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Europe's Biotech deficit – consequences and hopes

Europe's Biotech deficit – consequences and hopes. ALEXANDER VON GABAIN . “ We cannot be a strong nation unless we are a healthy nation“. President Franklin D. Roosevelt. Thread of infectious diseases - high death toll, only part of the story. AT ANY TIME.

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Europe's Biotech deficit – consequences and hopes

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  1. Europe's Biotech deficit – consequences and hopes ALEXANDER VON GABAIN “We cannot be a strong nation unless we are a healthy nation“ President Franklin D. Roosevelt

  2. Thread of infectious diseases - high death toll, only part of the story • AT ANY TIME • Every fourth human life terminated by microbial infections • 13 million deaths per year in developing countries only • 6 million children thereof • Multi-drug resistant microbes in hospitals and communities • Novel pathogens emerge • Bioterrorism • Pandemic flu, as seen 1918, with estimated 50 million deaths • Approx. 100 million people disabled by infectious diseases • 10 millions of children kept away from school due to infections • Infectious diseases deform, mutilate and disable children for life • DALY* is the greatest burden of infectious diseases • Economic burden cannot be calculated * disability adjusted life years FOPI-EFA-Symposium

  3. Chronic infectious diseases - a new paradigm in medicine Are bacteria and viruses the cause of non- inhered diseases? • Autoimmune-diseases • Bacterial infections • Arteriosclerosis diseases • Neurodegenerative diseases • Viral infections • HPV, HCV, HBV, Helicobacter infections • Cancer FOPI-EFA-Symposium

  4. Vaccines - a cost - efficientsuccess story FOPI-EFA-Symposium

  5. The vaccine field: challenges ahead and new paradigms • FORCES AT WORK • No efficacious vaccines against many infectious diseases • Many existing vaccines do not protect important population cohorts (e.g. influenza for elderly) "Come back of vaccines" • New vaccines open a wide field to prevent and to treat diseases with unmet need; e.g. HPV-induced cervix car-cinome, nicotine-dependence • Combination of therapeutic vaccines and other treatments open new therapeutics against chronic viral diseases and cancer FOPI-EFA-Symposium

  6. Industry Landscape % of market share Growing market with a restricted number of mostly US-prone vaccine players GLOBAL VACCINE MARKET Traditional and combinations US$ bn Novel and therapeutic vaccines 21.9 16.6 11.7 • Other • Sanofi-Aventis** • Novartis/ • Chiron* 8.8 6.8 2.0 • GSK * recently acquired** strategic partners of Intercell 1990 2001 2003 2005E 2007E 2009E Expected CAGR 2003 - 2009 • Merck** • Global vaccine market 16% • Novel and therapeutic vaccines 38% • Traditional and combination 0% vaccines • Wyeth Sources:Frost & Sullivan, Datamonitor, Theta Reports, Genesis, Company Information Other: Acambis, Bavarian Nordic, Baxter, Intercell,Berna Biotech*, Corixa*, ID Biomedical*, Solvay FOPI-EFA-Symposium

  7. The innovation gap of the established pharma and vaccine industry - a fact Number of new FDA approved drugs • bn US$ Pharma R&D spending Source: Phar-maceutical Research and Manu-factures of America, FDA, Burill & Co. FOPI-EFA-Symposium

  8. Biotech industry provides hope: majority of product pipeline comes from smaller biotech COMPOUNDS IN DEVELOPMENT BY COMPANY SIZE Others (mainly biotech) Top 100 Pharma players 69% Number of compounds 68% 67% 31% 55% 32% 33% 45% Source: PharmaProjects, BCG FOPI-EFA-Symposium

  9. Europe’s biotech vision or does history repeat? • "In the following 10 years the Soviet Union will out-compete the capitalist economy of the USA in terms of per capita income, economic welfare, growth and high tech" • President Nikita Krushchev, 1963 "Until 2010 Europe will overtake the US in growth of Biotech industry“ EU Lisbon Summit, 2000 FOPI-EFA-Symposium

  10. Sobering facts speak another language • Europe • US • Public listed biotech companiesin percent • Private equity investment in biotechin % of GDP • Origin of patents used by European biotechin percent • <10 • ~0.38 • ~28 • >30 • ~1.50 • ~52 FOPI-EFA-Symposium

  11. Europe versus USA – state of being behind • In US$ bn • Market cap (2005) • Revenue (2004) Biotech Companies USA • Amgen • Genentech • Genzyme • 88.78 • 87.86 • 17.74 • 10.55 • 4.62 • 2.20 • Total • 194.38 • 17.37 Biotech Companies Europe • Serono* • Actelion* • Quiagen* • 7.88 • 1.98 • 1.94 • 2.46 • 0.22 • 0.96 • Total • 11.80 • 3.64 * not truly considered as Biotechs FOPI-EFA-Symposium

  12. Underdeveloped biotech - consequences for Biomedical Research and Health Care • Health care quality will drop: European hospitals become less and less R&D drivers (e.g. compare ratio of phase I/II to phase III/IV trials Europe versus USA) • Lack of job opportunities for MDs and PhDs in Europe • Brain drain – exodus of biomedical scientists (nearly 50% of European MD/Ph.D. scientists decide to stay in the USA 1990, today more than 70%!) • Biomedical research obtains less overflow from charities FOPI-EFA-Symposium

  13. History:Spin off from the Campus Vienna Biocenter, IMP and University 1999. Today 160 employees from 16 nations in Vienna, Edinburgh & North Carolina, USA Partners:Merck (USA), Sanofi Aventis, SSI, Boehringer Ingelheim, SciGen, Biological E, EC, NIH, CDC, WRAIR, Karolinska, MPI, AERAS foundation Funding:Investors include Apax, Nomura, TVM, MPM Capital, GLSV, Sal. Oppenheim & K&W. Since 2005 listed at the ATX (ICLL): Today’s Market cap: approx. € 300m Products: Therapeutic & prophylactic vaccines based on the latest stage immunology and vaccine technology Intercell, an international biotech vaccine player, a spin off from a Viennese University Chair People:» Management board: G. Zettlmeissl (CEO), A. v. Gabain (CSO and founder) & W. Lanthaler (CFO) » Supervisory board: E.G. Afting, D. Ebsworth, M. Gréco, H. Küpper, H. Schühsler & J. Sulat » SAB: R. Ahmed, H. Blum, S. Cohen, F.X. Heinz, S. Kaufmann, S. Normark, H. Wigzell FOPI-EFA-Symposium

  14. Japanese Encephalitis(JEV) (IC51) • 2006 • Hepatitis C therapeutic (IC41) • 2008 • 2011 * ** *** **** • S. pneumoniae • 2006/07 • Group A Streptococcus • 2006/07 Advanced clinical programs – promising product pipeline and strategic partnerships • PRODUCT CANDIDATES OVERVIEW Clinical progressin last 12 month • Pre-clinical • Phase I • Phase II • Phase III • Filing • Advanced clinical product candidates • Product • Pipeline • Therapeutic Antibodies S. pneumoniae; GBS • 2006 • 2007 • Travelers diarrhea • Tuberculosis* • 2006/07 • Strategic partner- • ships • 2006 • Hepatitis B therapeutic** • S. aureus*** • 2006/07 • Bacterial vaccine **** • 2006/07 FOPI-EFA-Symposium

  15. European assets to build a robust biotech industry • High level of education • Solid academic base • Competent and good quality research at many Universities • Historical power-houses of research; Pasteur, Karolinska, Cambridge, Oxford, EMBO, Max Plank Institute, Basle Biozentrum, Campus Vienna Biocenter (Max Perutz lab., IMP IMBA) etc. • Growing number of Centers of Excellence • Long tradition of Pharma development • Excellent clinical institutions with the potential to carry out clinical research-driven studies • Growing interaction between the national biomedical scenes • Scientific output in the field of biotech is still significant still European biotech hasn’t hit the street FOPI-EFA-Symposium

  16. Thank you for your attention If you think research isexpensive, try disease Mary Lasker (1901-1994) FOPI-EFA-Symposium

  17. For more information be invited to: www.intercell.com FOPI-EFA-Symposium

  18. INFLUENZA VACCINE DISTRIBUTION (40 COUNTRIES, 2002) • Doses of influenza vaccine distributed per 1,000 population • Canada • United States • Rep. of Korea • Australia • Spain • Belgium • The Netherlands • United Kingdom • Germany • New Zealand • Italy • Iceland • France • Japan • Switzerland • Greece • Finland • Ireland • Russia • Hungary • Portugal • Sweden • Denmark • Austria • Luxembourg • Slovak Republic • Slovenia • Norway • Argentina • Brazil • Poland • Latvia • Czech Republic • Romania • Lithuania • Bulgaria • South Africa • Mexico • Turkey • Egypt Source: Journal of Public Health Policy FOPI-EFA-Symposium

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