Maxygen achieved this latest milestone by developing a manufacturing process for the product candidates.
Factor VII is a natural protein with a pivotal role in blood coagulation and clotting. Currently, recombinant factor VIIa is approved in the US and Europe only for the treatment of hemophilia.
In December 2005, Maxygen and Roche established an agreement to co-develop and commercialize next-generation factor VIIa products for severe bleeding indications.
Under the terms of the agreement, Roche and Maxygen agreed to share worldwide R&D costs. Maxygen is leading early-stage clinical development, and Roche will lead late-stage clinical development.
Roche will have exclusive worldwide rights to commercialize the next-generation products for acute indications. Including an upfront fee, total event payments to Maxygen could total $95 million. In addition, Maxygen is also eligible to receive royalties on product sales.
Maxygen has retained all rights for development and commercialization of the product candidates for use in hemophilia.
“This milestone represents significant progress in our next-generation factor VIIa program,” said Russell Howard, CEO of Maxygen. “We view Roche as a leader in the development, manufacture and commercialization of biologics and we are pleased that they have accepted the manufacturing process developed by our project team.”