Maxygen, Inc. has achieved a $5 million preclinical milestone in its alliance with Roche to co-develop next-generation factor VIIa therapeutics. Maxygen achieved the milestone for development of a manufacturing process for its factor VIIa product candidates.

In December 2005, Maxygen and Roche established an agreement to co-develop and commercialize next-generation factor VIIa products for multiple indications of severe bleeding, including trauma and intracerebral hemorrhage (ICH). Roche and Maxygen agreed to share worldwide R&D costs for the creation of next-generation factor VIIa product candidates. 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 recombinant factor VIIa products for acute indications. Including an upfront fee, total payments to Maxygen could total $95 million, in addition to royalties on product sales. Maxygen has retained all rights for development and commercialization of its next-generation recombinant factor VIIa product candidates for hemophilia.

“This milestone represents significant progress in our next-generation factor VIIa program,” said Russell Howard, chief executive officer 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. We are very excited about this program and the potential to develop improved factor VIIa products specifically tailored for acute bleeding indications.”