Navigation Links
FDA Issues Complete Response Letter for Iclaprim
Date:1/19/2009

REINACH Switzerland, January 19 /PRNewswire-FirstCall/ -- Arpida Ltd. (SWX: ARPN) announces today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for intravenous iclaprim for the treatment of complicated skin and skin structure infections (cSSSI). The FDA indicated in its letter that they cannot approve the application for iclaprim in its current form and that additional clinical data are required to demonstrate efficacy in order to gain approval.

President and CEO Dr Jurgen Raths commented: "After the negative recommendation of the Advisory Committee of last November, the FDA opinion comes as no surprise. We now aim to develop a viable roadmap to approval in close consultation with the FDA. The drastic cost saving measures that we've recently implemented should buy us sufficient time to consider and develop strategic options for progressing iclaprim's development."

In its letter to Arpida, the FDA stated the Company's NDA did not demonstrate the efficacy of iclaprim for treatment of cSSSI within an acceptable non-inferiority margin. The FDA requires additional data to assess the benefits and risks of iclaprim for cSSSI.

To address this deficiency, the FDA requests an additional study or studies to demonstrate effectiveness of iclaprim. An additional study showing non-inferiority of iclaprim to an approved comparator may be sufficient to meet this requirement, depending on the study results.

Moreover, the FDA raised questions related to the drug product, which Arpida believes can be rapidly addressed. In addition, the resubmission should provide updated safety data and labelling information.

Arpida today also announces that the restructuring that was announced late last year, is progressing as planned. In addition, the Board of Directors has decided to decrease its membership in order to reflect the reduced size of the company. In this context, Dr Khalid Islam tendered his resignation and Prof. Axel Kleemann has announced that he will not stand for re-election at the next shareholders' meeting. Arpida wishes to thank both Board members for their valuable contributions. Dr Islam will continue to be available to the company as a senior consultant.

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.

This statement was also released in German. The English original is the binding version.

    Arpida contacts:
    Dr Jurgen 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: +41-61-417-96-83

'/>"/>
SOURCE Arpida Ltd.
Copyright©2009 PR Newswire.
All rights reserved

Related biology technology :

1. Cornerstone Therapeutics Provides Update on Integration Activities and Issues 2008 Revenue Guidance
2. Intellect Neurosciences, Inc. Issues Letter to Shareholders From Its Chairman and CEO
3. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on The Medical House PLC
4. BioLife Solutions Submits FDA Master File on HypoThermosol(R) Preservation and Storage Media for Cells, Tissues
5. OTC Financial Network Issues Corporate Profile on ProtoKinetix Inc.
6. FDA Issues Draft Guidance on Priority Review Vouchers
7. Resverlogix Issues a Management Statement
8. SectorWatch.biz Issues MarketStats on Agri-Biotech Equities YGYB, GRO, SEED, MON, ADM, and BG
9. Crystal Research Associates, LLC Issues Executive Informational Overview(R) (EIO(R)) on Generex Biotechnology Corporation
10. BeaconEquity.com Issues Trade Alerts on Biotechnology Stocks: ELN, PFE, AMGN, DNA, BIIB, GILD
11. Arbitration Panel Issues Ruling in Distribution Dispute
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... June 23, 2016 , ... STACS DNA Inc., the sample tracking software ... State Crime Laboratory, has joined STACS DNA as a Field Application Specialist. , ... Tremblay, President and COO of STACS DNA. “In further expanding our capacity as a ...
(Date:6/23/2016)... 2016  Blueprint Bio, a company dedicated to identifying, ... community, has closed its Series A funding round, according ... "We have received a commitment from Forentis Fund ... to meet our current goals," stated Matthew Nunez ... to complete validation on the current projects in our ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... the Pennsylvania Convention Center and will showcase its product’s latest features from June ... be presenting a scientific poster on Disrupting Clinical Trials in The Cloud during ...
(Date:6/23/2016)...  Amgen (NASDAQ: AMGN ) today announced ... life sciences incubator to accelerate the development of new ... at QB3@953 was created to help high-potential life science ... early stage organizations - access to laboratory infrastructure. ... two "Amgen Golden Ticket" awards, providing each winner with ...
Breaking Biology Technology:
(Date:5/9/2016)... , UAE, May 9, 2016 ... it comes to expanding freedom for high net worth ... Even in today,s globally connected world, there is still ... system could ever duplicate sealing your deal with a ... second passports by taking advantage of citizenship via investment ...
(Date:4/26/2016)... , April 27, 2016 ... "Global Multi-modal Biometrics Market 2016-2020"  report to their ... , The analysts forecast the global ... of 15.49% during the period 2016-2020.  ... of sectors such as the healthcare, BFSI, transportation, ...
(Date:4/13/2016)...  IMPOWER physicians supporting Medicaid patients in ... standard in telehealth thanks to a new partnership with ... IMPOWER patients can routinely track key health measurements, such ... and, when they opt in, share them with IMPOWER ... local retail location at no cost. By leveraging this ...
Breaking Biology News(10 mins):