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Challenges and Opportunities for Growth and
Innovation in Pharmaceuticals and
Biotechnology

Colorado’s Bioscience Community: Building on the Foundation
August 28, 2007




David K. Rosen, D.V.M.
Head, Development and
Commercial Strategic Alliances
Pfizer Inc
Pfizer is an Innovative, Global Research-
Based Health Care Company


    Products       Category
                  Lipid-Lowering
                  Hypertension/Angina
                  Arthritis
                  Depression/Anxiety
                  Antibiotic
                  Erectile Dysfunction
    Lyrica        Fibromyalgia
                  Antifungal




                                            2
Therapeutic Area Strategy
    How it Works in Pfizer

PURSUE AGGRESSIVELY – Increase investment to ensure success
 Risk: Multiple shots on goal to offset risk
 Speed: Invest for speed




STANDARD – Current Pfizer approach to drug development


ALTRUISTIC – Targeted investment to address social need


STAGED INVESTMENT
 Technical Doability: Develop the science
 Commercial Doability: More market research to understand the opportunity




MONITOR – Do not invest until technical or commercial opportunity clarifies

EXIT – No further investment in this area
                                                                              3
Pharmaceutical Industry
      Challenges




                          4
Pfizer Conducts R&D Globally




                                   Cambridge,
                                      MA
                                                Sandwich,
La Jolla, CA                                    ENGLAND

               St. Louis,   New London                      Exiting:
                  MO        & Groton,CT
                                                            •Kalamazoo, MI
                                                            •Ann Arbor, MI
                                                            •Nagoya , Japan   5
Shrinking Market Exclusivity

 Innovative Drug /                                                                  2nd Generation
  Year Introduced                                                                     Drug/Year


       Inderal - 1965                                                               Lopressor - 1978
      Tagamet - 1977                                                                Zantac - 1983
      Capoten - 1980                                                                Vasotec - 1985
      Seldane - 1985                                                                Hismanal – 1989
          AZT - 1987                                                                Videx – 1991
      Mevacor - 1987                                                                Pravachol – 1991
       Prozac - 1988                                                                Zoloft – 1992
      Diflucan - 1990                                                               Sporonox – 1992
  Recombinate - 1992                                                                Kogenate – 1992
     Celebrex - 1999                                                                Vioxx– 1999

                        0   1   2     3    4      5    6     7     8       9   10

                                Years of Exclusivity for Innovative Drug

                                                                                                       6
High Attrition Rate in Drug Development

          Thousands of
       Compounds Screened
                                                 ~100 Discovery Approaches
                                                                   High Risk Process
            Preclinical
           Pharmacology              ~250                     12-15 years, ~$1 B/candidate

            Preclinical Safety
                                                    ~5                                     1 –2
                                                                                         Products
                        Clinical Pharmacology
                               & Safety



          Discovery                  Exploratory Development                  Full Development
                                      Phase I      Phase II              Phase III




 0                               5                                  10                              15

Idea                                      11 - 15 Years                                          Drug
                                                                                                    7
Expanding the Scope of R&D
                                Future Biologics Powerhouse


                                                                                (pegvisomant for injection)             human insulin powder
         (interferon beta-1a)    (dalteparin sodium injection)




                                            PEG-hGH                   CTLA4 mAb                   MCSF mAb

                                                        ETC-588        TLR CPG 7909                           ETC-216

                                             T2-TrpRS               IGF1R mAb                 ETC-642
                                                                 CD40 mAb   MAdCAM mAb


                                                       $1.5 Billion Pfizer
                                                      2006 Biologics Sales
                                                                                                                                        8
NY 7/31/2006
Non-Invasive Protein Delivery

   Exubera®: The first inhaled
    insulin
   A breakthrough in
    diabetes treatment




                                        9
Biomarkers, Diagnostics and Devices

   Pfizer is interested seeing these biomarkers,
    diagnostics and devices developed and
    commercialized but our role is enabling
   Our interest is in access to the technology for
    R&D; results and data
   How will we use these technologies?
       Designing medicines
       Monitoring disease
       Identifying patients who will respond to a medicine
       Identifying patients who might respond adversely
        to a medicine


                                                              10
Data Management

   Our needs extend beyond what would
    traditionally be seen or considered as science
       Applications like medical records are obvious
   What else do we need to do or want to do with
    this data?
       Data acquisition
       Data mining
       Data analysis
       Data exchange and meta-analysis
        –   clinical trials
        –   diagnostics and genetic testing

                                                        11
Precompetitive and Competitive Technologies
      an Alzheimer’s Disease Example


   Precompetitive Technology:
      We all need better (more accurate at an earlier stage of
       disease), faster, less expensive ways to diagnose AD
      Help us enroll patients in clinical trials with confirmed
       AD
      Determine if drug was having impact on disease
       progression
      Fund as a consortium?

   Competitive Technology
      An AD diagnostic customized for our compound which
       would allow us to compare how our drug is impacting
       the patient as compared with similar therapies
      Fund on our own


                                                                   12
Productivity Challenge

      $40

      $35
                                 Total R&D Investment ($Billions)
      $30

      $25

      $20

      $15

      $10

       $5

       $0




                                                                           2005
                                                                    2000
                                              1985




                                                     1990




                                                             1995
            1970




                          1975




                                      1980




                                                                                  13
Source: 2006 PhRMA Annual Survey
Total BioPharmaceutical R&D Spending 2005-2006
                                                                               ($Billions)

      $55                                 Total spending increased by $3.4 B                 Biotech
      $50                                         From 2005 to 2006                           20%
      $45

      $40

      $35

      $30

      $25
                                                                                             Pharma
      $20                                                                                     80%
      $15

      $10

       $5

       $0




                                                                                      2005
                                                                  1995




                                                                           2000
            1970




                                                1985




                                                         1990
                          1975




                                   1980




                                                                                               14
Source: 2006 PhRMA Annual Survey
Staying Competitive in a Changing Global
Environment: Pfizer’s evolving strategy


    Technical expertise is available around the globe
        India has chemistry innovation
        China has chemistry innovation and clinical trial
         capacity
        South Korea has advanced data collection and
         transmission, patient monitoring and clinical trial
         capacity and implementation
        All of these countries have scientific and technical
         experts educated in the west and trained at the top
         20 pharmaceutical companies in the west



                                                                15
Opportunities for Growth
    and Innovation
We are one of the leading source of Biotech funding

         Industry leading investment in R&D

                                                       $7.7
                                                              $7.5 $7.5
                                                $7.1                         Total Strategic Alliances
                                                                              Spending: >$1.4B in the last 4
  ($Billions)                                                                 years
                                         $5.2
                                  $4.8
                           $4.4
                                                                             “Pfizer…the largest source of
                                                                              discovery stage biotech capital”
                                                                              Source: In Vivo, September 2004
               $2.3 $2.3
        $1.8
 $1.6




1996        1998        2000         2002          2004          2006

Source: Pfizer Annual Report                                                                                    17
Extensive External Reach
   2006: Over 1800 business transactions/ >800 collaborations
   Global organization of 56 people at 6 sites in
    US/EU/AustralAsia - predominantly scientific expertise
    with enhancements:
       Finance, Business, Law, Medicine, Marketing/Sales, M&A
       Global colleague interaction allows synergistic expertise
   Strategic Alliances presently covers all areas of Research
    and Development including deals/technologies that
    interface with Manufacturing, Veterinary Medicine, PGP,
    and Consumer Health Care


                                                                    18
Agreement Types


   Non-disclosure agreement
   Material transfer agreement
   License to patent/intellectual property
   Research collaboration
   Corporate collaboration (major deal)
   Consultantship
   Fee for service (outsourcing contracts)
   Acquisition of new chemical entities
                                              19
Alliance Types
   Research – Genes, Leads, Targets, Technology (Scripps)
   Candidate Producing (Kosan, ICAgen)
   In-Licensing – Early & Late Stage (Renovis, TransTech)
   Out-licensing – Assets, IP, Patents, Niche products (Darafenicin)
   Joint Venture – Marketing for Products (Insulin production)
   Co-promotion Deals – Risk & Reward (Rebif)
   M&A – Pipeline, Resources, Financial, Strategic (Rinat, Powdermed)




                                                                        20
Pfizer Global Research and Development
 Major Alliance Partnerships: March 2006

                                                            Speeding/Enhancing
                  Altering the R&D                                                                   Enhancing
                                                               Development
                Productivity Paradigm                                                               Pipeline Value
                                                                Candidates

                                                                                                               Product
   Gene           Function        Screen          Lead      Candidate         Development         Speed      Enhancement



Athersys         Affymetrix     Biotrove        Amgen       Neurion          Amersham          U. Michigan   Alza
Chondrogene      Deltagen       Evotec          Cerep       Vicuron (acqu)   U. Cambridge      ProModel      Atrix (QTL)
Metabolex        InPharmatica   Stem Cell Sci   Entelos     Wake Forest      Curagen           Genestruct    Ventaira
Karolinska       Xenogen        U. Dundee       Spotfire    Monogram         GeneLogic         Codexis       Bend
U. Pittsburgh    Lexicon Gen    Xenoport        Medarex     Rigel            Lonza             Perlegen      Nektar
Wash. U          Chondrogene    Lilly           Morphosys   Nicox            Meridica (acq)    Lifespan      Freie Univ.
                 Cerep          ActivX          Quorex      Angiosyn         Kings Pain Ctr    Genizon       U. Rochester
                 Perlegen/NIH   Sangamo         Isis        Idun (acqu)      NIA                             Oxford
                 Scripps        Odyssey Th.     TRansTech   Coley            Virtual Scopics                  Biosensors
                                                Archimex    Renovis          Yale
                                                            Noxxon           Symyx
                                                            GeneLogic        Boehringer
                                                                              Ingelheim
                                                                             Chromos
                                                                             iCardiac
                                                                                                                     21
How will Pfizer Invest in New Technologies in
     2007 and Beyond?

Strategic themes for SA investments
     Productivity
      CAN producing alliances
      TA Enablers- focused alliances
      Emerging science/technologies investments


    Leveraging Scale
     Cross-line technology investments
     Technologies enhancing Speed/Efficiency/Process


                                     Flexible Budget

                                   Emerging Sciences

 Periodic review of where    SPEED/Efficiency/Process

                                      TAPT Enablers
     we are investing
                             CAN-producing alliances

                                                        22
Investing In The Future


              Gene Therapy
              Therapeutic Vaccines
              Biomarkers, Diagnostics and Personalized
               Medicine
              Data Management
              Pfizer’s Incubator



                                                          23
NY 7/31/2006
Pfizer Strategic Alliances


       Thank you


                             24

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D K R Colorado B I O 07 Final

  • 1. Challenges and Opportunities for Growth and Innovation in Pharmaceuticals and Biotechnology Colorado’s Bioscience Community: Building on the Foundation August 28, 2007 David K. Rosen, D.V.M. Head, Development and Commercial Strategic Alliances Pfizer Inc
  • 2. Pfizer is an Innovative, Global Research- Based Health Care Company Products Category Lipid-Lowering Hypertension/Angina Arthritis Depression/Anxiety Antibiotic Erectile Dysfunction Lyrica Fibromyalgia Antifungal 2
  • 3. Therapeutic Area Strategy How it Works in Pfizer PURSUE AGGRESSIVELY – Increase investment to ensure success  Risk: Multiple shots on goal to offset risk  Speed: Invest for speed STANDARD – Current Pfizer approach to drug development ALTRUISTIC – Targeted investment to address social need STAGED INVESTMENT  Technical Doability: Develop the science  Commercial Doability: More market research to understand the opportunity MONITOR – Do not invest until technical or commercial opportunity clarifies EXIT – No further investment in this area 3
  • 4. Pharmaceutical Industry Challenges 4
  • 5. Pfizer Conducts R&D Globally Cambridge, MA Sandwich, La Jolla, CA ENGLAND St. Louis, New London Exiting: MO & Groton,CT •Kalamazoo, MI •Ann Arbor, MI •Nagoya , Japan 5
  • 6. Shrinking Market Exclusivity Innovative Drug / 2nd Generation Year Introduced Drug/Year Inderal - 1965 Lopressor - 1978 Tagamet - 1977 Zantac - 1983 Capoten - 1980 Vasotec - 1985 Seldane - 1985 Hismanal – 1989 AZT - 1987 Videx – 1991 Mevacor - 1987 Pravachol – 1991 Prozac - 1988 Zoloft – 1992 Diflucan - 1990 Sporonox – 1992 Recombinate - 1992 Kogenate – 1992 Celebrex - 1999 Vioxx– 1999 0 1 2 3 4 5 6 7 8 9 10 Years of Exclusivity for Innovative Drug 6
  • 7. High Attrition Rate in Drug Development Thousands of Compounds Screened ~100 Discovery Approaches High Risk Process Preclinical Pharmacology ~250 12-15 years, ~$1 B/candidate Preclinical Safety ~5 1 –2 Products Clinical Pharmacology & Safety Discovery Exploratory Development Full Development Phase I Phase II Phase III 0 5 10 15 Idea 11 - 15 Years Drug 7
  • 8. Expanding the Scope of R&D Future Biologics Powerhouse (pegvisomant for injection) human insulin powder (interferon beta-1a) (dalteparin sodium injection) PEG-hGH CTLA4 mAb MCSF mAb ETC-588 TLR CPG 7909 ETC-216 T2-TrpRS IGF1R mAb ETC-642 CD40 mAb MAdCAM mAb $1.5 Billion Pfizer 2006 Biologics Sales 8 NY 7/31/2006
  • 9. Non-Invasive Protein Delivery  Exubera®: The first inhaled insulin  A breakthrough in diabetes treatment 9
  • 10. Biomarkers, Diagnostics and Devices  Pfizer is interested seeing these biomarkers, diagnostics and devices developed and commercialized but our role is enabling  Our interest is in access to the technology for R&D; results and data  How will we use these technologies?  Designing medicines  Monitoring disease  Identifying patients who will respond to a medicine  Identifying patients who might respond adversely to a medicine 10
  • 11. Data Management  Our needs extend beyond what would traditionally be seen or considered as science  Applications like medical records are obvious  What else do we need to do or want to do with this data?  Data acquisition  Data mining  Data analysis  Data exchange and meta-analysis – clinical trials – diagnostics and genetic testing 11
  • 12. Precompetitive and Competitive Technologies an Alzheimer’s Disease Example  Precompetitive Technology:  We all need better (more accurate at an earlier stage of disease), faster, less expensive ways to diagnose AD  Help us enroll patients in clinical trials with confirmed AD  Determine if drug was having impact on disease progression  Fund as a consortium?  Competitive Technology  An AD diagnostic customized for our compound which would allow us to compare how our drug is impacting the patient as compared with similar therapies  Fund on our own 12
  • 13. Productivity Challenge $40 $35 Total R&D Investment ($Billions) $30 $25 $20 $15 $10 $5 $0 2005 2000 1985 1990 1995 1970 1975 1980 13 Source: 2006 PhRMA Annual Survey
  • 14. Total BioPharmaceutical R&D Spending 2005-2006 ($Billions) $55 Total spending increased by $3.4 B Biotech $50 From 2005 to 2006 20% $45 $40 $35 $30 $25 Pharma $20 80% $15 $10 $5 $0 2005 1995 2000 1970 1985 1990 1975 1980 14 Source: 2006 PhRMA Annual Survey
  • 15. Staying Competitive in a Changing Global Environment: Pfizer’s evolving strategy  Technical expertise is available around the globe  India has chemistry innovation  China has chemistry innovation and clinical trial capacity  South Korea has advanced data collection and transmission, patient monitoring and clinical trial capacity and implementation  All of these countries have scientific and technical experts educated in the west and trained at the top 20 pharmaceutical companies in the west 15
  • 16. Opportunities for Growth and Innovation
  • 17. We are one of the leading source of Biotech funding Industry leading investment in R&D $7.7 $7.5 $7.5 $7.1  Total Strategic Alliances Spending: >$1.4B in the last 4 ($Billions) years $5.2 $4.8 $4.4  “Pfizer…the largest source of discovery stage biotech capital” Source: In Vivo, September 2004 $2.3 $2.3 $1.8 $1.6 1996 1998 2000 2002 2004 2006 Source: Pfizer Annual Report 17
  • 18. Extensive External Reach  2006: Over 1800 business transactions/ >800 collaborations  Global organization of 56 people at 6 sites in US/EU/AustralAsia - predominantly scientific expertise with enhancements:  Finance, Business, Law, Medicine, Marketing/Sales, M&A  Global colleague interaction allows synergistic expertise  Strategic Alliances presently covers all areas of Research and Development including deals/technologies that interface with Manufacturing, Veterinary Medicine, PGP, and Consumer Health Care 18
  • 19. Agreement Types  Non-disclosure agreement  Material transfer agreement  License to patent/intellectual property  Research collaboration  Corporate collaboration (major deal)  Consultantship  Fee for service (outsourcing contracts)  Acquisition of new chemical entities 19
  • 20. Alliance Types  Research – Genes, Leads, Targets, Technology (Scripps)  Candidate Producing (Kosan, ICAgen)  In-Licensing – Early & Late Stage (Renovis, TransTech)  Out-licensing – Assets, IP, Patents, Niche products (Darafenicin)  Joint Venture – Marketing for Products (Insulin production)  Co-promotion Deals – Risk & Reward (Rebif)  M&A – Pipeline, Resources, Financial, Strategic (Rinat, Powdermed) 20
  • 21. Pfizer Global Research and Development Major Alliance Partnerships: March 2006 Speeding/Enhancing Altering the R&D Enhancing Development Productivity Paradigm Pipeline Value Candidates Product Gene Function Screen Lead Candidate Development Speed Enhancement Athersys Affymetrix Biotrove Amgen Neurion Amersham U. Michigan Alza Chondrogene Deltagen Evotec Cerep Vicuron (acqu) U. Cambridge ProModel Atrix (QTL) Metabolex InPharmatica Stem Cell Sci Entelos Wake Forest Curagen Genestruct Ventaira Karolinska Xenogen U. Dundee Spotfire Monogram GeneLogic Codexis Bend U. Pittsburgh Lexicon Gen Xenoport Medarex Rigel Lonza Perlegen Nektar Wash. U Chondrogene Lilly Morphosys Nicox Meridica (acq) Lifespan Freie Univ. Cerep ActivX Quorex Angiosyn Kings Pain Ctr Genizon U. Rochester Perlegen/NIH Sangamo Isis Idun (acqu) NIA Oxford Scripps Odyssey Th. TRansTech Coley Virtual Scopics Biosensors Archimex Renovis Yale Noxxon Symyx GeneLogic Boehringer Ingelheim Chromos iCardiac 21
  • 22. How will Pfizer Invest in New Technologies in 2007 and Beyond? Strategic themes for SA investments Productivity  CAN producing alliances  TA Enablers- focused alliances  Emerging science/technologies investments Leveraging Scale  Cross-line technology investments  Technologies enhancing Speed/Efficiency/Process Flexible Budget Emerging Sciences Periodic review of where SPEED/Efficiency/Process TAPT Enablers we are investing CAN-producing alliances 22
  • 23. Investing In The Future  Gene Therapy  Therapeutic Vaccines  Biomarkers, Diagnostics and Personalized Medicine  Data Management  Pfizer’s Incubator 23 NY 7/31/2006