The most common forms of hemophilia are called A and B dependent on which coagulation factor the patient is lacking. In hemophilia A there is a shortage of factor VIII and in hemophilia B there is a shortage of factor IX. Hemophilia A is the most common. Only one in five hemophiliacs has the B form. It is a genetic disease which with few exceptions mainly afflicts males. In the Nordic countries, about 2,000 men (and a few women) currently suffer from this disease.
Hemophilia is a high priority area at Sobi and our products for hemophilia include both factor VIII and IX concentrates. We originally developed the factor VIII concentrate ReFacto when we were part of Pharmacia. Today, we produce ReFacto to meet global needs for Pfizer. ReFacto is a recombinant coagulation factor VIII concentrate used in patients with Hemophilia A. In 1997 the medication was sold to Wyeth (now Pfizer) and marketed and sold in both Europe and the US.
The pharmaceutical substance in ReFacto AF is the same as found in ReFacto, but Sobi manufactures it through an advanced production process completely free of any human or animal components. The process is therefore cleaner with respect to foreign proteins, which both doctors and patients perceive to be a major safety advantage.
ReFacto AF is approved for sale in the United States and Canada under the Xyntha brand name and was recently approved in the EU.
