Isavuconazole (BAL4815) is a triazole antifungal. Its prodrug, isavuconazonium sulfate (BAL8557) is currently in two Phase IIIclinical trials (SECURE and VITAL), the results of which are expected in the second half of 2013.
On May 28, 2013, Basilea Pharmaceutica, the maker of the drug, announced it had been granted orphan drug status by the U.S. Food and Drug Administration (FDA).
Now Astellas Pharma Inc. (Tokyo:4503, "Astellas") announced today that the company has amended the License, Co-Development and Co-Promotion Agreement on isavuconazole under co-development with Basilea Pharmaceutica Ltd. ("Basilea"). Based on this amendment, the territories subject to the License Agreement have been changed to reflect that Astellas will be responsible for all regulatory filings and will exclusively commercialize and assume full responsibility for manufacturing isavuconazole in the U.S. and Canada.