Since inception, Arpida has chosen to capitalise research and development costs in its Statutory Accounts. In light of the announced company restructuring and the sharply reduced market capitalisation, this policy was reviewed. It was decided to write down 100% of the capitalised R&D expenses, resulting in an impairment charge in the Statutory Accounts. This does not impact the consolidated accounts, as R&D was never capitalised in these.
After completion of the restructuring that was initiated at the end of 2008, the burn rate is expected to fall to around CHF 1 million on average per month from the second quarter of 2009 onwards. Cash and financial investments are expected to be around CHF 17 million at year-end 2009.
Intravenous iclaprim in cSSSI - setback in regulatory process
In 2008, regulatory filings for intravenous iclaprim in complicated skin and skin structure infections (cSSSI) were submitted in the USA, the European Union and in Canada.
On 20 November 2008, the Anti-infective Drugs Advisory Committee of the
US Food and Drug Administration (FDA) voted 17 to 2 against the approval of
intravenous iclaprim for use in the treatment of patients with cSSSI. In
January 2009, Arpida received the FDA's Complete Response Letter. The FDA
indicated in its letter that they could not approve the application for
intravenous iclaprim in its current form and required additional clinical
data to demonstrate efficacy in order to gain approval. Arpida has initiated
a dialogue with external experts and the FDA to develo
|SOURCE Arpida Ltd|
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