Highlights 2007 to date
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Major pipeline progress:
Iclaprims second pivotal Phase III trial in complicated skin and skinstructure infections (cSSSI) also achieves its pre-specified primary endpoint
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Results from a Phase I study in special populations confirm iclaprimssafety profile
Late-stage antifungal therapy added to pipeline via acquisition of TLTMedical Ltd.
Harry Welten, MBA, Senior Vice President and CFO, said: In terms ofspending, the first half of 2007 developed in line with our expectations. Amajor financial highlight of the first half was the share offering of lastMarch. In a matter of a few hours, we successfully raised CHF 51.9 million,significantly boosting our cash position. Going forward, spending on the nowcompleted Phase III programme with intravenous iclaprim in cSSSI will fallsubstantially. On the other hand, additional costs will be incurred for theNDA filing, pre-launch activities and the recently announced developmentprogrammes. On balance, we expect cash used in operating activities in thesecond half of the year to remain around the level of the first half.
Dr Khalid Islam, President and CEO of Arpida, said: Progress in the year2007 to date has been tremendous. Our lead compound, intravenous iclaprim,has achieved the pre-specified primary endpoint in its second pivotal PhaseIII trial in cSSSI, confirming the result of the first. We have subsequentlyinitiated discussions with the FDA in order to prepare for the next step: thefiling of a New Drug Application for intravenous iclaprim in cSSSI.
With a view to a potential launch of intravenous iclaprim in 2008, we aresignificantly expanding our medical and scientific communications. A total of24 abstracts on iclaprim have been accepted at the upcoming ICAAC and IDSAconferences in the USA. We are eager to share our preclinical and clinicaldata with the medical and scientific community.
Dr Islam added: Progress was not limited to our most advanced programme,but was seen across the board. It included the authorisation from the US FDAto initiate Phase II trials with intravenous iclaprim in hospital-acquiredpneumonia, as well as steady progress in other programmes such as oraliclaprim, AR-709 and AR-2474. Looking at the disturbing increase and thebroadening of bacterial resistance against many of the current drugs, I feelthese antibiotic programmes are aimed at significant existing or emergingmedical needs.
Very recently, we succeeded in broadening our clinical pipeline furtherby acquiring the late-stage anti-fungal TLT therapy. TLT is about to enterPhase III clinical trials in Europe targeting onychomycosis an importantindication, affecting dozens of millions of people worldwide.
Dr Islam concluded: Overall I can say that Arpida remains on a steady,successful course, strengthening the foundations for a profitable future.
Results
In the first half of 2007, revenues of CHF 0.1 million were generated,related to contract research carried out for third parties.
Total operating expenses increased to CHF 33.7 million for the first sixmonths of 2007.Of these expenses CHF 2.7 million relate to IFRS 2 non-cashcharges for options accounting whereas this charge was CHF 1.0 million in thefirst half of 2006.
In the first half of 2007, 82% of the total operating expenses or CHF27.7 million (first half of 2006: CHF 23.9 million) was spent on research &development, a substantial part of which was related to the phase IIIclinical trial programme with intravenous iclaprim.
Management and general expenses were CHF 6.0 million in the first half of2007 (first half of 2006: CHF 4.6 million), thus remaining at a low levelrelative to the total operati
