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:1/15/2014)... 2014   Niagara Thermal Products is proud to ... Technologies LLC ("B3") as the critical thermal component supplier ... the Army Corps of Engineers.  B3 has developed the ... contaminants and destroys VOCs and other chemical pollutants, allergens ...
(Date:1/15/2014)... , Jan. 15, 2014 ­ RedBrick Health , ... change technology, today announces that EmblemHealth , the ... wellness company, is now providing the RedBrick Compass health ... program, to all of its members. EmblemHealth is among ...
(Date:1/15/2014)... January 15, 2014 Two champions of ... their sponsorship of an annual competition for middle and ... access to, innovative STEM study. The competition presents students ... Tests of Engineering Aptitude, Mathematics, and Sciences is ...
(Date:1/15/2014)... Freeslate, Inc ., the leading provider ... Limited, one of India’s top five pharmaceutical companies, has ... for high throughput solid form screening. , ... wide range of quality, affordable generic and branded formulations ...
Breaking Biology Technology:Niagara Thermal Products LLC Selected as Critical Supplier for Buffalo BioBlower Air Purification Systems 2EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 2EmblemHealth Selects RedBrick Health to Power its Next-Generation Health Engagement and Behavior Change System 3Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 2Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 3Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 4Technology Student Association Partners with Leaders in STEM Education Advocacy for Annual Competition 5Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 2Lupin Selects Freeslate’s CM Protégé PharmD System to Accelerate Polymorph Screening for Drug Development 3
... Toronto Stock Exchange Symbol: MS, EDMONTON, June 12 /PRNewswire-FirstCall/ - ... multiple sclerosis (MS), today,announced that Mr. Kevin Giese, President and CEO, ... in San Diego,California., WHEN: ... (PDT), WHERE: ...
... June 12 Repligen Corporation,(Nasdaq: RGEN ) today ... ended March 31, 2008. Total revenue for fiscal year ... fiscal year 2007,ended March 31, 2007, an increase of ... of Protein A and SecreFlo(R) product revenue., Operating ...
... concerning the,economic and business growth in the Tampa Bay ... To Connect Tampa Bay With Mexico, South America, ... cargo service every 60,days between the Port of Tampa ... and Iquitos, Peru. Headquartered in,Lima, Peruvian Amazon Line has ...
Cached Biology Technology:BioMS Medical to present at 2008 BIO International Convention 2Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results 2Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results 3Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results 4Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results 5Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results 6Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results 7Repligen Reports Fourth Quarter and Fiscal Year 2008 Financial Results 8Highlights of Economic and Business Growth in the Tampa Bay Region 2Highlights of Economic and Business Growth in the Tampa Bay Region 3
(Date:4/24/2014)... bacteria attack plants, they often inject harmful proteins ... suppress natural defenses. However, in some plants, bacteria ... a potential host. Now, researchers at the University ... that allows the bacteriaknown mostly for attacking tomatoesto ... natural anti-infective treatments that work with food-producing plants ...
(Date:4/24/2014)... April 24, 2014GEN Publishing recently introduced ... focusing on the application of OMICs technologies in ... sequencing, are beginning to transform medical care just ... the past decade-and-a-half. , "GEN,s editors and reporters ... genomics, metabolomics, transcriptomics, etc. etc. for years," said ...
(Date:4/24/2014)... 24, 2014D-ribose is a commercially important sugar used ... a starting compound for synthesizing riboflavin and several ... to increase the bacteria,s ability to produce ... efficient industrial-scale production of this valuable chemical, as ... , a peer-reviewed journal from Mary Ann Liebert, ...
Breaking Biology News(10 mins):Plants send out signals attracting harmful bacteria, MU study finds 2
... her research into single-cell organisms that affect oral health, ... molecular genetics at The University of Texas Health Science ... the 2011 American Society for Microbiology (ASM) Founders Distinguished ... made significant contributions to the society. Goldschmidt joined the ...
... The University of Pennsylvania, Dr. Ron Koder, assistant professor of ... of a team that devised a novel method for producing ... neuroglobin. He was recently awarded a three-year $1.3 million ... artificial blood that can be administered to injured troops on ...
... Biomedical Research Institute (Seattle BioMed) and Northwestern University Feinberg ... the effort to wipe out some of the most ... large structural genomics centers, they,ve experimentally determined 500 three-dimensional ... pathogens, which could potentially lead to new drugs, vaccines ...
Cached Biology News:UTHealth professor to receive service award from American Society for Microbiology 2CCNY professor gets grant to develop 'artificial blood' 2Milestone in fight against deadly disease 2Milestone in fight against deadly disease 3
Immunogen: C terminus [VQLKRSKNDSKPYC] of cardiac elav-type RNA-binding protein (ETR-3) Storage: -20 C, Avoid Freeze/Thaw Cycles...
Borosilicate Glass. Certified for use with the Beacon 2000 Systems, 1,000 tubes/case...
... The Beacon 2000 One-Step FP Standardization ... high and low fluorescence polarization values ... of the Beacon 2000 System. It ... polarization values generated by their instrument ...
Whole blood is collected from mice (Swiss Webster, 8-10 weeks old,either sex) and processed within 45 minutes of collection. The complement is then filtered and pooled on ice, bottled and stored at -...
Biology Products: