Maxygen, Roche to co-develop recombinant factor VIIa therapeutics for acute bleeding

By Ted A. Knutson

Washington, Dec. 15 - Maxygen, Inc. and Roche announced Thursday an alliance to co-develop recombinant factor VIIa products for multiple indications, including intracerebral hemorrhage (ICH) and trauma, which could mean up to $95 million for Maxygen.

Factor VII is a natural protein with a pivotal role in blood coagulation and clotting. Uncontrolled bleeding is the most common cause of trauma mortality in the hospital in the first 48 hours, with blood transfusion as the only treatment option. This partnership aims to offer patients a more effective, faster-acting treatment to stop critical bleeding.

Recombinant factor VIIa is approved in the United States and Europe for the treatment of hemophilia. Over the last 18 months, new clinical data has validated the use of recombinant factor VIIa-based products in the treatment of severe bleeding in trauma, surgery and ICH, officials said.

Analysts estimate that worldwide sales of all factor VIIa products could exceed $2 billion by 2010.

"This alliance is consistent with Maxygen's strategy of seeking to retain a large portion of the eventual value that may be created from our products while mitigating financial risk and leveraging the manufacturing, development and commercialization skills of leading protein pharmaceutical companies such as Roche," said Russell Howard, chief executive officer of Maxygen, in a press release.

Under the terms of the agreement, Roche and Maxygen will share worldwide research and development costs for the creation of next generation factor VIIa product candidates. Maxygen will lead early stage clinical development, and Roche will lead late stage clinical development with exclusive worldwide rights to commercialize the next generation recombinant factor VIIa molecules for acute indications.

In the United States, Maxygen has the option to co-fund marketing and in such case Maxygen would receive royalties in amounts comparable to profit sharing. Including an upfront fee, total event payments to the company could total $95 million, in addition to royalties. Maxygen has retained all rights for development and commercialization for next generation novel recombinant factor VIIa products for hemophilia.

Maxygen has headquarters in Redwood City, Calif., and is focused on the development of superior versions of validated major protein pharmaceuticals.

Basel, Switzerland-based Roche is one of the world's largest drug companies.

The announcement was made in an 8-K filing with the Securities and Exchange Commission.

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