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news.Novo Nordisk and Neose Technologies have initiated a phase I clinical trial of GlycoPEGylated Factor VIIa, a long-acting version of NovoSeven Coagulation Factor VIIa (recombinant). The trial will assess the safety and pharmacokinetics of GlycoPEGylated Factor VIIa in healthy volunteers.
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GlycoPEGylated Factor VIIa is being developed by Novo Nordisk under a license agreement with Neose. The initiation of the phase I study triggers an undisclosed milestone payment to Neose under the license agreement.
“Novo Nordisk is committed to developing therapies to prevent or reduce bleeding episodes and to improve the quality of life in patients with hemophilia. We are pleased that our collaboration with Neose has resulted in a long-acting Factor VIIa clinical development candidate that has the potential to contribute to this goal,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk.
Factor VII/VIIa is used in the treatment of bleeding episodes and for the prevention of bleeding during surgery or invasive procedures in patients with congenital hemophilia with inhibitors to coagulation factors VIII or IX. The worldwide market for recombinant Factor VII was approximately $1 billion in 2006, with Novo Nordisk being the only participant.