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New NovoSeven® indication holds promise for growth Since its launch way back in 1996, NovoSeven® has been a so-called niche product, needed by very few patients worldwide. A new indication, which is now in Phase 3 clinical development, suggests that NovoSeven® might become a big product. |
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Award for Annual Report For the fourth time Novo Nordisk has received the Danish Society of Financial Analysts' Information Award. |
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Financial highlights Summary of the Group |
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Financial
statement For the first nine months of 1999. |
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Enzymes solve industrial problems Enzymes are environmentally friendly in production, application and disposal. They can, therefore, in many instances be applied in industries wanting a sustainable development. |
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New vision sharpens On occasion of its establishment as an independent company Novo Nordisk A/S (pharmaceuticals) has adopted a new strategy and vision. Main elements are a strong focus on diabetes and customer value. |
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New NovoSeven® indication holds promise for growth
Since its launch way back in 1996, NovoSeven® has been a so-called niche product, needed by very few patients worldwide. A new indication, which is now in Phase 3 clinical development, suggests that NovoSeven® might become a big product.
NovoSeven® has shown impressive rates of growth in previous years. Thanks to introductions on new markets and a heavy rise in demand on existing markets, sales increases have been on the right side of 40% year after year. In 1999 alone, sales more than doubled from DKK 576 million in 1998 to DKK 1.3 billion in 1999.The launch in the US in April 1999 contributed significantly to these impressive results.
Up to now NovoSeven® has only been approved for treating haemophilia patients who were unable to be treated with other preparations due to a so-called antibody (or inhibitor) reaction that makes those treatments ineffective. However, there are many more people who lack one or more coagulation factor, which means that they cannot stop bleeding - or can only stop with great difficulty. One large patient group is what we call liver patients - that is people whose livers don't function optimally.
In the Western world alone it is estimated that there are 1.7 million people with coagulation disorders due to liver disease - or a far larger patient group than inhibitor patients, which only comprise about 5,000 people worldwide.
Added to that are 8 to 10 million annual cases of serious acute bleeding episodes in the US, EU and Japan alone, of which a number could probably be helped by NovoSeven® treatment.
The potential market for NovoSeven® can be categorised into three segments according to cause of bleeding: lack of coagulation factors, blood-platelet disorders and general haemostasis (stopping of bleeding). In other words, this could be a substantial market in the long term. If the authorities approve the various indications, NovoSeven® could be one of the absolutely most vital pharmaceuticals for treating life-threatening bleeding disorders.
Great potential lives up to the vision
NovoSeven® is a product that can help save lives. Exactly as with haemophilia patients, there isn't really an effective treatment form for all those millions of people other than NovoSeven®. The use of NovoSeven® in connection with operations on liver patients and later perhaps for treating any form of serious bleeding will help cut down on days spent in hospital and thus reduce costs.
Ambitious Phase 3 studies
Preliminary clinical experience with NovoSeven® in conjunction with surgical procedures is very positive. Novo Nordisk has carried out a pilot study in which six patients received liver transplants and NovoSeven® was used to reduce bleeding and thus the need for blood transfusions. Experience from this study shows that the need for blood transfusion can be reduced significantly compared to traditional treatment. If these positive results are confirmed in the impending Phase 3 studies, then things really look promising.
The Phase 3 studies to be started will comprise two studies with a total of 160 patients, all of whom are scheduled for liver transplants. The first study will be conducted in Finland, Germany, Spain, Holland and the US, with the participation of the four largest centres in the world. The same protocol (research description) will be used everywhere, which is unusual because the requirements from the authorities and participating hospitals are often different on each side of the Atlantic Ocean.
The job of finding suitable patients for the studies is in the hands of the clinical departments taking part in the studies, but Novo Nordisk will manage the entire process.
A new market
There haven't been any new products for treating serious bleeding episodes for the past 30 years. NovoSeven® is the first. Even though this puts Novo Nordisk in a unique situation, introducing the product is still a difficult prospect, because this is a new area of therapy in which Novo Nordisk is not known ahead of time. However, specialist hospital departments, which are few and far between in the various countries, will be handling treatment and thus making our job easier. Experience from the countries that have already launched NovoSeven® shows that when the individual affiliates allocate the resources needed for the job, it doesn't take long before they can see the results.
Studies cover a broad spectrum
Together, the Phase 3 studies will comprise patients who need minor, medium and major surgery. In addition to the Phase 3 studies described here, in the course of 2000 a number of Phase3B studies will be initiated in order to show that NovoSeven® can stop bleeding during various types of surgery involving liver patients.
Whereas having a tooth pulled and having a liver transplant are at either ends of the spectrum, there are many surgeries in between. In order to show that NovoSeven® is a good, reliable and effective choice for these types of surgery as well, broader studies are being conducted prior to filing for registration. A total of 1,000 patients will be participating in the clinical trials.
