Navigation Links
Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections
Date:3/19/2008

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
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3

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:
*Name:
*Comment:
*Email:
(Date:7/29/2014)... Cheshire Cat: Can a particle be separated from its ... Communications , published the results of the first Cheshire ... conducted by Chapman University in Orange, CA, and Vienna ... a cat without a grin," thought Alice in Wonderland, ... curious thing I ever saw in my life!" Alice,s ...
(Date:7/29/2014)... (PRWEB) July 29, 2014 Second generation biofuels ... imposed by fossil fuels. However, as natural gas is very ... as they are not as valuable as they could be ... the difficulty financing projects, has made it difficult for renewable ... projects get off the ground. For these reasons, certain companies ...
(Date:7/29/2014)... , July 29, 2014  Cannabis Science, ... cannabis formulation-based drug development and related consulting, applauds ... for taking a strong position in opposition to ... July 27, 2014 publication.  The New York Times ... articles this week exploring the issue called "High ...
(Date:7/29/2014)... Genera Energy Inc. , a ... supply chain advancements, has announced the deployment of ... and Supply ASSURE™. Both systems were developed ... at consolidating and simplifying the entire process, managing ... feedstock end users. , “Through the Energy Grange ...
Breaking Biology Technology:The quantum Cheshire cat: Scientists separate a particle from its properties 2The quantum Cheshire cat: Scientists separate a particle from its properties 3The quantum Cheshire cat: Scientists separate a particle from its properties 4Renewable Waste Intelligence: Could Renewable Chemicals Be the Future for the Renewable Energy Industry? 2Cannabis Science, Inc. (CBIS) Applauds New York Times Editorial Board Stance on 'Repealing Prohibition, Again'; NYT Editorial Is Bell Weather of Change 2Cannabis Science, Inc. (CBIS) Applauds New York Times Editorial Board Stance on 'Repealing Prohibition, Again'; NYT Editorial Is Bell Weather of Change 3Genera Energy Introduces Proprietary Feedstock Management Systems 2Genera Energy Introduces Proprietary Feedstock Management Systems 3Genera Energy Introduces Proprietary Feedstock Management Systems 4
... Bioscience announced today that it will be participating in ... The conference will be held at the Frontier Airlines ... August 3, 2011. Roka will be located at booth ... introduce a novel molecular instrument platform for the detection ...
... -   Text-to-speech application enables researchers to listen ...  Elsevier, a world leading provider of scientific, technical ... of an audio reader application from iSpeech, provider of cloud-based ... . The iSpeech Audio Reader is the latest in a ...
... 2011 BioDelivery Sciences International, Inc. (Nasdaq: ... completed the randomized portion of its Phase 3 clinical ... for the treatment of moderate to severe chronic pain, ... "We are very pleased to have brought ...
Cached Biology Technology:iSpeech® Develops Audio Reader for Elsevier's SciVerse Applications 2iSpeech® Develops Audio Reader for Elsevier's SciVerse Applications 3iSpeech® Develops Audio Reader for Elsevier's SciVerse Applications 4BioDelivery Sciences Announces Completion of BEMA Buprenorphine Phase 3 Chronic Pain Study 2BioDelivery Sciences Announces Completion of BEMA Buprenorphine Phase 3 Chronic Pain Study 3
(Date:7/28/2014)... 100 drugs already approved by the U.S. Food and ... the growth of certain bacterial pathogens inside human cells, ... spotted fever. The findings, published in mBio , ... Microbiology, demonstrate a new way of identifying non-antibiotic drugs ... , A handful of drugs on the list inhibit ...
(Date:7/28/2014)... and organic compounds in hydrothermal environments are critical components ... for the deep biosphere, and may have implications for ... about how minerals influence organic reactions. A team ... a common mineral acts as a catalysts for specific ... solvents or expensive reagents. , At the heart of ...
(Date:7/28/2014)... Eight of the top 10 U.S. cities that have ... public inconveniences as frequent road closures, overwhelmed storm drains ... a new NOAA technical report. , This nuisance flooding, ... three U.S. coasts, between 300 and 925 percent since ... Nuisance Flood Frequency Changes around the United States, also ...
Breaking Biology News(10 mins):New route to identify drugs that can fight bacterial infections 2Mineral magic? Common mineral capable of making and breaking bonds 2Mineral magic? Common mineral capable of making and breaking bonds 3NOAA: 'Nuisance flooding' an increasing problem as coastal sea levels rise 2NOAA: 'Nuisance flooding' an increasing problem as coastal sea levels rise 3
... analysis, carbon dioxide removal could be used under certain ... but it would not replace the bulk of actual ... allows to separate emissions control from the time and ... important for climate protection," says lead-author Elmar Kriegler. "You ...
... Stem cells can be coaxed to grow into new ... the right molecular cues and room inside a water-loving ... By creating a three-dimensional checkerboardone with alternating highly connected ... adjusting the size of the micropattern could affect stem ...
... of Houston chemical and biomolecular engineering professor,s theories on ... Station (ISS). Professor Peter Vekilov received a grant ... solution nucleate, or form crystals. While researchers understand how ... they transform from liquid to crystal. Vekilov discovered ...
Cached Biology News:CO2 removal can lower costs of climate protection 2CO2 removal can lower costs of climate protection 3Stem cell proliferation and differentiation observed within hydrogel 2University of Houston engineering researcher's theories to be tested in space 2
Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
Bethyl Laboratories packages antibodies, conjugates and calibrators to provide quantitative ELISA kits. Each kit contains the following components, sufficient for 1000 single well assays....
Use our experts and resources to develop reagent systems for your applications....
Biology Products: