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.
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
|SOURCE Arpida Ltd|
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