Navigation Links
Arpida Provides Update on Progress of New Drug Application for Intravenous Iclaprim

REINACH, Switzerland, February 26 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) today reported that the rolling submission of the New Drug Application (NDA) for intravenous iclaprim in its first indication, complicated Skin and Skin Structure Infections (cSSSI) will be completed within the next few weeks.

Arpida has agreed with the U.S. Food and Drug Administration (FDA) to file the NDA in a rolling process. Using a 'rolling NDA' allows modules within the overall package to be filed individually. Arpida has further agreed to file the NDA in an electronic format. Both the rolling NDA and the electronic format could potentially facilitate the review process.

Dr Khalid Islam, President and CEO of Arpida Ltd., commented: "Completing the submission of the NDA as soon as possible, while at the same time maintaining high standards of quality, remains our highest priority. Unfortunately, some of the data to be included in the NDA package were delivered later than anticipated. These delays were amplified by the additional processing steps that need to be taken for the electronic format in which we are filing, such as the incorporation of hyperlinks between the different parts of this huge and complex data package. We have only limited reference data regarding such projects and we underestimated the magnitude of the additional processing steps. Our development team and our external partners have been doing their utmost to complete the project within the February timeline. Rushing through the final processing procedure could jeopardise the quality. We strongly believe that safeguarding a high quality level at this crucial stage of iclaprim's development process is in the best interest of our stakeholders in the longer term. Based on the current status of the project, we anticipate the filing to be completed within the next few weeks."

Conference Call

Arpida will host a conference call to discuss this news release, 27

February 2008, at 3 pm CET. The dial-in numbers are:

+41(0)91-610-56-00 (Europe)

+44(0)207-107-0611 (UK)

+1(1)-866-291-4166 (USA)

The conference call (Call ID 16607, followed by the #) will be available

for play-back for 48 hours after the call by dialling:

+41(0)91-612-43-30 (Europe)

+44(0)207-108-6233 (UK)

+1(1)866-416-2558 (USA)

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 close to NDA-filing and an antifungal in Phase III.

Arpida's leading product candidate is intravenous iclaprim, a potent late-stage antibiotic 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 NDA-filing process for intravenous iclaprim in this indication in the USA is ongoing and expected to be completed in the next few weeks.

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 should 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 highly 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 Interim Results for six Months to 30 June 2007
2. Arpida Invited to Present Preclinical Data on Novel Topical Antibiotic AR-2474 at ICAAC
3. Arpida Presents Preclinical and Clinical Data on Iclaprim at ICAAC
4. Arpida Presents Preclinical Data on AR-2474 at ICAAC
5. Arpida Presents Data on Iclaprim at Scientific Congress in Germany
6. Arpida-Supported CME Symposium Available Online
7. Arpida Receives Green Light From US FDA for Phase II Efficacy Trial With Oral Iclaprim
8. Arpida Reports Progress in Pivotal Phase III Trial With TLT Treatment in Onychomycosis
9. CardioDynamics Provides 2007 Shareholder Meeting Update
10. Pressure BioSciences, Inc. Reports Second Quarter 2007 Financial Results and Provides Business Update
11. NxStage Medical Provides Update on Medisystems Acquisition
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... Jessica Richman and Zachary ... in their initial angel funding process. Now, they are paying it forward to ... early stage investments in the microbiome space. In this, they join other ...
(Date:11/24/2015)... ... November 24, 2015 , ... The United States Golf Association (USGA) today announced ... Section Award. Presented annually since 1961, the USGA Green Section Award recognizes an individual’s ... , Clarke, of Iselin, N.J., is an extension specialist of turfgrass pathology ...
(Date:11/24/2015)... DIEGO , Nov. 24, 2015 Halozyme Therapeutics, Inc. ... Healthcare Conference in New York on Wednesday, ... Helen Torley , president and CEO, will provide a corporate ... New York at 1:00 p.m. ET/10:00 a.m. PT ... and investor relations, will provide a corporate overview. --> ...
(Date:11/24/2015)... Mass. (PRWEB) , ... November 24, 2015 , ... ... to maintain healthy metabolism. But unless it is bound to proteins, copper is ... of Health (NIH), researchers at Worcester Polytechnic Institute (WPI) will conduct a systematic ...
Breaking Biology Technology:
(Date:11/18/2015)... PHILADELPHIA , Nov. 18, 2015  As new ... in children, doctors and other healthcare providers face challenges ... counsel families and patients. In addition, as more children ... into a patient,s adulthood and old age. ... The Children,s Hospital of Philadelphia (CHOP) . ...
(Date:11/17/2015)... Paris from 17 th until ... from 17 th until 19 th November ... has invented the first combined scanner in the world which scans ... Until now two different scanners were required: one for passports ... on the same surface. This innovation is an ideal solution ...
(Date:11/17/2015)... LIVERMORE, Calif. , Nov. 17, 2015  Vigilant ... has joined its Board of Directors. ... Vigilant,s Board after recently retiring from the partnership at ... owning 107 companies with over $140 Billion in revenue.  ... performance improvement across all the TPG companies, from 1997 ...
Breaking Biology News(10 mins):