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THE VALUE OF MEDICAL INNOVATION EUROPE
Discovery consists of seeing what everybody has seen and thinking what nobody has thought. “
“ Albert Szent-Györgyi, Nobel Laureate for Medicine
Good. The Scientist Speculates. 1963
2
SUMMARY
Medical innovation contributes significantly to our ability to live longer, healthier and more prosperous lives. It has had a clear impact in many diseases, including polio, diabetes, heart disease, HIV and, in recent years, cancer. Improvements in life expectancy and quality of life can be attributed directly to medical innovation, and today, patients are reaping the rewards of the significant investment made in research over the past decades. Celgene is committed to medical innovation and has delivered significant improvements in overall survival and quality of life for patients. We continue to take bold and pioneering steps with a diverse pipeline of new therapies.
Our aspiration is to change the course of the diseases that we treat, making them manageable chronic diseases and, one day, we hope to offer a cure
3
CONTENTS Introduction Chapter 1: Living longer, better & healthier
Chapter 2: The cost of the cure: exploding the myths
Chapter 3: Progress & prosperity
Chapter 4: The virtuous cycle of innovation and how to sustain it
4
BETTER & HEALTHIER 2 3 4
LIVING LONGER, BETTER & HEALTHIER MEDICAL PROGRESS, INCLUDING BIOMEDICAL INNOVATION, HAS LED TO LONGER AND HEALTHIER LIVES FOR PEOPLE ALL OVER THE WORLD.
Vaccines, antibiotics and cardiovascular medicines have accounted for tremendous medical gains in the past 100 years, but the pace of innovation in the past 5 to 10 years with respect to cancer and other deadly conditions is equally astonishing. Investment, research and development by companies like Celgene has played a critical role.
5
1
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
EUROPE HAS WITNESSED BREATHTAKING MEDICAL BREAKTHROUGHS IN THE PAST CENTURY
“It is difficult to convey the excitement of actually witnessing the amazing power of penicillin over infections for which there had previously been no effective treatment. I could not then imagine the transformation of medicine and surgery that penicillin would produce.” Charles Fletcher, who became the first doctor to inject a human subject with penicillin at the Radcliffe Infirmary, Oxford
6
Fletcher. Br Med J (Clin Res Ed) 1984;289:22–29
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
LIFE EXPECTANCY GAINS ARE CLEAR
7
OECD Health Statistics. http://dx.doi.org/10.1787/health-data-en. Accessed 21 Jan 2014
25 20 15 10 5 0 4 2 0 8 10
6
Life expectancy at age 65, 2011 and years gained since 1960 (or nearest year) Life expectancy at 65, 2011 Years gained, 1960–2011
France Spain Italy
Switzerland Portugal Austria Finland
Luxembourg Belgium Iceland Norway Sweden
Germany Israel
Netherlands United Kingdom
Slovenia Ireland Greece
United States Estonia Poland
Denmark Czech Rep. Slovak Rep.
Hungary Russian Fed.
Turkey
Men Women
N/A
N/A
N/A
N/A
Years Years
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
PROGRESS AGAINST DISEASES 1960–2012
8
Adapted from: American Society of Clinical Oncology. www.cancerprogress.net
1960
1970
1980
1990
2000
2010
1960 Polio Vaccine
1963 Measles Vaccine
1967 First Beta Blockers
1965 Surfactants for
Infant Respiratory Distress
1974 Meningococcal
Disease Vaccine
1981 First ACE Inhibitor to Treat High Blood
Pressure
1981 Hepatitis B
Vaccine
1986 First Monoclonal
Antibody
1987 SSRIs (Anti-
depressants)
1989 Statins for Cholesterol
1989 First HIV
Drugs
1993 First
Alzheimer’s Rx
1995 New HIV
Drugs
1994 Breast Cancer Rx 1995 – AIDS Rx
Advance (HAART)
1996 First Enzyme Replacement
Drug for Gaucher's Disease
1998 First Blood Thinners
for Heart Attack, Stroke
2001 Targeted Therapy
Approved for Leukaemia
2004 Anti-angiogenic
Approved for Colon Cancer
2008 Immunomodulator
Approved for Multiple Myeloma
2010 Targeted
Therapies for Lung, Colon, Prostate and Skin Cancer
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
NEW THERAPIES ARE A GREAT CONTRIBUTOR TO INCREASED LIFE EXPECTANCY
9
Lichtenberg. Pharmaceutical innovation and longevity growth in 30 developing and high-income countries, 2000-2009. NBER Working Paper No. 18235, issued in July 2012
1960 – 1997 New therapies account for 45% of
the increase in life expectancy
2000 – 2009 New therapies account for 73% of the increase in life expectancy
45% 73%
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
HIV/AIDS CASE STUDY: RATES OF HIV INFECTION IN EUROPE REMAIN HIGH
10
ECDC/WHO. HIV/AIDS Surveillance in Europe, 2012
0
7 6 5 4 3 2
1
1984 1986 1988 1990 1992 1994 2002 2004 2006 2008 2010 2012
12 18 19 22 23 22 25 25 25 26 26 26 26 26 26 26 26 27 26 28 30 30 30 30 30 30 30 30 30 Countries reporting
Rat
e pe
r 100
,000
pop
ulat
ion
1996 1998 2000
Year of diagnosis
Rate of reported HIV diagnoses, by year of diagnosis, in the EU/EEA, 1984–2012
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4 11
0
HIV/AIDS CASE STUDY: DECREASE IN NUMBER OF AIDS DEATHS IN EUROPE SHOWS IMPACT OF INNOVATIVE MEDICINES
Number of deaths in 17 EU countries* where Eurostat data is available, since 1994
16000
12000
8000
4000
1994 1996 1998 2006
Num
ber
2000 2002 2004 Year
EUROSTAT Mortality statistics, AIDS (HIV disease, ICD-10 B20-B24)
EuroHIV deaths notifications in AIDS cases
* CZ, DN, DE, IE, GR, SP, IT, LX, HU, NL, AU, PL, PT, SL, FI, SW, UK EMCDDA. http://www.emcdda.europa.eu. Accessed 21 Jan 2014
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
HIV/AIDS CASE STUDY:
12
ANTIRETROVIRALS HAVE SAVED MILLIONS OF LIVES Annual number of people dying from AIDS-related causes in low- and middle-income countries
globally compared with a scenario of no antiretroviral therapy, 1996–2012
1 000 000
500 00
3 000 000 2 500 000 2 000 000 1 500 000
AID
S-re
late
d de
aths
0 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012*
*The data points for 2012 are projected based on the scaling up of programmes in 2009–2011 and do not represent official estimates of the number of annual AIDS-related deaths
EMCDDA. http://www.emcdda.europa.eu. Accessed 21 Jan 2014
AIDS-related deaths at the current coverage of ART
AIDS-related deaths without ART
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
“The life-saving benefits of ART are vividly evident. Before ART, about 80% of the people presenting at clinics with AIDS-defining illnesses died within two years, but even the most severely ill people living with HIV today have at least an 80% chance of survival after two years of ART.” GLOBAL UPDATE ON HIV TREATMENT 2013: RESULTS, IMPACT AND OPPORTUNITIES, JUNE 2013 WHO report in partnership with UNICEF and UNAIDS
HIV/AIDS CASE STUDY: ANTIRETROVIRALS HAVE MADE HIV A CHRONIC DISEASE THAT CAN BE MANAGED AND SURVIVED – AND INNOVATION HOLDS THE SAME PROMISE FOR CANCER
13
WHO. Global update on HIV treatment 2013. http://apps.who.int/iris/bitstream/10665/85326/1/9789241505734_eng.pdf. Accessed 21 Jan 2014
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4 14
In 2005, a man diagnosed with multiple myeloma asked me if he would be alive to watch his daughter graduate from high school in
a few months. In 2009, bound to a wheelchair, he watched his daughter graduate from college. The wheelchair had nothing to do
with his cancer. The man had fallen down while coaching his youngest son's baseball team.
“ “ Dr. Siddhartha Mukherjee, Author, The Emperor of All Maladies
Mukherjee. The Emperor of All Maladies: A Biography of Cancer. 2010
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4 15
Soerjomataram et al. Lancet 2012;380:1840–1850
Projected in2040
96 million
THE PROMISE OF MEDICAL INNOVATION = FEWER LIVES LOST
Life years lost to cancer
2010 160 million 40% REDUCTION
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4 16
CANCER MORTALITY IS DECREASING IN EUROPE
OECD Health Statistics. http://dx.doi.org/10.1787/health-data-en. Accessed 21 Jan 2014
-28 -27 -25
-23 -22 -21 -20 -20 -20 -20 -19 -17 -17 -16 -16 -15
-13 -12 -12 -10 -10
-6 -6 -4 -4 -3
0
Cha
nge
in %
ove
r the
per
iod
-40
Change in all cancer mortality rates, 1990–2011 (or nearest year)
20
10
0
-10
-20
-30
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4 17
CANCER SURVIVAL RATES ARE INCREASING ALMOST EVERYWHERE IN EUROPE
Ferlay et al., Ann Onc 2010; and Ferlay et al. Eur J Cancer 2013;49:1374-1403 (CUTS data)
Cancer survival rates 2012 (1 minus mortality/incidence)
70%
60% 50% 40% 30% 20% 10%
0%
2008 data
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4 18
Ann Oncol 2007;18 (suppl 3): iii67–iii77
IN A 20-COUNTRY SAMPLE, INNOVATIVE CANCER THERAPIES GENERATED A 30% DECLINE IN THE CANCER MORTALITY RATE
Contribution of the increase in cancer drug vintage to the decline in the age-adjusted cancer mortality rate
2001 2002 2003
0.85
0.80
1.05
Actual 1.00
If no increase in drug vintage 0.95
0.90
Increase in drug vintage accounts for 30% of the 1995–2003 decline in age-standardized cancer mortality rate
1995 1996 1997 1998 1999 2000
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
SURVIVAL RATE FOR MYELOMA PATIENTS RISES WITH NEW INNOVATIVE THERAPIES
19
National Cancer Institute, Surveillance Epidemiology and End Results. http://seer.cancer.gov/csr/1975_2009_pops09/browse_csr.php?section=18&page=sect_18_table09.html. Accessed 21 Jan 2014
47 45 43 41 39 37 35 33 31 29 27
1992 1995 2008 2000 Year of diagnosis
5-Ye
ar S
urvi
val R
ates
(%) 5-year relative survival rate, myeloma
50% INCREASE
1992–2008
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
FIVE-YEAR SURVIVAL FROM MYELODYSPLASTIC SYNDROMES (MDS) INCREASING
20
Smout et al. Age Period Cohort Analysis of Cancer Survival In SEER 18 Registry. Center for Medicine in the Public Interest
2004 2008
+60% 24% 38%
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
THE COST OF THE CURE: EXPLODING THE MYTHS THE COST OF THESE MEDICAL ADVANCES IS NOT OVERWHELMING. ON THE CONTRARY, CANCER CARE, INCLUDING INNOVATIVE MEDICINES, REPRESENTS A SMALL SHARE OF HEALTHCARE COSTS.
Innovative cancer treatments that produce longer and better lives can ultimately reduce the direct costs of cancer care to health care systems, as well as the broader economic and social burden associated with cancer across Europe.
21
2
THE COST OF THE CURE: EXPLODING THE MYTHS
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BETTER & HEALTHIER 2 3 4 22
Cancer’s Challenge for Europe
Cancer is everybody’s business. In 2012 alone, 3.2 million people in Europe will be diagnosed for the first time with cancer, about 13 million people will be affected and 1.2 million will die
from this disease. For this reason, cancer research and innovation are a priority for the European Union.
“ “ Máire Geoghegan-Quinn, EU Commissioner for Research and Innovation
European Cancer Organisation. Oncopolicy Forum 2012 Report. http://www.ecco-org.eu/Publics-affairs/Oncopolicy-Forum-and-Events/Oncopolicy-forum/2012.aspx. Accessed 21 Jan 2014
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4 23
GROWTH IN PHARMACEUTICAL SPENDING HAS DECLINED
OECD Health Statistics. http://dx.doi.org/10.1787/health-data-en. Accessed 21 Jan 2014
Average annual growth rates of health spending for selected functions, in real terms, OECD average, 2008–2011
4.8
5.9
6.9
2.5
3.2
4.8 4.6
6.2
2.9 2.8
6.4
3.5
0.7 0.9
5.3
0.2
-0.9
1
1.7 1.6
-1.7 -1.5 -1.7
1.7
Inpatient care Outpatient care Long-term care Pharmaceuticals Prevention Administration
8
7
6
5
4
3
2
1
0
-1
-2
-3
2007-08 2008-09 2009-10 2010-11
%
THE COST OF THE CURE: EXPLODING THE MYTHS
PROGRESS & PROSPERITY
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT
BETTER & HEALTHIER 2 3 4
COST OF TREATING CANCER REMAINS A SMALL PORTION OF TOTAL HEALTHCARE EXPENDITURES…
Direct cost for cancer in study countries in 2002/2003. Total in million Euro, per capita Euro and share of total healthcare expenditures.
24
Karolinska Institutet. http://ki.se/content/1/c4/33/52/Cancer_Report.pdf. Accessed 21 Jan 2014
Direct costs for cancer
(€ million)
Direct costs for cancer per capita
(€)
Cancer costs as % of total healthcare costs
Total healthcare expenditure (€ million)
Population (2003) Total 54,263 120 6.4 844,800 451, 263,000
Austria 923 114 6.5 14,200 8,067,000
Belgium 1,469 142 6.5 22,600 10,372,000
Czech Republic 663 65 6.5 10,200 10,202,000
Denmark 748 139 6.5 11,500 5,387,000
Finland 587 113 6.9 8,500 5,213,000
France 7,091 119 5.3 133,800 59,768,000
Germany 12,100 150 5.4 224,000 82,502,000
Greece 1,112 101 6.5 17,100 11,036,000
Hungary 566 56 6.5 8,700 10,124,000
Ireland 468 118 6.5 7,200 3,953,000
Italy 6,578 114 6.5 101,200 57,478,000
The Netherlands 1,525 94 4.1 37,200 16,224,000
Norway 871 191 6.5 13,400 4,564,000
Poland 1,300 34 6.5 20,000 38,195,000
Portugal 943 90 6.5 14,500 10,449,000
Spain 3,855 92 6.5 59,300 41,874,000
Sweden 1,253 140 7.0 17,900 8,958,000
Switzerland 1,391 189 6.5 21,400 7,343,000
UK 10,823 182 10.6 102,100 59,554,000
THE COST OF THE CURE: EXPLODING THE MYTHS
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BETTER & HEALTHIER 2 3 4
…AND MEDICINES REPRESENT THE SMALLEST SHARE OF SPENDING ON CANCER CARE
Cancer healthcare costs as a proportion of total costs and distribution of direct costs of cancer on inpatient care, ambulatory care and drugs.
25
Karolinska Institutet. http://ki.se/content/1/c4/33/52/Cancer_Report.pdf. Accessed 21 Jan 2014
Cancer costs as % of total
healthcare costs
Inpatient care Ambulatory care Drugs Total
Germany (2002) 5.4% 67% + 9% other 16% 8% 100%
Sweden (1996) 6% 94% Not included in the estimate 6% 100%
Sweden (2002) 10% 75% (hospital) 15%
(including home care)
10% 100%
France (1998) 5.3% 83% 7%
+ 6% transport costs
4% 100%
The Netherlands (1994) 4.6%
60% + 11% non-hospital
institutional care 18% 11% 100%
THE COST OF THE CURE: EXPLODING THE MYTHS
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BETTER & HEALTHIER 2 3 4
INNOVATION CANNOT STOP: CANCER INCIDENCE IS INCREASING WORLDWIDE IN PEOPLE 55 AND OVER
26
International Agency for Research on Cancer, World Health Organization. Cancer Incidence in Five Continents CI5. 2010
1950 1960 1970 1980 1990 2000 2010 2020 2030
40
35
30
25
20
15 10
5
0
Projected 45
CAGR: Compound Annual Growth Rate
Age
55
and
Ove
r as
% o
f Pop
ulat
ion
with
Can
cer
CAGR ’10-’30 = 1.5%
CAGR ’10-’30 = 2.8%
CAGR ’10-’30 = 3.3%
Developed
Worldwide
Developing
THE COST OF THE CURE: EXPLODING THE MYTHS
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BETTER & HEALTHIER 2 3 4
CANCER INCIDENCE AND MORTALITY IN EUROPE ARE PREDICTED TO INCREASE BY 2020
Mortality from and incidence of cancer by main types in the European Region, 2010 and projected for 2020
27
WHO. The European health report 2012. http://www.euro.who.int/ data/assets/pdf_file/0004/197113/The-European-health-report-2012.-Charting-the-way-to-well-being.pdf. Accessed 21 Jan 2014
Colorectum
Breast
Lung
Prostate
Stomach
Bladder
Kidney
Pancreas
Non-Hodgkin’s lymphoma
Number of deaths Number of new cases
600 000 400 000 200 000 200 000 400 000 600 000 0
Mortality
2010
2020
Mortality
2010
2020
THE COST OF THE CURE: EXPLODING THE MYTHS
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BETTER & HEALTHIER 2 3 4
A GRAVE BURDEN: CANCER COST THE EU €126 BILLION IN 2009
28
“Cancer poses a considerable economic burden not only to healthcare systems [in Europe] but to other areas of the economy, including productivity losses through early mortality and time off work, and relatives who have to forego work/leisure to care for cancer patients.” Dr Ramon Luengo-Fernandez, Oxford University, leader of a study on the true cost of cancer for the EU
The Independent. http://www.independent.co.uk/life-style/health-and-families/health-news/cancer-costs-eu-99bn-per-year-8190248.html. Accessed 21 Jan 2014
THE COST OF THE CURE: EXPLODING THE MYTHS
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BETTER & HEALTHIER 2 3 4 29
The Stakes for Europe
There are between 6000 and 8000 rare diseases and despite their rarity, such diseases affect 6–8% of the population,
representing approximately 30 million EU citizens. “ “ The Alliance for Biomedical Research in Europe
http://www.eacr.org/user_uploads/files/news/Draft%20Scientific%20Case%20Studies%20BioMed%20Alliance.pdf. Accessed 21 Jan 2014
THE COST OF THE CURE: EXPLODING THE MYTHS
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PROGRESS & PROSPERITY MEDICAL INNOVATION LEADS TO GREATER ECONOMIC GROWTH AND PROSPERITY.
Medical innovation leads to improved health outcomes, higher productivity, reduced disability, and greater economic value to society. The biomedical sector, including companies like Celgene, make significant contributions to Europe’s economy.
30
3
THE COST OF THE CURE: EXPLODING THE MYTHS
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Over the last half century, improvements in health have been as valuable as all other sources of economic growth and productivity combined. “ “
University of Chicago Economists Kevin Murphy, Ph.D., and Robert Topel, Ph.D.
THE COST OF THE CURE: EXPLODING THE MYTHS
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LIVING LONGER, BETTER AND HEALTHIER BENEFITS SOCIETY
32
*Extended survival contributes to economic stimulus by affording people more time to purchase and enjoy leisure activities
Murphy and Topel. J Political Econ 2006;114(5):871–904
Maximizes life expectancy
Improves quality of life
Boosts the economy
$500 billion In Societal Value
A 1%
REDUCTION in CANCER-related DEATHS in the USA
THE COST OF THE CURE: EXPLODING THE MYTHS
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BETTER & HEALTHIER 2 3 4 33
The European-based pharmaceutical industry makes a major contribution to the EU, not just in economic terms but also in terms of high-quality employment, investment in the science base and
in terms of public health. “ “
Pharmaceuticals in Europe: Facts and Figures, The European Commission, DG Enterprise and Industry
European Commission. http://ec.europa.eu/enterprise/sectors/healthcare/competitiveness/importance/facts-figures_en.htm. Accessed 21 Jan 2014
THE COST OF THE CURE: EXPLODING THE MYTHS
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NEARLY A QUARTER OF ALL BIOPHARMACEUTICAL INNOVATION ORIGINATES IN EUROPE Europe produces nearly one quarter of all new innovative therapies and biotech patents in the world
34
Macher and Mowry. Innovation in Global Industries: U.S. Firms Competing in a New World (Collected Studies), Washington DC: The National Academies Press, 2008
E.U. (24.8%)
USA (64.4%)
Japan (10.7%)
Other OECD (6.0%)
India (1.1%)
China (0.2%)
Other (2.8%)
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GREAT SOURCE OF HIGH-QUALITY JOBS IN EUROPE
35
EFPIA. http://www.efpia.eu/facts-figures. Accessed 21 Jan 2014
OPEN
Each direct biopharmaceutical job supports 3–4 additional
jobs in other sectors
TOTAL JOBS SUPPORTED Over 2 million total EU jobs supported by the
biopharmaceutical sector
BIOPHARMA JOBS More than 700,000 jobs in the EU biopharmaceutical sector
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INVESTMENTS IN MEDICAL INNOVATION YIELD
36
SIGNIFICANT ECONOMIC BENEFITS TO EUROPE The European Union’s top 5 pharmaceutical trading partners – EU Exports 2012
In 2012, medical innovators contributed a trade surplus of 80 billion euros to the EU
EFPIA http://www.efpia.eu/index.php?mact=FactsFigures,cntnt01,default,0&cntnt01limit=6&cntnt01orderby=category%20ASC&cntnt01page=1&cntnt01returnid=23&cntnt01returnid=23. Accessed 21 Jan 2014
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THE BIOPHARMACEUTICAL SECTOR IS THE MOST R&D-INTENSIVE IN THE EU
Ranking of industrial sectors by overall sector R&D intensity (R&D as percentage of net sales – 2011)
37
Pharmaceuticals & biotechnology
Software & computer services
Technology hardware & equipment
Leisure goods
Health care equipment & services
Electronic & electrical equipment
Automobiles & parts
Aerospace & defence
All sectors
Chemicals
Industrial engineering
General industrials
Banks
Fixed line telecommunications
Food producers
Oil & gas producers
0 5 10 15 20 Note: Date relate to the top 1,500 companies with registered offices in the EU, Japan, the USA and the Rest of the World,
ranked by total worldwide R&D investment (with R&D investment above €34.9 million) EFPIA. http://www.efpia.eu/uploads/Figures_Key_Data_2013.pdf. Accessed 21 Jan 2014
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…biomedical and clinical research generates more than 50 per cent of the research output in Europe, as measured by the number of journal
papers and citation. “ “ Professor Roger Bouillon of the European Medical Research Councils Core Group
Science Business. http://www.sciencebusiness.net/news/75940/Why-we-need-a-new-strategy-for-health-research-in-Europe. Accessed 21 Jan 2014
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WHY INCENTIVISE THE INNOVATORS? A CASE STUDY
39
Celebration of Science. www.celebrationofscience.org/about. Accessed 10 Sept 2012
$3.8 billion US investment in the Human Genome Project
1990 2003 ROI on Human Genome Project: $796 billion 310,000 jobs
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Medical innovation is turning knowledge about disease mechanisms at the genetic and cellular level into products that cure or prevent illness. Medical innovation in particular brings about a virtuous cycle of better health, longer life and greater prosperity that in turn stimulates additional investment in even more advanced innovations for preventing and treating disease.
40
4
THE VIRTUOUS CYCLE OF INNOVATION & HOW TO SUSTAIN IT MEDICAL INNOVATION IS THE BEST HOPE OF LONGER LIFE AND BETTER HEALTH FOR ALL.
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All too often, health is still primarily perceived as a cost, a drain, a burden – and not as an
investment for the future which can pay great dividends. “ “
Tonio Borg, European Commissioner for Health and Consumer Policy
http://ec.europa.eu/commission_2010-2014/borg/docs/04092013_speech_futur_public_health_en.pdf. Accessed 21 Jan 2014
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INNOVATION REQUIRES INVESTMENT, WHICH LEADS TO FURTHER INNOVATION
42
Investment Innovation results from continuous
investment by both public and private actors, including biopharmaceutical
companies such as Celgene
Innovation Celgene has a proven track record of delivering better outcomes with
better healthcare through innovation
Access Access and reimbursement
for current innovative therapies fund investment in future innovation
Commitment The unprecedented survival results reported with Celgene’s innovative therapies are direct results of the
company’s commitment to improving the lives of patients worldwide
Virtuous Cycle of Innovation
Improvements in healthcare are an
important source of gains in health, longevity and productivity globally
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MEDICAL INNOVATION IS A SELF-SUSTAINING PROPOSITION
43
Drug Discovery and Development: Understanding the R&D Process. Congressional Budget Office, Research and Development in the Pharmaceutical Industry, 2006. www.innovation.org. Accessed 15 Nov 2012
Clinical trials
5 Compounds
IND
SU
BM
ITTE
D
Indefinite 10 – 12 Years
Pre- discovery
FDA Review & Scale-
up to Mfg.
0.5 – 2 Years
3 – 6 Years
~5,000 – 10,000
Compounds
ND
A S
UB
MIT
TED
PHASE I II III
Number of volunteers
20- 100-501,000-5, 100 0 000
6 – 7 Years
Preclinical
Developing a new medicine takes an average of 10–15 years; the Congressional Budget Office reports that “relatively few drugs survive the clinical trial process.” Innovative therapies have a limited time in their lifecycle to recapture
investment and fund future innovation Discovery & development Innovator exclusivity Generic
One FDA- Approved Therapy
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MAXIMIZING THE PROMISE OF SCIENCE: 5,000+ MEDICINES IN DEVELOPMENT IN 2011
44
454 Musculoskeletal
Diseases
1,247 Neurological
disorders
650 Cardiovascular
disorders 412
Diabetes mellitus
204 HIV/AIDS
and related conditions
69 Liver disease and related conditions
1,586 Infectious diseases
1,795 Rare diseases
731 Immunological
conditions
3,436 Cancer
142 Lung cancer 95 Breast cancer
383 Blood cancers 63 Colorectal cancer
105 Skin cancer
Reflects compounds in all phases of development, including having been filed with the FDA, or approved by the FDA, but not yet on the market in the U.S. as of January 2013. Medicines with multiple indications may appear in more than one category, but in the total number (5,000+ medicines), only the initial indication is counted. PhRMA. Innovation in the Biopharmaceutical Pipeline. http://phrma.org/sites/default/files/pdf/2013innovationinthebiopharmaceuticalpipeline-analysisgroupfinal.pdf. Accessed 21 Jan 2014
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ORPHAN DRUG REGULATION HAS A CRITICAL IMPACT
45
ON THE VIRTUOUS CYCLE OF INNOVATION IN EUROPE
Office of Health Economics. Assessment of the Impact of OMPs on the European Economy and Society. Report November 2010. http://www.ohe.org/publications/article/assessment-of-the-impact-of- orphan-medicinal-products-on-europe-15.cfm. Accessed 13 Dec 2012
The Orphan Drug Regulation (EC) 141/2000, together with national incentives, have contributed to the discovery and development of much needed treatments. Orphan drug expenditures are expected to
account for less than 5% of total European pharmaceutical expenditures by 2020, confirming both the affordability of orphan drugs and the sustainability of this new model for healthcare systems
8
68 80 70
60
50
40
30
20
10
0
165
480
0
100
200
300
400
500
600
Pre-Orphan Drug Legislation (2000)
Post-Orphan Drug Legislation (2010) 2000 2008
Drugs for rare diseases receiving marketing authorization in Europe
European investment in orphan drug R&D, 2000 and 2008
Num
ber o
f Dru
gs A
vaila
ble
Mill
ions
€
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IT TAKES 12 YEARS OR LONGER TO BRING A NEW TREATMENT TO PATIENTS
46
The drug development pyramid
1
2
2-5
5-10
10-20 Substances
10,000-30,000 Substances
Synthesis, Examination &
Screening
Preclinical Tests
(Animal)
Clinical Tests (Human)
Product surveillance Phase IV
Phase III
Phase II
Phase I
Basic Research
Development
Introduction Registration
PHARM R&D
Years 12 11 10 9 8 7 6 5 4 3 2 1 0
Briggs. Effective Use of Health Technology Assessment to Maximize Market Access. http://www.iconplc.com/icon-files/insight-newsletter/June11/effective.html. Accessed 16 Nov 2012
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Vernon et al. Health Econ. 2010 Aug;19(8):1002-5
EVEN AFTER APPROVAL, FEW MEDICINES RECOVER THEIR R&D COSTS
New medicines introduced between 1990 and 1994, grouped by tenths, by lifetime sales
2000
1500
1000 %
Just 2 in10 approved medicines produce revenues
that exceed average R&D costs
After-tax average R&D costs
500
0
1 2 3 4 5 6 7 8 9 10 Note: Prescription drug development costs represent after-tax out-of-pocket costs in 2000 dollars for drugs introduced from 1990–94. The same analysis found that the total cost of developing a new drug was $1.3 billion in 2006. Average R&D costs
include the cost of the approved medicines as well as those that fail to reach approval.
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DEVELOPING NEW CANCER THERAPIES TAKES EVEN LONGER, WITH LOWER SUCCESS RATES
48
65
35
64
83
64
28
45
82
10
0
40
30
20
70
60
50
90
80
Phase l to Phase ll Phase ll to Phase lll Phase lll to NDA/BLA NDA/BLA to Approval
Succ
ess
rate
s
Non-Oncology 2011 Oncology 2011
BIOtech Now. Oncology Clinical Trials – Secrets of Success. http://www.biotech-now.org/business-and-investments/2012/02/oncology-clinical-trials-secrets-of-success. Accessed 15 Nov 2012
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WORTH THE INVESTMENT: MORE PEOPLE ARE SURVIVING AS MORE NEW THERAPIES ARE DEVELOPED (US DATA)
49
1980 1990 2000 2010
4.57
9.5 11.7
43
129 140
120
100
0
60
40
20 15
14
12
10
0
6
4
2
Cumulative number of new cancer therapies
Cancer survivors
80 85 8 6.6
Number of cancer
therapies Millions of people
National Cancer Institute, Surveillance Epidemiology and End Results (SEER). http://seer.cancer.gov/csr/1975_2009_pops09/index.html. Accessed 31 Oct 2012 U.S. Food and Drug Administration’s Drug Approval Database. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm. Accessed 16 Nov 2012
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THE GENERICS MARKET IS PART OF THE VIRTUOUS CYCLE AND DEPENDS ON INNOVATION
Share of generics in the total pharmaceutical market, 2011 (or nearest year)
50
OECD Health Statistics. http://dx.doi.org/10.1787/health-data-en. Accessed 21 Jan 2014
35
28 24
44
36
17 15 18 17 15
23
12 16
9 8 3
76 75 72 70
51
42 36 35 34 34
30 25
21 18 16
9
100 90 80 70 60 50 40 30 20 10
0
%
1 Reimbursed pharmaceutical market.
Value Volume
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Philipson et al. Health Affairs 2012; 31:4. http://imgsrv.wben.com/image/wben2/UserFiles/File/Philipson%20FF.pdf. Accessed 21 Jan 2014
PUBLIC POLICIES CAN HAVE DIRECT CONSEQUENCES FOR CANCER PATIENTS
USA EUROPE
Average survival of patients diagnosed with cancer
11.1 years Average survival of patients
diagnosed with cancer
9.3 years
Differences in US costs reflect more rapid uptake of new technologies that may lead to difference in survival. “
“ THE COST OF THE CURE: EXPLODING THE MYTHS
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CELGENE IS COMMITTED TO THE VIRTUOUS CYCLE OF INNOVATION IN EUROPE
Over half our clinical trial sites and patients in Celgene’s global programme established in Europe
• We have been conducting clinical trials in Europe since 2004, two thirds of which are still ongoing
• More than 5,000 patients have benefited from innovative treatments in the framework of our clinical research in 27 countries across Europe
52
1 -100
101 - 400
401 - 800
801 +
Number of patients enrolled in CTs
European countries with patients enrolled in Celgene clinical trials since 2004
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CELGENE: DELIVERING ON ITS PROMISE OF
53
BRINGING NEW TREATMENTS TO PATIENTS IN NEED
The products represented as in development and found in the product pipeline are intended for investors and members of the media to provide general information on Celgene. This information is not represented to be a complete description and is subject to change without notice. Celgene Corporation may from time to time update this information but does not warrant that will take place at any particular time nor assume any obligation to update this information
0
200
400
600
800
1000
1200
1400
2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Celgene R&D investment in millions of dollars non-GAAP
Celgene’s has already developed innovative therapies that bring tremendous benefits to providers, patients and healthcare systems worldwide:
Reducing hospitalisations
Preventing disability
Eliminating surgeries
Improving quality of life
Extending survival
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260
225
180 170
120 120
75
55 55
25 25 20 10
0
50
100
150
200
250
300
54
Based on Kantar Health’s CancerMPact® epidemiology database for the US, EU5 and Japan. 2011
CELGENE RESEARCH SPANS BROAD RANGE OF HAEMATOLOGICAL MALIGNANCIES
Most prevalent haematologic cancers
US,
EU
-5, J
apan
Pre
vale
nce
(000
s)
Celgene Studies: Active/Planned Currently, No Active Programs
250,000 People will die this year from haematologic cancers that are considered orphan diseases
DLBC CLL MDS ALL AML CML Hodgkin Lymphoma
MCL PTCL Myelofibrosis CTCL Follicular Myeloma
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CELGENE’S LEADING HAEMATOLOGY PIPELINE
55
HAEMATOLOGY EU Regulatory Pre-clinical Phase I Phase II Phase III Filing & Approval
MULTIPLE MYELOMA (MM) Relapsed/Refractory MM
Relapsed/Refractory MM
Newly diagnosed MM
Newly diagnosed MM
Maintenance MM
MYELODYSPLASTIC SYNDROMES (MDS) MDS Deletion 5q
Non-deletion 5q
Lower-risk MDS
ACUTE MYELOID LEUKEMIA (AML) AML (20%-30% blasts)
AML (>30% blasts)
Post-induction AML Maintenance
Combination Therapy for AML
MYELOFIBROSIS Myelofibrosis
The products represented as in development and found in the product pipeline are intended for investors and members of the media to provide general information on Celgene. This information is not represented to be a complete description and is subject to change without notice. Celgene Corporation may from time to time update this information but does not warrant that will take place at any particular time nor assume any obligation to update this information
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CELGENE’S LEADING HAEMATOLOGY PIPELINE (continued)
56
HAEMATOLOGY EU Regulatory Pre-clinical Phase I Phase II Phase III Filing & Approval
LYMPHOMA
Relapsed/Refractory Peripheral T-cell Lymphoma
Maintenance Diffuse Large B-cell Follicular Lymphoma
First-line Peripheral T-cell Lymphoma
Relapsed/Refractory Mantle Cell Lymphoma
Relapsed/Refractory Diffuse Large B-cell
CHRONIC LYMPHOCYTIC LEUKAEMIA (CLL) First-line CLL
Maintenance CLL
CLL Btk Inhibitor
ANAEMIAS
Renal Anaemia with Metabolic Bone Disease
Diamond Blackfan Anaemia
Beta-thalassaemia
MDS
Beta-thalassaemia
MDS The products represented as in development and found in the product pipeline are intended for investors and members of the media to provide general information on Celgene. This information is not represented to be a complete description and is subject to change without notice. Celgene Corporation may from time to time update this information but does not warrant that will take place at any particular time nor assume any obligation to update this information
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CELGENE’S EXPANDING ONCOLOGY PIPELINE
57
ONCOLOGY EU Regulatory
Pre-clinical Phase I Phase II Phase III Filing & Approval
Metastatic Breast
First-line Advanced Pancreatic
First-line Advanced Non-small Cell Lung
First-line Metastatic Melanoma Relapsed/
Refractory Small Cell Lung Cancer
First-line Metastatic Breast
Dual TORK Inhibitor
Nucleoside Analogue
Dual TORK/DNA PK Inhibitor
Pleiotropic Pathway Modulator
The products represented as in development and found in the product pipeline are intended for investors and members of the media to provide general information on Celgene. This information is not represented to be a complete description and is subject to change without notice. Celgene Corporation may from time to time update this information but does not warrant that will take place at any particular time nor assume any obligation to update this information
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CELGENE’S INFLAMMATION AND IMMUNOLOGY
58
Psoriasis
Psoriatic Arthritis
Ankylosing Spondylitis
Behçet’s Disease
Rheumatoid Arthritis
Crohn’s Disease Cutaneous Lupus Erythematosus
Systemic Sclerosis
EMERGING PRODUCT PIPELINE INFLAMMATION & IMMUNOLOGY
EU Regulatory Pre-clinical Phase I Phase II Phase III Filing & Approval
The products represented as in development and found in the product pipeline are intended for investors and members of the media to provide general information on Celgene. This information is not represented to be a complete description and is subject to change without notice. Celgene Corporation may from time to time update this information but does not warrant that will take place at any particular time nor assume any obligation to update this information
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WE ARE AT A CRITICAL CROSSROADS FOR MEDICAL INNOVATION
59
A
MAJOR PARADOX The potential of science is
greater than ever …
But the outlook for investment has never been more
uncertain
R&D investment = longer, better, healthier lives
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WHAT’S AT STAKE…
60
Today’s investments in healthcare and R&D can create a world free from cancer for our children and our children’s children
OFFER HOPE
2 3
GENE MAPPING
CELLULAR THERAPIES
GENE THERAPY
IMMUNOMODULATORS
PERSONALISED MEDICINE
NANOTECHNOLOGY EPIGENETICS
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The best way to predict the future is to invent it “ “
Alan Kay, Computer Scientist
Remark taken from Kay's address before the 20th annual meeting of the Stanford Computer Forum
THE COST OF THE CURE: EXPLODING THE MYTHS
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Celgene International Sàrl Route de Perreux 1, 2017 Boudry Switzerland
Date of preparation: January 2014