Gerechtigkeit und Forschungsfinanzierung Was macht Deutschland?

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1 zum Fortschritt im Gesundheitswesen von morgen Gerechtigkeit und Forschungsfinanzierung Was macht Deutschland? Prof. Dr. Dr. h. c. Günter Stock Präsident der Berlin-Brandenburgischen Brandenburgischen Akademie der Wissenschaften

2 Quelle: Key Figures , European Commission; Statistisches Jahrbuch 2003, Statistisches Bundesamt R&D expenditure in comparison (2001) 315 USA 52 Deutschland in Milliarden Euro USA 175 EU

3 R&D expenditure in the US according to selected disciplines Forschungsfinanzierung a) in den USA nach thematischer Ausrichtung (Summe Wissenschaft und Wirtschaft, in Mrd. US-$ $ zu Preisen von 2000) Quelle: Technologie und Qualifikation für neue Märkte, ergänzender Bericht zur technologischen Leistungsfähigkeit Deutschlands , Hrsg. BMBF 3

4 Finanzierungsanteil des Staates an Forschungs- u. Entwicklungsaufwendungen der Wirtschaft (in Prozent) Quelle: Fraunhofer-Gesellschaft (Büro der Forschungsunion Wirtschaft-Wissenschaft) eigene Berechnungen auf Basis von BMBF

5 Wege zu günstigen Arzneimitteln Quelle: Verband forschender Arzneimittelhersteller VfA ( 5

6 Erfolgsraten in der pharmazeutischen F&E Gründe für einen Ausfall ( ) Ausfall nach Kriterium (%) Klinische Wirksamkeit Formulierung PK/ Kommerziell Toxikologie Waren- Unbekannt/ Sicherheit Bioverfügbarkeit kosten Sonstige Quelle: Nature Reviews, Drug Discovery, Volume 3 l August 2004; S Perspectives I. Kola & J. Landis Can the pharmaceutical industry reduce attrition rates? 6

7 Success Rates in Pharmaceutical R&D The data are from the ten biggest drug companies during (The companies are AstraZeneca, Bristol- Myers Squibb, Eli Lilly, F. Hoffmann La-Roche, GlaxoWellcome, Johnson & Johnson, Novartis, Pfizer, Pharmacia, Schering Plough and SmithKline Beecham; data were obtained by Datamonitor in the Pharmaceutical Benchmarking Study.) Source: Nature Reviews, Drug Discovery, Volume 3 l August 2004; p Perspectives I. Kola & J. Landis Can the pharmaceutical industry reduce attrition rates? 7

8 Projekte forschender Pharmafirmen für neue Arzneimittel gegen Krankheiten der Entwicklungsländer Krankheit Projekte f. Medikamente zur Behandlung (davon in klinischer Erprobung/ Zulassung) Projekte für Impfstoffe (davon in klinischer Erprobung/ Zulassung) Malaria 22 (10) 4 (3) Tuberkulose 20 (7) 2 (2) Dengue-Fieber 3 (0) 2 (2) Schlafkrankheit 6 (1) - Chagas-Krankheit 3 (0) - Bilharziose 1 (0) - Leishmaniasen 3 (1) 2 (0) Flussblindheit 1 (1) - Rotaviren - 2 (2) Pneumokokkeninfektion - 8

9 Patents are not a Barrier to Medicine Access In many markets where patent laws have been introduced relatively recently, access to medicines has improved. More likely than patents, other causes including poverty, medical regulatory regimes in the various countries, tariffs and sales taxes, and a lack of international aid to fund AIDS treatments impede access to antiretroviral treatments in Africa. 1) In 65 low- and middle-income countries (4 billion people 2/3 of world population), patenting for essential medicines is rare (overall patent incidence of 1.4 %). 2) Thus, there is no patent barrier for generics in 98.6% of the essential medicines. Other causes such as poverty and poor infrastructure are limiting the access to medicines. 1) A. Attaran and L. Gillespie-White, Journal of the American Medical Association, 2001, Vol ) A. Attaran, Health Affairs, Vol. 23, A. Attaran is a fellow in the Royal Institute of International Affairs in London 9 9

10 Birth of an Industry (I) 1953 DNA structure proposed by James Watson and Francis Crick 1960 Arthur Kornberg synthesizes DNA in vitro 1970 Hamilton Smith and Kent Wilcox isolate the first restriction enzyme 1971 The first biological engineering company, Cetus, founded 1972 Paul Berg uses a restriction enzyme to form a hybrid circular molecule 1973 Stanley Cohen and Herbert Boyer develop DNA cloning and recombinant DNA 1976 Robert Swanson and Herbert Boyer found Genentech 1977 Genentech clones the hormone somatostatin in bacteria, the first cloning of a protein using a synthetic recombinant gene 1978 Biogen founded, now the oldest independent biotech company Genentech and City of Hope National Medical Center announce the successful production of human insulin 1980 Amgen founded Leroy Hood and Mike Hunkapiller develop protein sequencer Fred Sanger and colleagues develop the shotgun method for sequencing genomes Source: E. Russo, Nature Vol. 421,

11 Birth of an Industry (II) 1983 Kary Mullis invents the polymerase chain reaction 1986 US Environmental Protection Agency approves release of genetically altered tobacco, the first genetically engineered crop 1987 Susan Horvath, Mike Hunkapiller and Leroy Hood develop DNA synthesizer 1988 Philip Leder and Timothy Stewart are awarded patent for mouse breast-cancer model, the first patent given for a genetically altered animal 1994 US Food and Drug Administration deems the Flavr Savr, a genetically modified tomato, safe, thus bringing to market the first transgenic food product 1997 Roslin Institute scientists clone Dolly the sheep, the first mammal to be cloned successfully from an adult cell 1998 Independent teams led by James Thomson and John Gearhart are the first to grow embryonic stem cells successfully 2001 Public and private teams publish draft versions of the human genome sequence 2002 Over 200,000 jobs exist across 4,000 biotech companies worldwide (Ernst & Young) Source: E. Russo, Nature Vol. 421,

12 2006: More than 50 years ago Watson & Crick decoded the DNA structure Watson and Crick with their DNA model in the Cavendish Labor in Cambridge, 21 st May 1953 (Photo from Anthony Barrington Brown) 12

13 Biopharmazeutika bestimmen wesentliche Therapiebereiche Insbesondere bei Stoffwechsel-, Infektions-, Krebs- und immunologischen Erkrankungen Anteil Biopharmazeutika am Gesamtpharmamarkt (Umsatz Deutschland 2007) CAGR Beispiel: Interferone-beta/ Multiple Sklerose 10% 7% 37% 52% -3% 17% 48% 11% ZNS Beispiel: Impfstoffe/menschliche Papillom-Viren Beispiel: Insuline/ Diabetes 24% 32% Beispiel: Cetuximab/ Darmkrebs 25% Beispiel: Epoetine/ Anämie 21% 51% Stoff-wechsel Infektion Onko-logie Immuno-logie Hämato-logie 1 Beispiel: TNFα-Inhibitoren/ Rheumatoide Arthritis Andere 2 "Medizinische Biotechnologie in Deutschland 2008" Boston Consulting Group/VFA Bio Beispiel: Omalizumab/ Asthma Gesamtpharmamarkt 26,8 Mrd. 3 Biopharmazeutika (15%) 4,0 Mrd. (CAGR 19 %) 1. Exklusive hämatologische Onkologie 2. u. a. Gastroenterologie, Dermatologie, Urologie etc. 3. Umsatz in Krankenhaus und Apotheke zu Herstellerabgabepreisen 4. CAGR = Compound Annual Growth Rate Quelle: IMS; VFA-Mitgliedsunternehmen; EvaluatePharma; BCG-Analyse 2%

14 Anteil an neu zugelassenen Wirkstoffen weiterhin hoch Biopharmazeutika mit Anteil von Prozent an Neuzulassungen in Deutschland Zahl der neu zugelassenen Wirkstoffe in Deutschland 29% 33% 24% 20% 18% 23% 31% 25% Anteil Biopharmazeutika Biopharmazeutika Andere Quelle: EMEA; Europäische Kommission; VFA; BCG-Analyse "Medizinische Biotechnologie in Deutschland 2008" Boston Consulting Group/VFA Bio

15 Medizinische Biotechnologie schafft Arbeitsplätze Zahl der Mitarbeiter um 14 Prozent gestiegen Anzahl der Unternehmen in Deutschland 2007 Beschäftigte der Unter-nehmen in Deutschland 2007 Umsatz der Unternehmen in Deutschland 2007 (in Mio. ) Vergleich zu % 371-3% +14% ( ) % +24% % % +15% +26% Unternehmen mit Technologieplattform 3 Unternehmen mit Produkten am Markt und/oder Wirkstoffentwicklung 1. Umsatz mit Biopharmazeutika (Krankenhäuser und Apotheken) 2. Umsatz mit Lizenzen, Meilensteinzahlungen, Serviceleistungen etc. von aufstrebenden Unternehmen (Umsatz < 30 Mio., Quelle: Geschäftsberichte); BCG-Schätzung 3. Aber ohne eigene Wirkstoffentwicklung Quelle: Bureau van Dijk; VFA-Mitgliedsunternehmen; Ernst & Young 2007; BCG-Analyse "Medizinische Biotechnologie in Deutschland 2008" Boston Consulting Group/VFA Bio

16 Innovation First approved MS Therapy Betaferon approval as 1993 orphan drug Introduction of MRI as an MRI results critical in FDA innovative technology to approval besides clinical assess treatment outcomes endpoints 1993/95 Definition of MS includes MRI criteria MRI criteria integral part of MS diagnosis and therapy monitoring Definition of MS (McDonald criteria) based on MRI criteria

17 Advances in MS-Management Management Improved diagnostic techniques (McDonald-criteria) Pathology more completely understood Greater emphasis on early diagnosis and management Effective treatment A more positive future for MS-patients and their management 17 17

18 4000 Years of Female Contraception Instructions from Egyptian papyri (1850 B.C.E.) - Vaginal application of crocodile dung as pessary or paste... - Cotton tampons or sponges filled with honey, sodium bicarbonate, fluid from pomegranate The First Pill in Europe: Anovlar (1961) B.C.E. The Greek philosopher Aristotle is thought to be the first person to propose using natural chemicals such as cedar oil, lead ointment or frankincense oil as spermicides. Source: 18

19 The First Oral Contraceptive in Europe: Anovlar (1961*) * first Anovlar launch: Australia; January 01,

20 Transition of Concepts Contraceptives for Fertility Control Family Planning Family Spacing and Female Health 20 20

21 OC s: : there is more than Contraception Contraceptive Benefits + Additional Benefits Unwanted pregnancies Abortions (induced & spontaneous) Ectopic pregnancies Morbidity/Mortality in pregnancy Cycle control ~50% Dysmenorrhea ~60% Anemia ~25% Acne, Seborrhea ~80% PCO ~50% Premenstrual Syndrome ~25% Pelvic inflammatory disease~50% benign ovarian tumors ~80% benign breast tumors ~50% Endometriosis ~50% Ovarian-Ca. ~50% Endometrium-Ca. ~50% 21

22 Yasmin has Proven the Value of Contraceptives with Added Benefits Added Benefits Safety Acne... PMS/PMDD Safety Safety Added Benefits Efficacy

23 The Future: Challenges and Tasks 2000 YAZ 2005 FC Patch E2 Pill 2010 Contraceptives with new progestins that have added benefits e.g. DRSP New application forms e.g. patch more choices Contraceptives with estradiol instead of ethinyl estradiol (various and new compounds, dosages, regimens and application forms) concept of added benefit fertility control on demand non-hormonal methods male fertility control Contraceptives with unique added benefits e.g. dysfunctional uterine bleeding Our FC pipeline is best in the business 23 23