If today belongs to the age of information technology, then tomorrow would belong to biotechnology. Biotechnology is already making waves in food technology and medicine, and biotech products are expected to revolutionise the pharmaceutical industry. Essentially, biotechnology involves genetic engineering and DNA (deoxyribonucleic acid) technology, to produce new products or processes. An early breakthrough in medical biotechnology occurred about 20 years ago, with the discovery of a restriction enzyme that cut DNA strands into bits and another enzyme that joined the cut strips together. With these enzymes, DNA from two kinds of organisms could be spliced to form recombinant DNA. Organisms containing recombinant DNA could then be used to manufacture desired proteins.
The first drug to be produced through such genetic engineering was human insulin, which appeared on the market in 1982. By the 1990s, 500 different biological targets for drugs had been identified. With the help of the results of the Human Genome Project, another 500 could be identified in the next few years, and genetics is now being described as the biggest thing to hit drug research since Alexander Fleming’s discovery of penicillin.
Initially, biotechnology helped us to manufacture already known proteins, such as insulin for diabetes or erythropoietin for anaemia. Then came human proteins in human cells, not animal cells. For example, with transkaryotic therapy, erythropoietin can be produced in human cells instead of hamster cells, making the product almost identical to the erythropoietin produced by the human kidney. Among the most interesting categories of biotechnology products are the monoclonal antibodies, which being antibodies, are far more specific than conventional drugs. Monoclonal antibodies can be designed to bind to specific receptors, for example, on viruses (antivirals), or on cancer cells (anticancer drugs). Trastuzumab (Herceptin) is the first monoclonal antibody to slow metastatic breast cancer and acts by blocking HER2 receptors. Agents such as these will change the treatment of many diseases in the coming years.
The findings of the Human Genome Project, now nearing completion, will facilitate the discovery of new treatments. The genome, consisting of coiled threads of DNA and associated protein molecules organized into chromosomes, is found in the nucleus of the cell and represents the complete set of instructions for making an organism. Many diseases including heart disease, diabetes and cancer have a genetic aetiology and the identification of the relevant genes will lead to better prevention and treatment. Drug design will also be revolutionized because the process of drug discovery can follow a reasoned approach using genetic information, rather than the traditional trial-and-error method. These “designer drugs”, targeted at specific sites in the body, will have fewer side effects than many of today's medicines.
A promising application is gene therapy, based on the principle that if a disease is caused by a faulty gene, replacement with a ‘good’ one will control or prevent the disease. Gene therapy may involve somatic gene therapy (i.e., transfer to normal diploid cells), and germline gene therapy (transfer to haploid sperm or egg cells of the reproductive system). Somatic gene therapy involves manipulation of genes to correct a defect in a patient, but the benefit is not passed on to the next generation. With germline gene therapy, the development of inherited diseases could be prevented and eliminated in subsequent generations. Gene therapy could also be used as a drug delivery system. For example, during blood vessel surgery, a gene making an anticlotting factor could be inserted into the DNA of cells lining the blood vessels to prevent coagulation. With these and other such uses, gene therapy is set to redefine the practice of medicine in the years to come. It should be a powerful tool for treating many of the more than 4,000 known genetic disorders, as well as heart disease, cancer, arthritis, and diabetes mellitus. Its role is also being investigated in the preparation of vaccines, in organ transplantation and in many other situations.
In 1987, biotech companies had a combined value of just over $6 billion. By 1997, the figure was over $80 billion. Biotechnology stocks reached a peak in 1991, largely because of the success of two drugs, Epogen (erythropoietin) and Neupogen (Granulocyte Colony Stimulating Factor), both produced by one company, Amgen. Today, erythropoietin has sales of about $3 billion worldwide. Following Amgen's success, analysts began to have great expectations from biotechnology companies. However, because of high R&D expenditure, biotechnology companies are frequently cash strapped. The scope of usage of biotechnology products may also be limited by their high cost to the patient. Nevertheless, most of the large pharmaceutical companies are preparing for the future with a significant investment in biotechnology. Strategic alliances between biotechnology companies and regular pharmaceutical companies could also benefit both parties. With the biotech-related drugs market expected to be about $ 13 billion by the year 2003, pharmaceutical companies will undoubtedly benefit from defining their strategies with regard to these products.
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This article was published in Pharma Business 30th June 2000.
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