How biotechnology is used

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We Innovate Healthcare Biotechnology - new directions in medicine Roche Biotechnology – new directions in medicine Biotechnology – new directions in medicineCover picture The Roche Group, including Genentech in the United States and Chugai in Japan, is a world leader in biotechnology, with biotech production facilities around the globe. The cover photo shows a bioreactor at Roche’s Penzberg facility and conveys at least a rough of idea of the sophisticated technical know-how and years of experience required to manufacture biopharma- ceuticals. Published by F. Hoffmann-La Roche Ltd Corporate Communications CH-4070 Basel, Switzerland © 2008 Third edition Any part of this work may be reproduced, but the source should be cited in full. All trademarks mentioned enjoy legal protection. This brochure is published in German (original language) and English. Reported from: Mathias Brüggemeier English translation: David Playfair Layout: Atelier Urs & Thomas Dillier, Basel Printers: Gremper AG, Basel 7 000 728-2Content Foreword Progress via knowledge 5 Beer for Babylon 7 Drugs from the fermenter 25 Main avenues of research 39 Treatment begins with diagnosis 51Progress via knowledge Over the past few decades biotechnology – sometimes described as the oldest profession in the world – has evolved into a mod- ern technology without which medical progress would be scarcely imaginable. Modern biotechnology plays a crucial role both in the elucidation of the molecular causes of disease and in the development of new diagnostic methods and better target- ed drugs. These developments have led to the birth of a new economic sec- tor, the biotech industry, associated mostly with small start-up companies. For their part, the more established healthcare com- panies have also been employing these modern techniques, known collectively as biotechnology, successfully for many years. By studying the molecular foundations of diseases they have developed more specific ways of combating diseases than ever before. This new knowledge permits novel approaches to treatment, with new classes of drug – biopharmaceuticals – at- tacking previously unknown targets. Increasing attention is also being paid to differences between individual patients, with the result that in the case of many diseases the goal of knowing in advance whether and how a particular treatment will work in a given patient is now within reach. For some patients this dream has already become reality. Diagnosis and treatment are thus becoming increasingly inter- twined. When a disease, rather than being diagnosed on the ba- sis of more or less vague signs and symptoms, can be detected on the basis of molecular information, the possibility of suc- cessful treatment depends largely on what diagnostic techniques are available. To the healthcare industry this represents a major development in that diagnosis and treatment are growing ever closer together, with clear benefits for companies that possess competence in both these areas. To patients, progress in medical biotechnology means one thing above all: more specific, safer and more successful treatment of their illnesses. To the health- care industry it represents both an opportunity and a challenge. For example, more than 40% of the sales of Roche’s ten best-sell- ing pharmaceutical products are currently accounted for by bio- pharmaceuticals, and this figure is rising. This booklet is intended to show what has already been achieved via close cooperation between basic biological research, applied science and biotechnologically based pharmaceutical and diag- nostic development. 5Beer for Babylon For thousands of years human beings have used microorganisms to make products – and in so doing have practised biotechnology. Just as in the past the development of beer, bread and cheese were major breakthroughs, another revolution is now about to overtake medicine: compounds produced using biotechnological methods are opening up entirely new possibilities in medical diagnostics and therapy, and in so doing are bringing about a major restructuring of markets.5000–2000 BC 500 BC Fermentation processes are used in The antibiotic effect of tofu mould Egypt, Babylon and China to make cultures is discovered and used for bread, wine and beer. Wall painting therapeutic purposes in China. from an Egyptian tomb built during the Fifth Dynasty (c. 2400 BC). From knowledge to science: the history of biotechnology Babylonian biotechnologists were a highly regarded lot. Their products were in demand among kings and slaves and were ex- ported as far as Egypt. They are even mentioned in the Epic of Gilgamesh, the world’s oldest literary work – the Babylonian brewers, with their 20 different types of beer. Their knowledge was based on a biological technology that was already thousands of years old – fermentation Terms by yeast. Though it may sound Biopharmaceuticals drugs manufactured using biotech- nological methods. strange, the brewing of beer DNA deoxyribonucleic acid; the chemical substance that is an example of biotechnol- makes up our genetic material. Genes functional segments of our genetic material that serve ogy. Likewise, so is the bak- mostly as blueprints for the synthesis of proteins. ing of bread. Wine, yogurt, Genome the totality of the DNA of an organism. cheese, sauerkraut and vine- Gene technology scientific work with and on the genetic material DNA. gar are all biotechnological Recombinant proteins proteins obtained by recombining products. Biotechnology is DNA, e.g. by introducing human genes into bacterial cells. practised wherever biologi- cal processes are used to produce something, whether Babylo- nian beers or monoclonal antibodies. The only thing that is relatively new about the biotechnology industry is its name. Stone Age, Iron Age, The term ‘biotechnology’ was first used in a 1919 Age of Biochemistry publication by Karl Ereky, a Hungarian engineer and economist. He foresaw an age of biochemis- try that would be comparable to the Stone Age and the Iron Age in terms of its historical significance. For him, science was part of an all-embracing economic theory: in combination with po- litical measures such as land reform, the new techniques would provide adequate food for the rapidly growing world population – an approach that is just as relevant today as it was in the pe- riod after the First World War. 8AD 100 800–1400 1595 Ground chrysanthemum seeds are Artificial insemination and fertilisation Hans Janssen, a spectacle maker, used as an insecticide in China. techniques for animals and plants builds the first microscope. improve reproduction rates and yields in the Middle East, Europe and China. © Rijksmuseum van Oudheden, Leiden, The Netherlands Ereky’s vision is all the more astonishing given that at that time the most important tools of modern biotechnology were yet to be discovered. Until well into the second half of the 20th century biologists worked in essentially the same way as their Babylo- Beer for Babylon 91665 C. 1830 C. 1850 Examining a thin slice of cork under The chemical nature of proteins is The cell is identified as the smallest the microscope, Robert Hooke discov- discovered and enzymes are isolated. independent unit of life. ers rectangular structures which he names ‘cells’. Two years later Antoni van Leeuwenhoek becomes the first person to see bacterial cells. nian predecessors: They used the natural processes that occur in cells and extracts of plants, animals and microorganisms to pro- duce the greatest possible yield of a given product by carefully controlling reaction conditions. Thanks to newly developed methods, however, the biotechnol- ogy of the 20th century was able to produce a far greater range of such natural products and at far higher levels of purity and quality. This was due to a series of discoveries that permit- ted the increasingly rapid development of new scientific tech- niques: z In the first half of the 19th century scientists discovered the basic chemical properties of proteins and isolated the first enzymes. Over the following decades the role of these sub- stances as biological catalysts was elucidated and exploited for research and development. z The development of ever more sophisticated microscopes rendered the form and contents of cells visible and showed the importance of cells as the smallest units of life on Earth. Louis Pasteur postulated the existence of microorganisms and believed them to be responsible for most of the fermen- tation processes that had been known for thousands of years. This was the birth of microbiology as a science. z From 1859 Charles Darwin’s theory of evolution revolution- ised biology and set in train a social movement that led ul- timately to a new perception of mankind. For the first time the common features of and differences between the Earth’s organisms could be explained in biological terms. As a result, biology changed from a descriptive to a more experimental scientific discipline. z The rediscovery of the works of Gregor Mendel at the end of the 19th century ushered in the age of classical genetics. Knowledge of the mechanisms of inheritance permitted targeted interventions. Cultivation and breeding techniques that had been used for thousands of years now had a scien- tific foundation and could be further developed. 101859 1866 1869 Charles Darwin publishes his The Augustinian monk Gregor Mendel Friedrich Miescher, working in revolutionary theory of evolution. discovers the rules governing the Tübingen, isolates a substance from inheritance of traits in peas. It will be white blood cells in purulent 35 years before his work receives the bandages that he refers to as ‘nuclein’. recognition it deserves and lays the His description leads later to use foundations of modern genetics. of the term ‘nucleic acids’. These developments changed the face of biochemistry and bio- technology. In addition to the classical, mostly agricultural, products, more and more new products entered the market- place. Enzymes were isolated in highly purified form and made available for a wide variety of tasks, from producing washing powder to measuring blood glucose. Standardised biochemical test methods made their entrance into medical diagnostics and for the first time provided physicians with molecular measuring instruments. The structures and actions of many biomolecules were elucidated and the biochemical foundations of life thereby made more transparent. Biochemistry progressed from basic re- search to a field of development. Gene technology spurs However, it was only with the advent of gene tech- innovation nology that biology and biotechnology really took off. From 1953, when James Watson and Francis Crick presented the double helix model of DNA, work on and with human genetic material took on the attributes of a scientific race. As more was discovered about the structure of DNA and the mechanisms of its action, replication and repair, more ways of intervening in these processes presented them- selves to researchers. Desired changes in the genetic makeup of a species that previously would have required decades of system- atic breeding and selection could now be induced within a few months. For example, newly developed techniques made it possible to in- sert foreign genes into an organism. This opened up the revolu- tionary possibility of industrial-scale production of medically important biomolecules of whatever origin from bacterial cells. The first medicine to be produced in this way was the hormone insulin: in the late 1970s Genentech, an American company, de- veloped a technique for producing human insulin in bacterial cells and licensed the technique to the pharmaceutical company Eli Lilly. Hundreds of millions of diabetics worldwide have ben- Beer for Babylon 111878 1879 1913 While searching for the organism Walther Fleming describes the In studies on the fruit fly Drosophila responsible for anthrax, Robert Koch ‘chromatin’ present in cell nuclei; this melanogaster, Thomas Hunt Morgan develops techniques for the cultivation will later be identified as DNA. discovers more rules of inheritance. of bacteria that are still used today. Gene technology: human insulin from bacteria In 1982 human insulin became the world’s first biotechnolog- In 1978 the biotech company Genentech developed a method ically manufactured medicine. This hormone plays a central of producing human insulin in bacterial cells. Small rings of role in glucose metabolism in the body. In diabetics the body DNA (plasmids), each containing part of the gene for the either has lost the ability to produce insulin in sufficient quan- human hormone, were inserted into strains of Escherichia coli. tity (type 1 diabetes) or else no longer responds adequately The bacteria then produced one or the other of the two insu- to the hormone (type 2 diabetes). All people with type 1 dia- lin chains. These were then separately isolated, combined and betes and most people with type 2 diabetes require regular finally converted enzymatically into active insulin. The pharma- doses of exogenous insulin. ceutical company Eli Lilly acquired an exclusive licence for this Until 1982 insulin was isolated from the pancreas of method from Genentech and introduced the medicine in 1982 slaughtered animals via a complex and expensive process – in the USA and later worldwide – thus firing the starting gun up to 100 pig pancreases being required per diabetic patient for medical biotechnology. per year. In its day, this classical biotechnological method it- Some 200 million diabetics worldwide now benefit from the self represented a major medical breakthrough: until 1922, production of human insulin. Without gene technology and when medical scientists discovered the effect of pancreatic biotechnology this would be impossible: in order to meet cur- extracts, a diagnosis of type 1 diabetes was tantamount to a rent demands using pancreatic extract, around 20 billion pigs death sentence. The hormone obtained from cattle and pigs would have to be slaughtered annually. differs little from the human hormone. However, some patients treated with it develop dangerous allergic reactions. 121919 1922 1928 Karl Ereky, a Hungarian engineer, Frederick Banting, Charles Best Alexander Fleming discovers the coins the term ‘biotechnology’. and James Collip observe the antibiotic effect of penicillin. beneficial effect of a pancreatic extract on diabetes; the hormone insulin is discovered. efited from this, the first biotechnologically manufactured med- icine, since its introduction in 1982 (see box, p. 12). A new economic This technology laid the foundation for a new in- sector arises dustry. The early start-up biotech companies joined forces with large, established pharmaceu- tical companies; these in turn used biotechnology to develop high-molecular-weight medicines. Rapid expansion In the early 1980s very few companies recognised and stock market boom the medical potential of the rapidly expanding field of biotechnology. One such visionary com- pany was Genentech. This company, which can lay claim to being a founder of the modern biotech industry, was formed in 1976 by Herbert Boyer, a scientist, and Robert Swanson, an en- trepreneur, at a time when biochemistry was still firmly ground- ed in basic research. However, Genentech did not remain alone for long. From the late 1970s, and even more after the introduc- tion of recombinant human insulin, more and more companies that aimed to exploit the scientific success of gene technology for the purposes of medical research and development were formed, especially in the USA. Even today, nine of the ten biggest companies devoted purely to biotechnology are based in the USA (see box, p. 16). At first these young companies worked in the shadow of the pharmaceutical giants. This was true both in relation to sales and number of companies and also in relation to public profile. The situation changed abruptly, however, when biotech prod- ucts achieved their first commercial successes. In the 1990s pro- gress in gene technological and biotechnological research and development led to a veritable boom in the biotech sector. Within a few years thousands of new biotech companies sprang up all over the world. Many of these were offshoots of public or Beer for Babylon 131944 1953 From 1961 Oswald Avery, Colin MacLeod and On the basis of Rosalind Franklin’s Various researchers unravel the Maclyn McCarthy identify DNA x-ray crystallographic analyses, James genetic code. as the chemical bearer of genetic Watson and Francis Crick publish a information. model of the genetic substance DNA. private research institutes whose scientists hoped to obtain financial benefit from their findings. Fuelled by expectations of enormous future profits, the burgeoning biotechnology indus- try became, together with information technology, one of the driving forces behind the stock market boom of the final years of the 20th century. Measured on the basis of their stock market value alone, many young biotech companies with a couple of dozen em- ployees were worth more at that time than some estab- lished drug companies with annual sales running into hundred of millions of dollars. While this ‘investor exuberance’ was no doubt excessive, it was also essen- tial for most of the start-ups that benefited from it. For the development of a new This life-size bronze sculpture of Genentech’s founders is on display at the company’s research centre in South drug up to the regulatory San Francisco. approval stage is not only extremely lengthy, but also risky and hugely expensive. The main reason for this is the high proportion of failures: only one in every 100,000 to 200,000 chemically synthesised molecules makes it all the way from the test tube to the pharmacy. Biotechnological production permits the manufacture of com- plex molecules that have a better chance of making it to the mar- ket. On the other hand, biotechnological production of drugs is more technically demanding and consequently more expensive than simple chemical synthesis. Without the money generated by this stock market success, scarcely any young biotech com- pany could have shouldered these financial risks. For this reason many smaller biotech companies – just like Gen- entech in 1982 – are dependent on alliances with major drug 141973 1975 1976 Stanley Cohen and Herbert Boyer Georges Köhler and César Milstein Herbert Boyer and Robert Swanson use restriction enzymes and ligases to publish their method for the found Genentech, the first modern recombine DNA. production of monoclonal antibodies. biotechnology company. The first modern biotechnology company: Genentech It took courage to found a biotechnology company in 1976. biologist Herbert Boyer had intended to grant the young At that time the business world considered the technology to venture capitalist Robert Swanson only ten minutes of his be insufficiently developed and the scientific world feared that time. Yet their conversation lasted three hours – and by the the search for financial rewards might endanger basic re- time it ended the idea of Genentech had been born. Further search.Itwas scarcely surprising,therefore,that the respected developments followed rapidly: 1976 On 7th April Robert Swanson and Herbert Boyer found- ed Genentech. 1978 Genentech researchers produce human insulin in cloned bacteria. 1980 Genentech shares are floated at a price of USD 35; an hour later they have risen to USD 88. 1982 Human insulin becomes the first recombinant medicine to be approved for use in the USA; the drug is marketed by the pharmaceutical company Eli Lilly under licence from Genentech. 1985 For the first time, a recombinant medicine produced by a biotech company is approved for use: Protropin, produced by Genentech (active ingredient: somatrem, a growth hor- mone for children). 1986 Genentech licenses Roferon-A to Roche. 1990 Roche acquires a majority holding in Genentech and by 1999 has acquired all the company’s shares. 1987–97 Major new drug approvals: Activase (1987; active ingredient: alteplase, for dissolving blood clots in myocardial infarction); Actimmune (1990; interferon gamma-1b, for use in chronic immunodeficiency); Pulmozyme (1992; dornase alfa, for use in asthma, cooperative project with Roche); Nutropin (1993; somatropin, a growth hormone); Rituxan (1997; rituximab, for use in non-Hodgkin’s lymphoma, coop- erative project with Idec). 1998 The humanised monoclonal antibody Herceptin (tra- stuzumab) is approved for use against a particular type of breast cancer. 1999 Fortune magazine rates Genentech as one of the ‘hun- dred best companies to work for in America’; Roche refloats Genentech on the New York Stock Exchange (NYSE). 2002 The journal Science rates Genentech as the most popu- lar employer in the field of biotechnology and pharmaceuticals. 2003–2004 Approval of Xolair (omalizumab, for use in asthma); Raptiva (efalizumab, for use in psoriasis); Avastin (bevacizumab, for the treatment of cancer). Beer for Babylon 151983 1977 1982 Walter Gilbert, Allan Maxam and Human insulin becomes the first Kary Mullis and coworkers develop Frederic Sanger present their method medicine to be produced using gene the polymerase chain reaction (PCR). for sequencing DNA. technology, ushering in the age of modern biotechnology. World’s largest biotech companies World’s largest healthcare companies by sales by sales in 2003, in million USD of biotech products in 2003, in million USD 1 Amgen (USA) 8360 1 Amgen 7866 2 Genentech (USA) 3300 2 Roche Group including 3 Serono (Switzerland) 2000 Genentech and Chugai 6191 1 4 Biogen Idec (USA) 1850 3 Johnson & Johnson 6100 5 Chiron (USA) 1750 4 Novo Nordisk 3561 6 Genzyme (USA) 1570 5 Eli Lilly 3043 7 MedImmune (USA) 1050 6 Aventis 2075 8 Invitrogen (USA) 780 7 Wyeth 1870 9 Cephalon (USA) 710 8 Schering-Plough 1751 10 Millenium (USA) 430 9 Serono 1623 10 Baxter International 1125 Source: company reports 11 Biogen 1057 1 comparative figure after the merger of Biogen and Idec in Nov. 12 Schering AG 1035 2003 13 Genzyme 879 14 MedImmune 780 15 GlaxoSmithKline 729 Many of the major healthcare companies are now also involved 16 Bayer AG 563 in the biotech sector. If these too are taken into account, the 17 Pfizer 481 following picture emerges: 18 Abbott Laboratories 397 19 Akzo Nobel 375 20 Kirin 355 Source: Evaluate Service companies or the services of contract manufacturers. As a result of the changed stock market conditions after 2000 some of these alliances evolved into takeovers: the market value of most biotech companies collapsed as abruptly as it had risen, and access to additional capital via the stock market was mostly impossible. The modern biotechnology sector is therefore now in the middle of its first wave of consolidation. 16From 1984 1990 1994 Genetic fingerprinting revolutionises The Human Genome Project is The first genetically modified forensics. launched; the German gene tomatoes are marketed in the USA. technology law is passed. Europe: Pharma enters This development did not, however, occur in the biotech sector exactly the same way all over the world. Unlike its counterpart in the USA,the European biotechnol- ogy industry soon came to be dominated by established compa- nies founded on classical biochemistry, chemistry and phar- macology. The United Kingdom, Germany, France and Scandinavia, in particular, have vibrant biotechnology sectors, while Serono, the European market leader, is a Swiss company. However the motors driving development in the world’s second most important biotech region are derived almost exclusively from the classical industrial sectors. Boehringer Mannheim (BM) provides a good example of this trend. As a supplier of laboratory equipment for use in biochem- ical research and medical diagnostics, this German company had possessed an abundance of expertise in developmental and manufacturing processes for the biotechnology sector since its very inception. As early as the 1940s BM had engaged in classi- cal biotechnology, first in Tutzing and later in Penzberg, near Munich (see box, p. 19). It made the transition to modern bio- technology during the 1980s with the introduction of a number of recombinant (i.e. genetically engineered) enzymes. In 1990 BM introduced its first genetically engineered medicine, NeoRecormon (active ingredient: erythropoietin, or EPO). In a more recently developed form, this drug still plays an important role in the treatment of anemia and in oncology. This makes it one of the world’s top-selling genetically engineered medicines – and an important source of income for the company, which was integrated into the Roche Group in 1998. Roche itself has been a pioneer of biotechnology in Europe. Like BM, Roche had had an active research and development pro- gramme in both therapeutics and diagnostics for decades. It be- gan large-scale production of recombinant enzymes as long ago as the early 1980s. In 1986 it introduced its first genetically en- Beer for Babylon 171998 2001 1997 The first draft of the human genome is For the first time a eukaryotic genome, The first human embryonic cell lines published. that of baker’s yeast, is unravelled. are established. gineered medicine, Rofer- on-A, containing interferon alfa-2a. This product for use against hairy cell leukemia was manufactured under li- cence from Genentech. After its takeover of Boehringer Mannheim, Roche devel- oped the Penzberg site into one of Europe’s biggest bio- technology centres. Following its acquisition of a majority stake in Genen- tech in 1990, Roche’s take- over of BM was the Group’s second major step into bio- technology. Finally, its ac- quisition of a majority stake in the Japanese pharmaceu- tical and biotechnology com- pany Chugai in 2002 put the Roche Group close behind the world market leader Amgen in terms of biotech sales. Roche thus provides a good example of the development of European biotechnology. Its competitors have fol- lowed a similar course, though in some cases later or with different focuses. 182003 The sequencing of the human genome is completed. ‘Big biotech’ at the foot of the Alps: Penzberg Research could scarcely be more picturesque: one of Eu- 1985 Roche is awarded German Industry’s Innovation Prize rope’s biggest biotech sites is situated 40 kilometers south of for Reflotron, an analytical device for determining blood Munich at the foot of the Bavarian Alps. For over 50 years parameters. researchers at Boehringer Mannheim, working first in Tutzing 1986 Process development work for BM’s first recombinant and later in Penzberg, developed biochemical reagents for medicine, NeoRecormon (active ingredient: erythropoietin) biological research and medical diagnostics and therapy. begins. Since Roche took over BM in 1998, Penzberg has become 1990 NeoRecormon is approved for use in the treatment of the Group’s biggest biotechnological research and produc- anemia. tion site. 1996 Rapilysin (active ingredient: tissue plasminogen activa- 1946 Working with a small research group, Dr Fritz Engel- tor, for the treatment of myocardial infarction) becomes the horn, a departmental head at C. F. Boehringer & Söhne, under- first recombinant drug to be discovered, developed and pro- takes biochemical work in the former Hotel Simson in Tutzing. duced in Germany. 1948 The amino acid mixtures ‘Dymal’, ‘Aminovit’ and ‘Lae- 1998 The Roche Group takes over BM; over the following vohepan’ become BM’s first biotechnologically produced years Roche develops the Penzberg site into one of Europe’s pharmaceuticals. biggest and most modern biotechnology centres. 1955 Under the brand name ‘Biochemica Boehringer’, BM supplies reagents for research and enzyme- based diagnostics through- out the world. 1968 The isolation of polynucleotides launches research into molecular biology. 1972 BM acquires a dis- used mining site in Penz- berg and builds a new pro- duction plant there for its rapidlyexpandingbiochem- ical and diagnostics prod- uct lines. 1977 First work in gene technology at Tutzing. 1980 Establishment of a laboratory for the produc- tion of monoclonal anti- bodies at Tutzing. 1981 Large-scale produc- tion of recombinant en- zymes begins at Penzberg. Beer for Babylon 19No newcomer to biotech: the Roche Group Roche’s line of biotechnological products dates back to the 1994 Roche takes over the US pharmaceutical company 1940s. The resulting expertise has paid off: The Roche Group Syntex and in 1995 converts it into Roche Biosciences. is now the world’s second largest biotechnology company 1998 Roche takes over the Corange Group, to which Boeh- and has a broader product base than any of its biotech com- ringer Mannheim belongs. Cooperation with deCODE genet- petitors. Its three best-selling medicines are biopharmaceuti- ics begins. cals, and almost half the sales of its top ten pharmaceutical 1999 Following its complete takeover of Genentech, Roche products are accounted for by biopharmaceuticals. Roche’s returns 42% of the company’s shares to the stock market; the Diagnostics Division supplies over 1700 biotechnology-based monoclonal antibody Herceptin is approved for use in breast products. PCR technology alone generates annual sales of 1.1 cancer. billion Swiss francs. Key milestones on the way to this success 2000 The Basel Institute for Immunology is transformed in- are listed below: to the Roche Center for 1896 Fritz Hoffmann-La Roche founds the pharmaceutical Medical Genomics. factory F. Hoffmann-La Roche & Co. in Basel. 2001 The merger of Nip- 1933 Industrial production of vitamin C begins; within a few pon Roche and Chugai years Roche becomes the world’s largest producer of vita- results in the formation of mins. Japan’s fifth largest phar- 1968 With its Diagnostics Division, Roche opens up a for- maceutical manufacturer ward-looking business segment; Roche establishes the and leading biotech com- Roche Institute of Molecular Biology in Nutley, USA. pany. 1971 The Basel Institute for Immunology is set up and fi- 2002 Pegasys (active nanced by Roche. ingredient: peginterferon 1976 Georges Köhler (a member of the Institute from 1976 alfa-2a, for use against to 1985) begins his work on monoclonal antibodies. hepatitis C) is approved 1980 Cooperation with Genentech begins; over the following for use in Europe and the decades alliances with biotech companies become a central USA; Roche sells its Vita- feature of the Roche Group’s corporate philosophy. mins and Fine Chemicals 1984 Niels Kaj Jerne and Georges Köhler of the Basel Insti- Division to DSM. tute for Immunology are awarded the Nobel Prize for Physiol- 2003 Cooperation with ogy or Medicine jointly with César Milstein; their colleague Affymetrix on the pro- Susumu Tonegawa (a member of the Institute from 1971 to duction of DNA chips 1981) is awarded the Nobel Prize in 1987. begins; AmpliChip CYP 1986 The alliance with Genentech leads to the development 450, the world’s first of Roferon-A (active ingredient: interferon alfa-2a), Roche’s pharmacogenomic medi- first genetically engineered drug; Roche introduces an HIV cal diagnostics product, test. is introduced. 1991 Roche acquires worldwide marketing rights to the 2004 New biotechno- polymerase chain reaction (PCR) from Cetus Corporation; logical production plants only two years later this technology forms the basis of the HIV are built in Basel and test Amplicor, the first PCR-based diagnostic test. Penzberg. 1992 Hivid, Roche’s first AIDS drug, is introduced. Japan: potential in Compared to their counterparts in Europe, the biotechnology pharmaceutical companies of the various Asian countries – which are otherwise so enthusiastic about new technology – were slow to recognise the potential of this new industrial sector. This despite the fact that the Japanese pharmaceutical market is the world’s second largest, after that of 20

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