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 US 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 US 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 US 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 CHF374m.
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 US and Canada.