New studies target new markets

Originally launched as a niche product for a rare type of haemophilia, NovoSeven® is now a candidate to become the world's first general haemostatic agent.

Technically, NovoSeven® is activated, recombinant coagulation Factor VII, expressed as rFVIIa. Novo Nordisk developed the product on the basis of the research of Professor Ulla Hedner. It was approved by the European authorities in March 1996, the US in 1999 and Japan in 2000 for the treatment of haemophilia patients who develop inhibitors (antibodies) to standard therapy.
Sales of NovoSeven® soared 63% to DKK 703 million in the first quarter of 2001 relative to the first quarter of 2000, and have grown by more than 40% every year since launch. Today the product represents approximately 14% of Novo Nordisk's sales. NovoSeven® is licensed in more than 50 countries, and the plan is to launch NovoSeven® globally. Thus the strategy is to target the estimated USD 350 million market potential of NovoSeven® for its current indication, enhancing its position as a first-line therapy in hospital and home treatment, in orthopaedic surgery and acquired haemophilia. Furthermore, in present markets Novo Nordisk is and will remain committed to the haemophilia community by promoting better treatment practices and developing NovoSeven®.
In the meantime, doctors and researchers have reported a number of investigational uses of the drug on patients with no underlying clotting disorders, such as during surgery and in connection with spontaneous or traumatic bleeding episodes. "Case stories indicate that NovoSeven® might have the potential for a number of uses other than the current indication but, of course, we need to conduct well-controlled clinical studies," explains Lars Nordholm, project vice president of the NovoSeven® Expansion Programme. "We hope to establish NovoSeven® as a general haemostatic agent and we are currently setting up studies addressing both safety and efficacy to determine the right dose levels in a number of clinical settings."

Universal agent
Novo Nordisk is committed to developing the substantial clinical documentation required for the use of NovoSeven® in clinical conditions calling for a general haemostatic agent. In setting up the expansion programme, Novo Nordisk took more than 40 therapeutic applications into consideration, covering the areas of coagulation factor deficiencies, blood platelet disorders and general haemostasis (the stopping of bleeding). Each indication was evaluated according to medical need, probability of success, market potential and competitive situation.
This evaluation has initially resulted in the selection of eight clinical trials, some of which have been initiated. The rest are planned to start before the end of the year. The status of the trials set-up is shown in the diagram, where yellow text indicates ongoing projects and orange text indicates which studies are expected to start before year-end. As mentioned Novo Nordisk is aware that NovoSeven® is currently being used investigationally in a number of areas, often when there is no other way to stop bleeding.
"The potential markets are big, and the use of a product like NovoSeven® to manage bleeding is cutting edge. Innovations in the treatment of haemorrhage have been scarce in recent decades. In addition, the competitive environment is unusual in that no other products like NovoSeven® exist. Thus competitors include various blood products and other therapies," says Nordholm. "NovoSeven® could help improve the outcome in operating rooms."
NovoSeven® is expected to make a difference for patients, physicians and payers alike. It is expected to help patients by giving them a higher chance of survival, fewer days in hospital and fewer blood transfusions. It is expected to help physicians by giving them better control of bleeding, fewer complications and less dependency on blood banks. Finally, it is expected to help healthcare payers by reducing intensive care unit (ICU) and ward days, reducing the need for blood transfusions and providing higher recovery rates.

	Haemophilia and NovoSeven® Haemophilia is a congenital bleeding disorder that imposes a heavy social and economic burden on the individual patient and on society. The prevalence of haemophilia in developed countries is approximately 1-2 per 10,000. Unless properly treated, haemorrhage into joints and muscles causes painful, progressive arthropathy and muscular atrophy. Without effective treatment, such haemorrhages result in severe disabilities. Inhibitors (antibodies) to Factor VIII and Factor IX emerge in 10-15% of haemophilia patients following coagulation factor replacement therapy, rendering further administration of the missing clotting factor ineffective. Acquired haemophilia is a condition in which previously normal individuals develop inhibitors. This is a rare and under-diagnosed disease. NovoSeven® selectively activates the platelets only at the injury site, where it creates high local thrombin formation that ensures a tight fibrin clot. Coagulation correction occurs within ten minutes and more than 150,000 administrations so far underpin the anticipated good safety profile. Additionally, as a recombinant product with no human plasma content, NovoSeven® eliminates the risk of contamination from viruses such as hepatitis or HIV.

	Why NovoSeven®? Area Why NovoSeven® in this area? Orthotopic liver transplantions*) NovoSeven® is expected to be able to reduce bleeding, leading to fewer transfusions and thereby reducing post-operative complications Liver resections*) NovoSeven® is expected to bring about fast induction of haemostasis and hopefully allow for transfusion-free surgery Upper gastrointestinal bleedings*) NovoSeven® is expected to bring about faster haemostasis and reduce re-bleeding episodes Liver resections in patients with no coagulation disorders NovoSeven® is expected to bring about fast induction of haemostasis and hopefully allow for transfusion-free surgery Intra-cerebral bleeings NovoSeven® is expected to bring about fast haemostasis and reduce mortality and morbidity, thus leading to increased quality of life Reversal of anticoagulation therapy (vitamin K-antagonists) NovoSeven® is expected to bring about faster haemostasis and reduce the number of transfusions, leading to faster recovery Stem cell/bone marrow transplantations NovoSeven® is expected to bring about faster haemostasis and reduce mortality and the number of transfusions. We also expect to have fewer patients with platelet antibodies Traumatology NovoSeven® is expected to bring about faster haemostasis and reduce mortality and the number of transfusions. Furthermore, we expect to see fewer multi-organ failures and thereby less surgery and faster recovery

*)Patients with cronic liver disease

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