The Product Development Roadmap

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The Product Development Roadmap
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Expenditures(million)
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Biopharmaceutical Attrition Continues
SourcePhrma 2005 Profile
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The Value Ladder Developing Biotech Products
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Calculated Value of a Hypothetical New Drug at
Various Stages of Drug Development by DCF Model
Development Phase Successful Rates Cumulative Probability
Early Pre-clinical Late 50 4
Pre-Clinical (IND) 40 8
Phase I 73 19
Phase II 45 27
Phase III 73 59
NDA 81 81
Market 100 100
SourceMorgan Stanley Research, 10/15/02
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Drug Discovery
Drug Development
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Clinical Trial (??????)
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NDA
IND
Phase I Phase II Phase III
Target Validated Target Lead
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CMO
BPO
BPO??????(Business Process Outsourcing)
???????? ITIS????
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????
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Biotech Index(BTK) outperforms NASDAQ DJIA for
the past decade
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Significant capital flows into biotech/medical
device sectors since 2000
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WORLDWIDE GLOBAL PHARMACEUTICAL SALES
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??????
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Burrill Public Biotech Companies 2001 to 20061
(billions)
2001 2002 2003 2004 2005 2006 CHANGE 2005-2006
Sales/Revenue 39.0 42.7 47.4 59.5 71.5 82.6 15.5
RD Expense 12.3 13.5 14.3 16.8 18.5 21.7 17.3
Net Income (loss) (4.7) (11.6) (4.1) (4.4) (4.1) (3.2) 21.0
Cash Equivalents 2 45.3 41.9 41.6 45.5 47.7 51.4 7.7
Market Capitalization 382 224 344 400 490 492 0.4
Number of Companies 356 329 315 356 363 360 -0.8
1 Includes ADRs 2 Includes marketable
securities Source Burrill Company
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• The mapping of the human genome and advances
  that make it faster and easier to screen
  potential drug candidates Should be lighting a
  fire under drug development, but they havent so
  far.
• July 30, 2007. Business Week

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???(Generics)???????(Biosimilar/ Follow-on
Biologics)??
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????????
?? ?? ????? 2005???? ????
Pfizer Zoloft ??? 33 2006
Pfizer Norvasc ??? 47 2007
Pfizer Zithromax and Zmax ???? 20 2006
Pfizer Lipitor ???? 130 2010
Pfizer Zyrtec/Cirrus ????? 23 2007
Merck Co. Zocor ???? 44 2006
Merck Co. Fosamax ????? 32 2008
Astra-Zeneca Nexium ??? 46 2005
Astra-Zeneca Toprol-XL/Seloken ??? 17 2007
Eli Lilly Zyprexa ????? 42 2011
Glaxo-Smith Kline Flonase/Flixonase ????? 12 2006
Glaxo-Smith Kline Coreg ??? 10 2007
Glaxo-Smith Kline Advair/Seretide ?? 55 2008
Glaxo-Smith Kline Lamictal ?? 15 2008
Glaxo-Smith Kline Lmitrex/Imigran ??? 13 2008
Bristol-Myers Squibb Pravachol ???? 23 2006
Bristol-Myers Squibb Plavix/Iscover ????? 63 2011
Novartis Lotrel ??? 11 2007
Sanofi-Aventis Ambien/Stilnox ?? 19 2006
Sanofi-Aventis Lovenox/Clexane ?? 27 2006
Sanofi-Aventis Allegra/Telfast ????? 17 2006

????
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?????????????????
???? ???? ??(????) ?????
1.Ceredase Genzyme - 2001
2.Cerezyme Genzyme - 2001
3.Intron A(Interferone a-2b) Schering-Plough 9.0 2002
4.Humulin(insulin) Eli Lilly 6.3 2002
5.Nutropin(Somatropin) Genentech - 2003
6.Avonex(Interferone a-2b) Biogen 15.0 2003
7.Epogen(Epoetin-?) Amgen 30.0 2004
8.Geref(Sermorelin) Serono - 2004
9.Synagis Abbott - 2004
10.Activase(Alterplase) Genentech - 2005
11.Protropin(Somatrem) Genentech - 2005
12.Neupogen(Filgrastim) Amgen 35.0 2006
?? 95.3
????Datamonitor ???IED/IT IS????(2006/10)
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• 1.??????????1070????(2006?),??????????270??(25)
  ,?????800??(75)?
• 2.????????????,?????163?,??270?????
• 3.????????????????70????,???35??????1/3???????,
  ??????25?

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2002-2015??????????????
2004?????????????10, ??2015??????????15.
????IMS Health
25
??????????

1. ??????????
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26
??????????(?)
????????????????????????????????????????????????
?????????????,??????????Fortune
1000,????????? ??????600??????????????,?????????
??????????2020?,???????,??????????
27
Innovation GAP Getting Wider
New Drug Approvals (NMEs)
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The innovation gap Biotech and big pharma RD
expenditures and new molecular entity approvals
SourceErnst Young
29
??????????(?)
????????(CRO)????,???????,??????????????????,???C
RO???????
30
??????????????
?? ???? ??????? ???????? ???????? ???????
1 Sanofi-Aventis 205 139 66 32.2
2 GlaxoSmithKline 181 123 58 32.0
3 Merck Co 158 119 39 24.7
4 Hoffmann-La Roche 145 72 73 50.3
5 Novartis 123 66 57 46.3
6 Johnson Johnson 116 65 51 44.0
7 Pfizer 111 69 42 37.8
8 AstraZeneca 108 81 27 25.0
9 Astellas 87 51 36 41.4
10 Bristol-Myers Squibb 81 50 31 38.3
?? 1,315 835 480 36.5
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Partnerships between Biotech and big Pharma

• 4050 of pharmaceutical products come from
  licensing MA in 2000.
• More than 65 of pharmaceutical products will
  result from external RD deals, licensing MA
  in 2010.

32
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????????????????????????????(??????????????),????
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• More than 70 big drugs will lose their patent
  protection by 2011, causing a collective loss of
  100 billion in annual sales.
• July 30, 2007, Business Week

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??????????(?)
??/????, ???????????(Nutraceuticals)??????????(P
seudo science)??????,????????,???????????????????
?,???Nutraceuticals?????????
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Global Nutraceuticals Industry Hits 210 Billion
and Then Some
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Skin Care Market

• Skin care is a growth market
• Growth drivers
• Nearly 40 of the US population isolder than 45
• Trends toward prevention and self-care
• Key products
• Anti-aging
• Cleansers
• Moisturizers
• Sun care
• Hand and body lotion

Source Packaged Facts, 2005
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??
42
??????????(?)
??????????????Pharmacogenomics??????????????????(
Personalized, information-based
approach)???????????? ?Theranostic
era?(??/?????????)????,???????????????
43
Todays medicine challenge One size doesnt fit
all
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?????????
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????(????)
???(??????)
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Pharmacogenomics
???????????????
Genomics-Based
?????
rDNA
???????
Synthetics
Natural Products
1900-1940 1940-1970 1970-1990
1990-2010 2010-
????IMS Health?Deutsche Bank????ITIS????
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The Promise of Personalized Medicine
ACCORDING TO ITS CHAMPIONS, PERSONALIZED MEDICINE CAN
detect disease at an earlier stage, when it is easier to treat effectively
enable the selection of optimal therapy
reduce trial-and-error prescribing
increase patient compliance with therapy
improve the selection of targets for drug discovery
reduce the time, cost and failure rate of clinical trials
generate attractive returns without blockbuster-size sales
revive drugs that failed clinical trials or were withdrawn from the market
reduce development costs (due to shorter time to discovery)
avoid withdrawal of marketed drugs
reduce adverse drug reactions
shift the emphasis in medicine from reaction to prevention
Reduce the overall cost of healthcare
Source Personalized Medicine Coalitions The
Case for Personalized Medicine Burrill Company
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Selected Targeted Treatments
Selected Targeted Treatments
Personalized cancer vaccines (Favrille/Genitope)
Gleevec(Novartis)--pH CML kinase inhibitor
Iressa(Astrazeneca)--EGFR tyrosine kinase inhibitor
Tarceva(Genentech/OSI)--HERI/EGFR inhibitor
Erbitux(ImClone/BMS)--HERI/EGFR inhibitor
Avastin(Genentech)--VEGF/VEGFR inhibitor
Herceptin(Genentech)--HER2 inhibitor
BilDil(NitroMed)- heart failure in African American patients
Velcade(Millennium)--proteasome inhibitor
Other Semi-Targeted Treatments(approved or late-stage trials)
Nexavar(Bayer/Onyx)--multikinase inhibitor
Tykerb(GSK)--ErbB-2/EGFR inhibitor
Enzastaurin(Lilly)fflPKC-Beta,AKT/PI3 inhibitor
47
??????????(?)
??????,???????????????????????????????? ??????
?????????
48
Drugs and Healthcare cost increases with age
49
Projected Alzheimers Disease Prevalence, 2000 to
2100
PhRMA projections calculated by applying current
prevalence rates to population projections. Source
US Census Bureau Hebert et al
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Medicines in Development for Older Americans
Some medicines are listed in moe than one
category Source PhRMA
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Big new markets

• Obesity/diabetes/metabolic disease
• Alzheimers/memory
• Anti-aging
• Anti infectives (antibiotic resistance)
• Wellness (preventative/predictive cure)

52
Feel Good/Feel Better Drugs
Product For Company
Lipitor Lowers Cholesterol Pfizer
Propecia Male Pattern Baldness Merck
Renova Wrinkle Remover JNJ
Celebra Arthritis Pain Pfizer
Sonata Insomnia Wyeth
Evista Osteoporosis Eli Lilly
Detrol Incontinence Pfizer
Viagra Male Impotence Pfizer
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??????????(?)
???????????????? 1.????????(????) 2.????????
???? 3.???????????? 4.Drugs-devices-genes
??????? ???????????????????,????????????-???-???
?????,???? 1.???(stem cells)????? 2.RNAi(RNA
interferenee)????? 3. ?
54
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55
NANOTECH
56
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57
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58
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59
Thank you !????
60
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US 12M
510M
gt50M
gt500M
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CRO??
CMO??
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61
??????????????
(1)??(????) (2)??(US-FDA,??-???,??-???,??-SFDA)
(Pre-IND,IND(Phase, I, II, III)NDA) (3)???(??,
Know-how,??,etc.) (4)??(R?D?P) (5)??
(1)(2)(3)(4)(5)???(??)?Leadership ??
?? ??