11/24/2015)... N.J. (PRWEB) , ... November 24, 2015 , ... The ... the recipient of the 2016 USGA Green Section Award. Presented annually since 1961, the ... through his or her work with turfgrass. , Clarke, of Iselin, N.J., ...
(Date:11/24/2015)... VANCOUVER , Nov. 24, 2015 /CNW/ - iCo ... ICOTF), today reported financial results for the quarter ... are expressed in Canadian dollars and presented under ... the United States ," said Andrew ... "These advancements regarding iCo-008 are not only value ...
(Date:11/24/2015)... - Aeterna Zentaris Inc. (NASDAQ:  AEZS) (TSX: AEZ) (the "Company"), ... Toronto Stock Exchange, confirms that as of the date ... that would cause the recent movements in the Company,s ... About Aeterna Zentaris Inc. . ... Zentaris is a specialty biopharmaceutical company engaged in developing ...
Breaking Biology Technology:
(Date:10/29/2015)... Oct. 29, 2015  The J. Craig Venter Institute ... "DNA Synthesis and Biosecurity: Lessons Learned and Options for ... Health and Human Services guidance for synthetic biology providers ... --> --> Synthetic ... the potential to pose unique biosecurity threats. It now ...
(Date:10/29/2015)... Oct. 29, 2015 Today, LifeBEAM ... partnership with 2XU, a global leader in technical ... smart hat with advanced bio-sensing technology. The hat ... to monitor key biometrics to improve overall training ... the two companies will bring together the most advanced ...
(Date:10/26/2015)... and LAS VEGAS , Oct. ... Labs , an innovator in modern authentication and a ... announced the launch of its latest version of the ... enabling organizations to use standards-based authentication that supports existing ... S3 Authentication Suite is ideal for organizations deploying customer-facing ...
Breaking Biology News(10 mins):