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NN7128

Novo Nordisk A/S

Drug Names(s): long-acting NovoSeven, long-acting rFVIIa derivative, rFVIIa glycopegylated, N7-GP

Description: GlycoPEGylated Factor VIIa is a long-acting version of NovoSeven Coagulation Factor VIIa (Recombinant). NovoSeven is a genetically engineered blood clotting protein, factor VII, that plays an important role in the sequence of events that normally leads to the formation of a clot in an injured blood vessel. NovoSeven is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors (antibodies) to coagulation Factors VIII or IX. The most important substrates of activated fact VII are coagulation factors IX and X.

Hemophilia is characterised by the insufficiency of Factor VIII or IX, proteins that are responsible for the formation of hemostatic plugs that control hemorrhage. Bleeding episodes in hemophilia patients are usually treated by intravenous administration of blood clotting Factors VIII or IX. However, approximately 10% of hemophilia A or B patients develop antibodies to Factor VIII or IX, often rendering this treatment ineffective.

NovoSeven overcomes this problem by enabling clotting through a unique mechanism of action that induces hemostasis independently of Factor VIII or IX. NovoSeven binds to tissue factor, a protein expressed in the damaged vessel wall, and this complex leads to activation of the coagulation system through factors IX and X, and hence to clot formation at the site of injury.

Deal Structure: In November 2003, Neose Technologies entered into two research, development and license agreements with Novo Nordisk to use Neose's GlycoPEGylation technology to develop three next-generationproteins within Novo Nordisk's therapeutic areas (including GlycoPEGylated Factor VIIa). Under the terms of the agreements, Neose will receive a $4.3 million upfront fee and up to $51.3 million in milestone payments based on theprogress of the programs. Novo Nordisk is responsible for funding Neose's research and development activities under the agreements, and Neose will receive royalties on sales of any products commercialized under the agreements. In addition, Neose could receive additional milestones and royalties on new indications for the two proteins not currently marketed byNovo Nordisk.

In September 2008, Neose announced that it signed definitive asset purchase agreements with Novo Nordisk and BioGeneriX providing for the sale of substantially all of the assets of Neose in all-cash...See full deal structure in Biomedtracker


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