Information for healthcare professionals only:
The number of people with hemophilia may be small.
But our effort to make their lives as natural as possible never ends.
Biovitrum’s range of products includes both factor VIII and IX concentrates.
Collaborations 2010
“Bleeding disorders” is the collective term for various diseases in which it is difficult for the blood to coagulate. From a treatment standpoint hemophilia is the most common type of bleeding disorder. Over the past ten years research in this field has made important advances, resulting in both more effective and safer treatment for patients. As knowledge of the disease has increased, we have also improved information to both patients and the healthcare system. Biovitrum has been extremely successful in the Nordic hemophilia market and we have increased our market share in this segment during the year through increased sales of ReFacto/ReFacto AF for the treatment of hemophilia A and by continuing sales of BeneFIX® for the treatment of hemophilia B. Biovitrum’s ventures involving future medications for hemophilia include agreements with Biogen Idec for the development of new protein pharmaceuticals to treat hemophilia A and B which are expected to facilitate patient treatment.
Doctors use heparin to prevent the blood from clotting, but in certain rare cases it can have the opposite effect and cause what is known as heparin-induced thrombocytopenia type II , or HIT. This serious complication is caused by an immunological reaction that leads to activation of platelets (thrombocytes) with blood clotting as a result and thereby also attendant risk for blood clots. Novastan® is a medication that effectively prevents blood clots in HIT.
Biovitrum is working with Symphogen to develop antibody based protein pharmaceuticals to treat two additional blood disorders: immune thrombocytopenia purpura (IT P) and Rh-immunization.
ReFacto AF® (moroctocog alfa) and Benefix® (nonacog alfa)
In hemophilia, the blood does not clot due to a deficit or complete lack of a coagulation factor. Therefore patients with hemophilia require injections of coagulation factor to stop and prevent frequent bleeding that often leads to permanent joint injury and possibly to life-threatening hemorrhage.
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 Biovitrum and our products for hemophilia include both factor VIII and IX concentrate.
Biovitrum originally developed the factor VIII concentrate ReFacto® when we were part of Pharmacia. In 1997 the medication was sold to Wyeth and marketed and sold in both Europe and the US. In June 2009 ReFacto AF was launched. ReFacto AF is a further development of ReFacto.
Coagulation factor eight, the active substance in ReFacto AF, is manufactured in Biovitrums plant in Stockholm.
Biovitrum markets ReFacto AF in the Nordic region through a collaboration agreement with Pfizer. ReFacto AF is a so called recombinant coagulation factor VIII concentrate used in patients with hemophilia A.
The new product ReFacto AF is a natural further development of ReFacto. The substance is the same as found in ReFacto, but Biovitrum manufactures it through an advanced production process, 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 also recently approved in the EU.
Results from Nordic study on ReFacto
Recently the results of the post-marketing safety surveillance study, which was performed by Biovitrum at almost all Nordic hemophilia clinics, were presented in an issue of Haemophilia.
All patients with severe or moderate hemophilia type A and who were treated with ReFacto at home by self-medication were asked whether they wanted to participate in this observational study, where the safety and efficacy of ReFacto were followed over 24 months. Read more about the study
Biovitrum also markets BeneFIX® in the Nordic region since 2007 under a collaborative agreement with Pfizer (formerly Wyeth). The active ingredient in BeneFIX is coagulation factor IX, developed with recombinant technology and produced without additives of either human or animal proteins. BeneFIX is used to treat acute hemorrhage and to prevent bleeding in patients with Hemophilia B. Hemophilia B is a bleeding disorder caused by congenital coagulation factor IX deficiency. BeneFIX is the only available recombinant factor IX product in the market.
All other treatment alternatives are based on purification of products from human blood.
Novastan® (argatroban)
Novastan is a reversible direct thrombin inhibitor indicated for anticoagulation in adult patients who have developed HIT type II. The onset of Novastan is rapid and the effect can be easily monitored using APTT. Novastan can be given also to patients with all degrees of impaired kidney function, without changing the initial dose. There is no cross reaction with HIT antibodies. Novastan is not immunogenic and the risk of anaphylaxis is low (1).
Biovitrum distributes Novastan in the Nordic region following an agreement with Mitsubishi Pharma Europe.
HIT - heparin induced thrombocytopenia type II - is an uncommon but severe complication in treatment with heparins (unfractionated as well as low molecular weight heparin). This condition is a thromboembolic complication, which ca be fatal. HIT is a result of an immunological reaction induced by heparins, leading to thrombocytopenia, activation of thrombocytes with clotting and a risk of arterial and/or venous thrombosis. The paradox is that the antithrombotic drug use suddenly increases the risk of thromboses and causes platelet-drop due to an immunologic mechanism.
When treatment with heparins goes wrong
HIT type II slide kit
Ref 1: Novastan® (argatroban) - summary of product characteristics
