Novo Nordisk A/S (NYSE: NVO) announces that it has received approval from the US Food and Drug Administration to market NovoSeven(r) Coagulation Factor VIIa (Recombinant). NovoSeven is a genetically engineered blood clotting protein 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. NovoSeven should be administered to patients only under the direct supervision of a physician experienced in the treatment of hemophilia.
"We are pleased to bring this life-saving product to market," said Bill Poole, president of Novo Nordisk Pharmaceuticals, Inc. "NovoSeven represents a major advance in the treatment possibilities available for these inhibitor patients. Because no human serum is used in production, there is no risk of human viral contamination, such as HIV or hepatitis," he added. "Moreover, hematologists who have participated in clinical trials with NovoSeven describe it as an effective, reliable agent for achieving hemostasis. NovoSeven has been successfully marketed in Europe for the last three years."
Hemophilia and NovoSeven
Hemophilia is a rare but serious disease. Patients spend their lives at risk of hemorrhage after even minor injury and can experience severe spontaneous bleeding episodes. They may bleed internally or externally and suffer great pain and long-term disability when the bleeding affects their joints or internal organs. Major trauma or surgery will almost inevitably lead to life-threatening hemorrhage.
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 and hence to clot formation at the site of injury.
NovoSeven is administered by intravenous bolus injection, and is dosed according to body weight.
Worldwide, approximately 50,000 hemophilia A and B patients are in treatment with blood factor products. Approximately 3,500 of these are inhibitor patients, one-half of whom live in the US.
Novo Nordisk A/S is the world leader in diabetes care and also manufactures and markets a variety of other pharmaceutical products. Furthermore, the company is the world's largest producer of industrial enzymes. Headquartered in Denmark, Novo Nordisk employs approximately 15,000 people in 61 countries and markets its products in 179 countries. Its B shares are listed on the stock exchanges in Copenhagen, London and Zurich. Its ADSs are listed on the New York Stock Exchange under the symbol "NVO." For further company information, visit Novo Nordisk on the World Wide Web at http://www.novo.dk
For further information please contact:
Media:
Erika Cosentino
Tel: (212)591-9816
Investors:
Peter Lundby Hansen
Tel: (212)867-0123
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