Initiation of first isavuconazole study centers foreseen around year-end

Astellas and Basilea have obtained approvals from local authorities to allow restart of patient recruitment at first sites but have decided to use drug product from the commercial-scale production line, which covers the estimated demand for clinical trial material at all sites globally and allows for added buffer stock.

This decision will defer initiation of first sites to year-end or early 2011. This is expected to cause only minor delays in the initiation of the majority of sites because of the planned staggered global initiation of sites. The availability of phase III results continues to be expected in 2013.

About isavuconazole
Pre-clinical and clinical data generated to date indicate that isavuconazole has the potential to overcome many limitations of current therapies for the treatment of invasive fungal infections. Isavuconazole is given by intravenous infusion or oral capsules with high oral bioavailability that provides an option for intravenous-oral step-down. The drug has predictable and dose proportional pharmacokinetics that are important to ensure adequate therapeutic drug levels in patients with life-threatening fungal infections. The intravenous dose form has the potential to be given safely to patients with renal impairment.

The clinical program includes three international phase III trials with centers in the U.S., Europe and other regions that target respectively, yeast infections (candidemia/invasive Candida infections), mold infections (invasive aspergillosis) and finally rare molds and aspergillosis in renally impaired patients.

Earlier this year, an Independent Data Safety Monitoring Board recommended continuation of the phase III clinical trial of isavuconazole for the treatment of invasive Aspergillus infections based on a futility analysis of the first 180 patients.

Isavuconazole has been granted fast track designation by the U.S. Food and Drug Administration (FDA).

Contact
Adesh Kaul Head Public Relations & Corporate Communications T.: +41 61 606 1460 E.: media_relations@basilea.com