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Arpida Announces Full Year 2008 Financial Results
Date:2/25/2009

p a roadmap to approval.

The regulatory filing in the European Union is ongoing. Arpida has received an intermediate report from the European Medicines Agency (EMEA) containing the findings of the review carried out so far. The company is working closely with EMEA to address the topics it has put forward.

The Canadian filing is currently not being pursued.

Oral iclaprim in cSSSI - in-depth analysis ongoing for further design of development plan

In December 2008, Arpida announced the top-line results of a Phase II "intravenous-to-oral" switch trial with iclaprim in patients with cSSSI. In parallel with the Phase II trial, the last ongoing study of the Phase I programme has been closed.

Based on the review to date, Arpida expects that further development work will be required in order to better understand the effect of orally administrated iclaprim on liver enzymes and to explore optimal dosing regimens.

Other programmes:

In December 2008, a re-alignment of activities was initiated. The action plan to reduce costs impacts the development programmes in different ways:

    - study stopped: Phase II with intravenous iclaprim in HAP/VAP/HCAP
    - late preclinical studies stopped: AR-709 and AR-2474
    - trial ongoing, further patient enrolment stopped: Phase III study with
      TLT in onychomycosis.

A PDF-file containing the preliminary 2008 annual report (in English) is available on our website (http://www.arpida.com) starting 25 February 2009, noon.

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
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SOURCE Arpida Ltd
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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. Arpida Provides Update on Progress of New Drug Application for Intravenous Iclaprim
10. Arpida Announces Full Year 2007 Financial Results
11. Arpida Submits New Drug Application for Intravenous Iclaprim for Treatment of Skin Infections
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