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Europe’s Growing Biotechnology Industry. A report by Ernst & Young finds that European biotechnology is growing dramatically despite this year’s troubled financial markets. Biotechnology companies in Europe last year raised a little over $5 billion, and 39 companies went public. But despite this growth, the gap between Europe and the US is widening. Last year, the 1,273 US biotechnology companies generated revenues of 23.75 billion Euros, whereas the 1,570 European companies generated revenues of only 5 billion Euros. All the European biotechnology companies put together are slightly smaller than the US-based biotech giant Amgen. The US has fewer biotechnology companies, but they are larger and richer. This probably reflects the earlier start of the US in the world of biotechnology. In Europe, many companies are still young start-ups, and their number is likely to decrease over the coming years, through mergers and acquisitions, and sometimes failures. As far as numbers are concerned, Germany ranks first with 330 companies, followed by the UK (270), France (180), and Sweden (170). As far as revenues are concerned, the UK is strongest, with its revenues contributing almost half of European revenues. Again, this probably reflects the greater maturity of the UK-based industry compared to the rest of Europe.

Source: Q. Schiermeier. Europe’s biotech industry still losing to US, say analysts. Nature 2001; 411: 404.

Serono Competes with Biogen for MS Market. At the World Congress in Neurology in June this year, Serono presented the results of a 24-week trial (EVIDENCE) comparing its own interferon-beta (Rebif) with Biogen’s interferon-beta (Avonex) in patients suffering from relapsing-remitting multiple sclerosis (MS). Serono claims that patients treated with Rebif did significantly better than patients treated with Avonex both on the primary and on secondary end-points. For example, at the end of the study, only 25.1% of patients on Rebif had relapsed as opposed to 36.7% of patients on Avonex. Biogen, whose stock fell 9% on the first day of trading after the announcement, contends that the study was not blinded, both the patients and the physicians knew what treatment they were receiving (but the evaluating physicians did not). Biogen also criticizes the short duration of the trial, and the fact that the primary end-point was time to relapse rather than disability progression. Serono responds that the study design had been agreed upon with FDA, and that the nature of the treatments made it impossible to blind the trial. Serono also points out that four-year data (PRISMS study) using impairment and disability scores as primary end-points are now available (Neurology 56; 1628; 2001) and confirm a better response to Rebif. Biogen is now highlighting the greater incidence of neutralizing antibodies with Rebif than with Avonex, although the clinical significance of these antibodies is unclear. Serono is expected to file an NDA for Rebif before the end of 2001. Perhaps the most surprising for us is that, 10 years ago, many pharmaceutical companies viewed the market for MS as too small to warrant any research.

Source: Davidson S. Biogen, Serono squabble over MS market. Nature Biotechnology 2001; 19: 696-698.

GM Cows for Multiple Sclerosis. Researchers at AgResearch in New Zealand, have inserted the gene for human myelin basic protein into the embryonic calves. The objective is to obtain cows that will produce high levels of the protein in their milk. The hope is to use the protein to develop new treatments for multiple sclerosis. The experiment had been approved by the Environmental Risk Management Authority (ERMA), the statutory body that approves genetic engineering experiments in New Zealand, but activists and Maoris challenged the approval, and the New Zealand High Court may rule that the pregnant cows must be slaughtered.

Source: Bob Brockie. GM cows face slaughter in multiple sclerosis experiment. Nature 2001; 411: 402.

Analysts Examine The Impact of Genomics on the Cost of Drug Development
Analysts are divided on the impact of genomics on the cost of drug discovery and development. According to a recent Lehman-McKinsey report - Fruits of Genomics - gene-based drug discovery will cause the price of R&D to soar. The reasons given are the huge increase in targets, causing drug discovery costs to double. In addition, since many of these targets are not validated, there is a heightened risk of failures, further increasing the cost of drug development.

By contrast, the Boston Consulting Group (BCG) is optimistic and believes that the smart application of genomics will reduce the cost of developing drugs from $880 million currently to $580 million. According to the BCG this reduced cost will be mainly due to more efficient and therefore faster clinical development. They predict that the industrialization of gene-based drug discovery will shorten the development process by two years.

Lehman Brothers & McKinsey & Co. The Fruits of Genomics (Lehman Brothers, New York, 2001.)

WEB LIST OF SCIENTISTS WITH TIES TO INDUSTRY
A US Consumer advocacy group - Center for Science in the Public Interest (CSPI) - has posted on the web a database which describes the ties between scientists and industry. The list contains information on commercial funding and consulting work and can be found at www.cspinet.org/integrity/database.html

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