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Orphan status in US for Astellas/ Basilea antifungal

Isavuconazole is being developed as a treatment for invasive aspergillosis

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The US FDA has given orphan drug status to isavuconazole, a broad-spectrum antifungal being developed by Astellas and partner Basilea Pharmaceuticals, as a treatment for invasive aspergillosis.

Isavuconazole has already been fast-tracked by the US regulator for aspergillosis, which tends to occur in transplant patients and those undergoing high-dose chemotherapy for leukaemia and has a mortality rate of between 34 and 58 per cent.

Astellas and Switzerland-based Basilea are carrying out two phase III trials of the antifungal which are due to generate results in the latter half of this year, setting up a possible approval in early 2014.

Analysts have suggested the drug could achieve peak sales of around $700m a year, helped by a growing market for antifungal drugs that is being driven by the widespread use of broad-spectrum antibiotics that deplete non-pathogenic bacterial levels in the body and allow fungi to gain a foothold.

Invasive aspergillosis is now the leading cause of death in bone marrow transplant patients. Astellas and Basilea are also developing isavuconazole for candidaemia/invasive candidiasis, the most common form of systemic fungal infection.

A pooled analysis of studies of the drug presented at a medical conference in April showed that isavuconazole was effective against a number of Candida strains that were resistant to treatment with fluconazole, which is recommended as a first-line treatment for candidiasis.

Astellas acquired worldwide rights to isavuconazole from Basilea in February 2010 in a deal valued at more than 550m Swiss francs ($500m).

For the Swiss company, orphan status for isavuconazole comes as a boost at a time when it is still struggling to bring its antibiotic product ceftobiprole to market and seeking a replacement for former market partner Johnson & Johnson, which handed back rights to the drug in 2011.

Basilea submitted an application in Europe to market ceftobiprole for the treatment of pneumonia last year and is in the process of answering queries from EU regulatory authorities. In the US, the FDA has asked for further analyses of the existing phase III data on the drug before it can complete its review.

29th May 2013

From: Sales



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