Next-generation Factor VIIa for treatment of hemophilia

Maxygen is developing an improved Factor VIIa for the treatment of hemophilia and, potentially, acute bleeding conditions such as occur in trauma injury. Hemophilia is an serious medical condition that causes frequent bleeding episodes due to the absence of a particular blood clotting factor. The majority of hemophilia patients are known to have an absence of Factor VIII (known as Hemophilia A), while others are known to be deficient in Factor IX (Hemophilia B). The primary treatment for hemophilia is replacement of FVIII and FIX clotting factor in Hemophilia A and B patients, respectively.

Over time, some hemophilia patients develop immunity to these replacement clotting factors and must be treated with an agent that bypasses the intrinsic human coagulation cascade. The majority of patients with immunity to Factor VIII or Factor IX are treated with a recombinant Factor VIIa therapy. 

Market Opportunity
At present, NovoSeven® is the only recombinant Factor VIIa product  approved for treatment of hemophilia patients with immunity to FVIII or FIX. Treatment with NovoSeven® can be expensive and cumbersome, with patients receiving multiple doses per bleeding episode until clotting is achieved. Sales of NovoSeven® in 2006 were approximately $980 million. Maxygen believes that a next-generation recombinant Factor VIIa drug with improved efficacy and pharmacokinetic properties could offer benefits such as increased duration of effect or less frequent dosing.

MAXY-VII has been shown to be more efficacious than NovoSeven® in preclinical animal bleeding models. Ex-vivo studies using human blood have shown similar results.

Development Status
Maxygen plans to initiate clinical trials of MAXY-VII in 2008. We currently retain all rights to our MAXY-VII product candidates.

 View ISTH 2007 Presentation on the MAXY-VII program

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