Wyeth Pharmaceuticals, a division of Wyeth, announced that it has assumed all marketing and distribution rights to BeneFIX Coagulation Factor IX (Recombinant) in Europe.
This transfer of responsibility follows the planned June 30, 2007 conclusion of a 10-year distribution rights agreement between Baxter Healthcare Corporation and Genetics Institute. Genetics Institute was acquired by Wyeth in 1996. Representatives of Wyeth and Baxter have worked closely together to ensure a structured transition between companies and an uninterrupted supply of BeneFIX to people with haemophilia B.
"We are pleased to broaden Wyeth's range of therapeutic offerings for the haemophilia community in Europe. We also have plans-pending European regulatory approval-to introduce new convenience enhancements to BeneFIX later this year," says Cavan Redmond, executive vice president & general manager, BioPharma Business Unit at Wyeth Pharmaceuticals.
Wyeth now manufactures and markets recombinant products for both haemophilia A and B in Europe, which are rare bleeding disorders.
In May 2007, Wyeth Pharmaceuticals received a positive opinion from the Committee for Medicinal Products for Human Use, the scientific committee of the European Medicines Agency, on new convenience enhancements to BeneFIX. The product enhancements are: a 2000 IU dosage strength vial, a needleless reconstitution device, a prefilled diluent syringe and a low 5 mL diluent volume for all dosage strengths.
Haemophilia B is a rare, inherited blood clotting disorder. People with haemophilia B are deficient in a key protein- factor IX- which is vital in the clotting mechanism to prevent bleeding. Haemophilia B is characterized by spontaneous haemorrhages or prolonged bleeding, typically into joints and soft tissue. Patients with haemophilia B are dependent on protein replacement therapy with factor IX.
BeneFIX is indicated for the control and prevention of hemorrhagic episodes in patients with haemophilia B (congenital factor IX deficiency or Christmas disease), including control and prevention of bleeding in surgical settings.
BeneFIX is not indicated for the treatment of other factor deficiencies (e.g., factors II, VII, VIII and X) nor the treatment of haemophilia A patients with inhibitors to factor VIII, nor the reversal of coumarin-induced anticoagulation, nor the treatment of bleeding due to low levels of liver-dependent coagulation factors.
ReFacto Antihemophilic Factor (Recombinant) is indicated for the control and prevention of haemorrhagic episodes and for surgical prophylaxis and for short-term routine prophylaxis to reduce the frequency of spontaneous bleeding episodes in patients with haemophilia A. The effect of regular routine prophylaxis on long-term morbidity and mortality is unknown.