Recombinant Factor VIIa was first used in 1988 in connection with a knee operation in an inhibitor patient at the Karolinska Hospital in Stockholm, Sweden.

NovoSeven® for inhibitor patients has got a foot well in the door in the markets of Europe and is now being tested for possible use in the treatment of other diseases

NovoSeven®, Novo Nordisk's unique preparation for inhibitor patients, has got off to a flying start on the markets of Europe. In the first ten months after its introduction in February 1996, sales of NovoSeven® in the European markets amounted to DKK 150 million and in the first nine months of 1997 sales of NovoSeven® amounted to DKK 235 million. Novo Nordisk is now studying its potential in the treatment of other diseases.
NovoSeven® was developed for the treatment of a small group of haemophiliacs called inhibitor patients, who have developed antibodies against traditional haemophilia drugs. The estimated annual value of the world market for this type of medicine is approximately USD 200 million.

Unique preparation
NovoSeven® is a recombinant product - produced synthetically using gene technology. In contrast, all existing inhibitor drugs are based on blood plasma. NovoSeven® is a unique drug which has been developed from start to finish by Novo Nordisk. Its active substance, Factor VIIa, activates the inhibitor patient's defective blood clotting ability. NovoSeven® provides a well-tolerated and often shorter duration of treatment than other products in the case of bleeding episodes, which means more convenient treatment for the inhibitor patient and less load on the health care system in terms of hospitalisation and so on.

Good foothold in Europe
Novo Nordisk received EU approval to market NovoSeven® in February last year. Since then, the product has been launched on all the markets in the EU with the exception of Belgium, plus in Norway and Switzerland.
"Sales have gone even better than we expected," says Mads Valentin, international product manager in the NovoSeven® Strategic Marketing Group. He mentions particularly France and Germany as countries where a goal-oriented marketing campaign aimed at haemophilia experts has led to NovoSeven® quickly achieving prominent position in this very specialised niche of the pharmaceutical market.
"There is no doubt that recombinant Factor VIIa is a unique drug for the treatment of inhibitor patients, and our goal is clearly to become market leader in the field. The next major step is the important US market," says Valentin.

Long-term potential
While NovoSeven® is gaining more and more ground in the treatment of inhibitor patients, Novo Nordisk is well into studies to determine its efficacy in the treatment of other diseases or coagulation disorders. Preliminary clinical trials have shown that NovoSeven® can normalise coagulation time (so-called prothrombin time) in patients with liver disease. Phase 2 clinical trials have recently begun in such patients to further assess its potential in this group of patients. The estimated annual market value of this indication is approximately USD 600 million.
In the near future, Novo Nordisk will also embark on a study designed to assess the efficacy of NovoSeven® in patients who have normal blood coagulation, but who have suffered a subarachnoid haemorrhage, which is a form of central nervous system bleed.
"If the study turns out satisfactorily, NovoSeven® will have even greater long-term potential," says Valentin.

Scientific debate on the Internet
The position Novo Nordisk has attained in the haemophilia market with NovoSeven® has also put the company in the middle of a scientific debate on the subject. By providing an educational grant, Novo Nordisk has become the financial sponsor of an interactive homepage on the Internet, aimed at health care professionals. The website, called Haemophilia Forum, gives haemophilia specialists the opportunity to discuss and share experience with colleagues all over the world. An international editorial committee of more than 25 haemophilia experts is responsible for the scientific content of the website, which has exceeded expectations of popularity in a remarkably short time. The intention was to have 300 regular users in the first year, but after a good six months since the opening of the website in March, numbers are closer to 600.