Perspective - May 1998
Novo Nordisk's first Type 2 product
Launch of Prandin™/NovoNorm®
Financial highlights
Summary of the Group
Financial statement
For the first quarter of 1998
Disease management - the Novo Nordisk way
A new concept in health care
NovoNet™ - the Irish example
The cornerstone of Novo Nordisk's disease management programme
The euro and its consequenses
Pricing and currency exposure are two aspects of the euro issue. The coming of the euro is an opportunity and a challenge

 

Drug development
A new strategy
Novo Nordisk
New strategy behind drug development

ZymoGenetics is among the leaders in the race to unravel the functions of human genes.

The classical approach to medical research is to first find a therapeutic area then to initiate the search for active substances.
At ZymoGenetics - Novo Nordisk's US Health Care discovery centre in Seattle - they have taken a different approach. Here the aim is to determine the function of human genes whose identification is currently progressing so fast. In simple terms, certain genes code for certain proteins. And certain proteins can be used as drugs. So unlike the classical approach to medical research, you only identify what therapeutic areas a drug may be useful in once you have discovered the function of a particular gene.
The ZymoGenetics approach functions as a supplement to the more traditional methods that are still vital to the continued development of new products and therapies at Novo Nordisk's research centres both in Denmark and in other countries.
"The human genome will be identified within four or five years. So we have turned our research strategy completely around and are concentrating on finding the function of those genes that have been identified," says Claus Kühl, president of ZymoGenetics.
ZymoGenetics receives a continuous stream of data from Incyte Pharmaceuticals, Sequana and Lark, companies specialising in collecting, selling or generating genetic data. ZymoGenetics is one of the relatively few companies in the world with access to these data.
Identifying genes is progressing much more rapidly than discovering their ultimate biological or therapeutic functions. Even though every human gene will be identified within a short span of years, it may take ten years before scientists have discovered precisely what they do.
"The competition is fierce, but we are among the leading companies in the world doing just that. Simply because we adopted this strategy at a very early stage and because our research team has put together the right combination of scientific disciplines, including molecular biologists, bioinformaticians, biochemists, and biologists," says Kühl.
ZymoGenetics' research strategy means that they conduct research that can lead to the discovery of new drugs that lie outside Novo Nordisk's three core areas in Health Care - Diabetes Care, Women's Health Care and Growth Disorders.
"If we come across genes or proteins that can be used in the treatment of cancer, for example, we can either develop and market the drugs ourselves or swap our findings with another pharmaceutical company that may have found a gene that could be of vital importance to the treatment of diabetes," explains Kühl.

Claus Kühl
Claus Kühl: The identification of the human genome is going to be an important tool in the development of new medicines.
From genes to medicine
It is estimated that the human genome consists of between 100,000 to 120,000 genes, controlling every biological function from the structure of a cell to the body's production of hormones. Of these tens of thousands of genes, there are perhaps only a few hundred that are involved in biological control mechanisms and which would be of medical importance. But knowledge of the functions of these few hundred will potentially revolutionise all medical treatment as we know it today.
The reason the identification process is going so fast is that researchers discovered some years ago that it was not necessary to map the entire collection of human DNA from one end to the other to locate the genes.
Once the sequence of a small portion of a gene is known, that short sequence is often enough to identify the entire gene and reveal where it came from in the human genome. The quantities of data are enormous. So based on prior knowledge of gene sequences and their functions, you can make computer simulations of how the individual genetic product can be expected to look and behave. Those genes that look promising are described and presented to a scientific evaluation group that takes the decision of whether the gene sequence is worthy of further laboratory examination. Here the gene is cloned along its full length, after which it is introduced into a microorganism or cell, which, as a result, starts producing the protein the gene codes for. The protein is purified and its function analysed by various biological tests. If its function is important, a patent application will be filed to stay ahead of the competition.

Patents essential
Medicines based on proteins generally have much better patent protection and thus exclusivity in the market. In contrast, medicines based on small molecules have experienced increasing and very fierce competition because effective patent protection is far more difficult to achieve.

Exclusivity is becoming shorter
Drug Use First
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Years of exclusivity
Inderal®
Tagamet®
Capoten®
Seldane®
Retrovir®
Mevacor®
Prozac®
Cozaar®
Risperdal®
Diflucan®
Zofran®
Invirase®
Angina®
Antiulcer
Antihypertensive
Allergies
AIDS
Elevated lipids
Antidepressant
Antihypertensive
Antipsychotic
Antifungal
Antinausea
AIDS
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Patent protection of new pharmaceutical products is becoming shorter and shorter. As a consequence, the ability to launch new products faster becomes increasingly important in the years to come.

A patent is essential for further development of a therapeutic agent. Without a patent, it makes no commercial sense to invest in clinical trials and all the procedures necessary to get a new drug approved. Costs for development and testing of a new drug typically run into several billion DKK and if this investment is not protected by a patent, keeping competing companies out for a certain period of time, it would be impossible ever to recover the costs of developing a new drug.
You can obtain a patent covering an isolated gene or a protein, as well as a pharmaceutical product to treat or prevent diseases or conditions.

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