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.
Basilea assumes full rights to isavuconazole in the rest of the world in return for waiving its right to co-promote the product in the U.S. and Canada. The original agreement was executed in February 2010. Under the amended agreement, the submission of the New Drug Application (NDA) and potential approval in the U.S. will continue to be subject to the payment of a development milestone by Astellas. In addition, the conditions regarding sales milestone payments have been changed. Accordingly, the total amount of the development and sales milestones that Astellas is subject to paying Basilea is CHF 374 million.
Astellas will continue its collaborative relationship with Basilea on the development of isavuconazole to provide a new therapeutic option for the treatment of serious fungal infections to patients in the U.S. and Canada.