SlideShare a Scribd company logo
1 of 28
Download to read offline
Oncology
Changing Market Dynamics
February, 2010
Oncology – a new market dynamic on the horizon



                                                            Historically, oncology has been an area of significant sales
                                                            growth due to favorable factors, such as a cooperative FDA,
                                                            premium pricing, and prevalent off-label usage


                                                            However, we see signs of change…
                                                                New drugs and indications are crowding the market
                                                                Payors are having a greater impact on drug utilization
                                                                     “Traditional” tools such as tiered co-payments, prior
                                                                        authorization and step-edits are being used more
                                                                        aggressively throughout the industry
                                                                The industry is responding as well with price caps and
                                                                 pay for performance arrangements


                                                            Overall, we believe industry participants need to pay close
                                                            attention to these signals, and position themselves for a new
                                                            market dynamic




February, 2010   |   Copyright © 2010 Grail Research, LLC           2
Table of Contents
                  Historical Market Dynamics
                  Evidence of Changes
                  Case Studies
                  How to Prepare




February, 2010           |   Copyright © 2010 Grail Research, LLC   3
Oncology agents have experienced exceptional market growth

                            Overview                                                              Global Pharmaceutical and Oncology Market Trend,
                                                                                                                   2004–12Ea,b,f,g
          Oncology products have grown at more
             than double the rate of global                                      125                                                                              1,000          2004-08
                                                                                                                                                          921                     CAGR
             pharmaceuticals, with a CAGR of                                                                                                        864
             8.39% during 2004–’08                                                                                                         807                                       8.39%
                                                                                                                        773      750
          Reasons for the robust growth of the                                  100
                                                                                                               715
                                                                                                                                                                  800                18.92%
             oncology market:c,d,e                                                                      648
                                                                                                 605                                                                             2008-12
                 • Increased use of targeted                                         75   560                                                                     600             CAGR




                                                                            USD Bn
                  therapeutics, including more patients                                                                                                    65
                                                                                                                                                     60




                                                                                                                                                                        USD Bn
                  accessing modern targeted                                                                                       52       55                                        4.5%
                  therapies in emerging markets                                                                          48
                                                                                     50                           42                                              400                7.8%
                 • Premium pricing for targeted brands                                                  35
                  as compared to cytotoxic therapies                                             29
                                                                                          24
                  and antihormonal therapies                                         25                                                                           200
                 • Longer treatment duration for
                  patients due to longer survival and
                  adjuvant treatment                                                 0                                                            0
                                                                                     2004       2005   2006    2007    2008 2009E 2010E 2011E 2012E
                 • Earlier detection of disease with the
                  availability of new screening                                                 Global Pharmaceutical Market
                  procedures                                                                    Oncology Market
                                                                                                IMS Projections – Oncology Market
                                                                                                IMS Projections – Global Pharmaceutical Market


 Note: Projections are extrapolated based on IMS prediction of 3-6% of CAGR till 2012; we have assumed a CAGR of 4.5% till 2012
 Source: a”Global Pharmaceutical Sales, 2001 – 2008”, IMS Health, March 2009; b”Top 15 Global Therapeutic Classes”, IMS Health, March 2009; c"IMS Health forecasts double-digit growth of
 cancer drugs", IMS Health Website, May 15, 2008; d’Commercial Insight: Top 20 Therapy Cancer Brands’, Datamonitor, Aug 2008; e“Nuovifarmacie vecchitrend diconsumo:
 unapanoramicaeuropea”, IMS Presentation; f“Booming oncology market redefines relations between manufacturers and healthcare payers, providers”, Pharmaceutical Commerce Magazine,
 August 2008; g“IMS Health Lowers 2009 Global Pharmaceutical Market Forecast to 2.5 – 3.5 Percent Growth”, IMS Press Release, April 22, 2009
February, 2010               |   Copyright © 2010 Grail Research, LLC                              4
Table of Contents
                  Historical Market Dynamics
                  Evidence of Changes
                  Case Studies
                  How to Prepare




February, 2010           |   Copyright © 2010 Grail Research, LLC   5
Recent events raise the possibility that this market
          dynamic is changing
 1                                                                2



         New drugs and new indications are                            Payors are more aggressive in
               crowding the market                                        managing Biologics

 3                                                                4




                 New Pricing Pressures                                Shift to orals enables traditional
                                                                              utilization controls
February, 2010     |   Copyright © 2010 Grail Research, LLC   6
1 The pipeline for new targeted therapies is significant
                                                                                                                                    Vargatef
                                                                                                                                                     Neratinib        Bosutinib        Anyara (Active
                                                                                                                                  (Boehringer
                                                                                                                                                      (Wyeth)          (Wyeth)            biotech)
                                                                                                                                   Ingelheim)
                                                                          Bexxar
                                                                                                                   Torisel
                                                                           (GSK)
                                                                                                                   (Wyeth)      Zalutumumab          Recentin         Rencarex          Enzastaurin
                                                                                                                                  (Genmab)         (Astra-Zeneca)      (J & J)            (Eli Lilly)


                                                                                                                                                     Herceptin-
                                          Campath                                            Nexavar                              Zactima
                                                                                                                                                       DM1
                                                                                                                                                                      Aflibercept        Zybrestat
                                                                          Erbitux                                   Tykerb      (AstraZeneca)                       (Sanofi Aventis)     (OXiGENE)
                                           (Bayer /                                          (Bayer &                                               (ImmunoGen)
                                                                           (BMS)                                     (GSK)
                                          Genzyme)                                            Onyx)
                                                                                                                                                                    Ofatumumab
                                                                                                                                  Galiximab         Lumiliximab      (Genmab &           Zarnestra
                                                                                                                                 (Biogen Idec)      (Biogen Idec)       GSK)               (J & J)

                                                                      Velcade                Revlimid
                  Herceptin                Gleevec                                                                  Tasigna      Pazopanib
                                                                                                                                                                                         Masatinib
                                                                        (J&J /               (Celgene                                               Deforolimus       Omnitarg
                                                                                                                                                                                         Mesylate
                 (Genentech)              (Novartis)                                                               (Novartis)      (GSK)              (Ariad)          (Roche)
                                                                      Mellinium)              Corp.)                                                                                    (AB Science)




      1997 1998 2000 2001 2002 2003 2004 2005 2006 2007
                                                                                                                                                   LATE STAGE PIPELINE



                                                                                                                                                                      Neuradiab
     Rituxan               Mylotarg                     Iressa                    Avastin               Sutent                   Flavopiridol        Zibotentan                         Midostaurin
                                                                                                                                                                       (Bradmer
                                                                                                                                (Sanofi Aventis)    (AstraZeneca)                        (Novartis)
   (Genentech)             (Wyeth)                   (AstraZeneca)              (Genentech)             (Pfizer)                                                        Pharma)

                                                                                                                                                    BIBW-2992         Vadimezan
                                                                                                                                  AVE 8062                                             Farletuzumab
                                                                                                                                                    (Boehringer      (Novartis and
                                                                                                                                (Sanofi Aventis)                                          (Baxter)
                                                                                                                                                     Ingelheim)        Antisoma)
                                                                                     Tarceva
                                                         Zevalin                                        Vectibix
                                                                                      (OSI /
                                                       (Spectrum)                                       (Amgen)                    Telcyta          Lestaurtinib     Alpharadin           Axitinib
                                                                                    Genentech)
                                                                                                                                    (Telik)          (Cephalon)        (Algeta)           (Pfizer)


                                                                                                                                 Genasense         Ramucirumab       Afutuzumab         Motesanib
                                                                                                        Sprycel                    (Genta)           (Eli Lilly)     (Biogen Idec)       (Amgen)
                                                                                                         (BMS)
                                                                                                                                    XL-184                                               Brivanib
                                                                                                                                                   BSI-201 (BiPar   Figitumumab
                                                                                                                                   (BMS and                                              Alaninate
                                                                                                                                                     Sciences)         (Pfizer)
                                                                                                                                   Exelixis)                                               (BMS)
 Note: Late Stage Pipeline includes only those drugs which are either in Phase III or pre-
 registration stage of development
 Source: Grail Research; PharmaProjects database (accessed in August 2009)
February, 2010                 |   Copyright © 2010 Grail Research, LLC                                   7
1 Many compounds focus on the same biology
                 Competitive intensity is increasing as companies target similar mechanisms


                                                                                                                                        Expected                 Expected
                                                                     Current Level of Competition                                       Near Term               Long Term
                                                                                                                                       Competition1            Competition2


         EGFR
       Antagonist                                                                                                                              2                       8
                                     Epidermal growth factor
                                     receptor 2 antagonist




        VEGFR
       Antagonist                                                                                                                              2                      12




  Tyrosine Kinase
     Inhibitors                                                                                                                                9                       9



Note : The dates mentioned in the chart are approval dates and not the launch dates; 1Represents the number of molecules in phase III / Pre-registration / Registration stage of
development for relevant indications; 2Represents the number of molecules in phase I / II of development; Above mentioned data represent the primary pharmacology action
for the marketed and pipeline molecules (a molecule can target more than one receptors; however, we have only considered the primary target in this analysis)
Sources: FDA website, Company website ; PharmaProjects database; Grail Analysis
February, 2010            |   Copyright © 2010 Grail Research, LLC                      8
1 Adding indications to existing drugs increases competition
                                                                                    Expansion of existing agents


           Gleevec                                      5                                                                               13                                                     18

            Avastin                                     5                                                                     10                                                2        17

           Revlimid           1                 2                                                                        13                                                         16

             Erbitux                  2                             3                                                         10                                        15

                 Sutent               2                                         5                                                  8                                    15

             Tykerb           1                         3                                                7                             11

           Tarceva                    2                             3                            4                   9

           Nexavar                    2                     2                        3               7

            Vectibix          1                 2                               3            6

             Torisel          1                         3                   4
                                                                                                                                                          Early Stage Pipeline Indications
         Herceptin            1           1             1       3                                                                                         Late Stage Pipeline Indications
                                                                                                                                                          Approved Indications
            Rituxan           1           1         2

                          0                     2                       4                6                   8                10             12            14                  16             18

 Note: Late Stage pipeline include molecules in registration / pre-registration / phase III of development, Early Stage pipeline include molecules in phase I or II of development
 Source: PharmaProjects; Clinical Trials Website; Company Websites; “Top 20 Cancer Brands”, Datamonitor
February, 2010                    |   Copyright © 2010 Grail Research, LLC                                       9
1 Many indications will soon have multiple targeted therapies
                  1997          1998           2000          2001             2002       2003       2004         2005           2006           2007          2008          2009                LATE STAGE PIPELINE

 Lymphoma

                  Rituxan                                                    Zevalin                Bexxar                      Velcade
                                                                                                                                                                                         Revlimid; Torisel; Campath; Afutuzumab;
                   (CD20                                                      (DNA                  (DNA                      (Proteasom
                 antagonist)                                               antagonist)            antagonist)                  e inhibitor)                                               Galiximab; Ofatumumab; Enzastaurin


 Breast Cancer

                                Herceptin                                                                                                                   Avastin                    Sutent; Ramucirumab; BSI-201; Pazopanib;
                                                                                                                                              Tykerb
                                 (EGFR
                                                                                                                                               (TKI)
                                                                                                                                                             (VRGF                     Herceptin- DM1; Omnitarg; Neratinib; BIBW-
                               Antagonist)                                                                                                                 Antagonist)                                   2992

 Leukemia
                                                             Gleevec
                                                             (Bcr-Abl                                                                                                                    Revlimid; Rituxan; Alvocidib; Midostaurin;
                                              Mylotarg                                                                          Sprycel        Tasigna
                                                            inhibitor);
                                               (DNA
                                                             Campath
                                                                                                                               (Bcr-Abl       (Bcr-Abl                                    Lestaurtinib; Lumiliximab; Genasense;
                                             antagonist)                                                                       inhibitor)     inhibitor)                                   Ofatumumab; Zarnestra; Bosutinib
                                                           (Lymphocyt
                                                            e inhibitor)
 NSCLC

                                                                                                                                                                                           Erbitux; Sutent; Nexavar; Aflibercept;
                                                                                         Iressa    Tarceva                     Avastin
                                                                                                                                                                                       Vadimezan; Telcyta; Figitumumab; Motesanib;
                                                                                                                                (VRGF
                                                                                         (TKI)       (TKI)                    Antagonist)                                                   Pazopanib; Recentin; BIBW-2992;
                                                                                                                                                                                              Enzastaurin; Zactima; Vargatef

 Colorectal Cancer
                                                                                                    Avastin
                                                                                                    (VRGF
                                                                                                  Antagonist);                 Vectibix
                                                                                                                                                                                           Tarceva; Sutent; Aflibercept; Brivanib
                                                                                                    Erbitux                     (EGFR
                                                                                                                              Antagonist)                                                          Alaninate; Recentin
                                                                                                    (EGFR
                                                                                                  Antagonist)
  Kidney Cancer

                                                                                                                 Nexavar                       Torisel
                                                                                                                                Sutent                                    Avastin
                                                                                                                   (B-raf                      (mTOR
                                                                                                                               (VEGFR                                      (VRGF          Axitinib; Pazopanib; Anyara; Rencarex
                                                                                                                  kinase       Inhibitor)       kinase                   Antagonist)
                                                                                                                 inhibitor)                   inhibitor)


 Note: Late Stage Pipeline includes only those drugs which are either in Phase III or pre-registration stage of development
 Source: Grail Research; PharmaProjects database (accessed in August 2009)
February, 2010                     |   Copyright © 2010 Grail Research, LLC                                           10
2 More aggressive use of utilization tools is underway
             Biologics in Breast Cancer – Usage of utilization tools in 2008 and expected increment in 2011a,2

                                             Commercial health                       Medicare              Managed Medicaid
                                                                                                                                             PBMs1
                                                 plans                            advantage plans               plans
                 Management
                                                                    Incremental               Incremental               Incremental               Incremental
                   strategy                   % of plans
                                                                     % of plans
                                                                                  % of plans
                                                                                               % of plans
                                                                                                            % of plans
                                                                                                                         % of plans
                                                                                                                                      % of plans
                                                                                                                                                   % of plans
                                              using the                           using the                 using the                 using the
                                                                     to use the                to use the                to use the                to use the
                                             tool in 2008                        tool in 2008              tool in 2008              tool in 2008
                                                                    tool in 2011              tool in 2011              tool in 2011              tool in 2011


                  Quantity Limits                36.4%                  14.5%      43.5%           17.4%     29.4%        23.5%        36.4%        27.3%

                   Step Therapy                  14.5%                  23.6%      13.0%           30.4%     17.6%        23.5%         0.0%        36.4%

             Prior Authorization
                                                 56.4%                  7.3%       60.9%           13.0%     52.9%        17.6%        36.4%         9.1%
                by Diagnosis

                 Prior authorization
                                                 34.5%                  21.8%      21.7%           30.4%     41.2%        11.8%         0.0%        36.4%
                   by test results

                 Coinsurance cost
                                                 29.1%                  12.7%      56.5%           13.0%       NA           NA         18.2%         0.0%
                      share



Note: 1PBM is Pharmacy benefit management; 2Survey group include Commercial health plans (N=55), Medicare Advantage plans (N=23), Managed Medicaid
plans (N=17), PBMs (N=11)
Source: aBiotechnology Monitor and Survey, Marketplace Policies, Practices and Perspective: 2009
February, 2010               |   Copyright © 2010 Grail Research, LLC                         11
The cost of cancer therapy is increasing as patients shift to
3                            newer, more expensive therapies

                                                                           New drugs cost more and are increasing share

                                                                                                                                       Average Monthly Medicare Price of Drugs at the Time of
                                   Oncology Drugs Market Share by Launch, 1996–2007a
                                                                                                                                                      Approval (1994-2008)b

                            100                                                                                                        8,000
     Percent Market Share




                                             7       12          18                              8   14
                                                                         27                                21    27                                                                   6,465
                                                                                   36                                   31
                                                                                            35                                         6,000
                                                                                                     37




                                                                                                                                 USD
                                                                                                           38
                            50    100                                                                            38     37             4,000                          3,610
                                        93           88          82      73
                                                                                   64       57       49                                2,000          1,450
                                                                                                           41    35     32
                            0%                                                                                                            0
                                  1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007                                                            1994-1998       1999-2003       2004-2008
                                    Drugs Launched in 2003-07                       Drugs Lanched in 1997 or Before                                              Year of Approval
                                    Drugs Launched in 1998-02

                                        Utilization of Newer therapies is increasing                                                                    New Therapies cost more



                                                                                                     The Cost of Treating Cancer is Increasingc

                                                          100
                                                                                                                                                                    75
  Annual Cost of Treating Cancer                                                                                                               62
           (USD Bn)                                        50                                                     43
                                                                                    30

                                                             0
                                                                                  1990                           1995                      2000                    2005



 Source: a”The Oncology Pipeline: Maturing, Competitive, and Growing?’, Oncology Business Review, Sep 2008; b“Limits on Medicare's Ability to Control
 Rising Spending on Cancer Drugs”, NEJM Article, February 5, 2009; cManaged Care Oncology Magazine, Q3 2008 Issue
February, 2010                                   |   Copyright © 2010 Grail Research, LLC                                12
At the same time, drug benefits may seem modest relative
3         to cost

                    Some of the newly-approved brands cost USD 150-500K per life year gained

                                                                                                                             Incremental      Cost / Life
                                                                                      Year of             Incremental          Cost of       Year Gained
           Drug               Company                                Indication
                                                                                     Approval               Benefit            Therapy          (LYG)
                                                                                                                                (USD)          (USD)1

         Avastina                 Roche                             Breast Cancer      2008              4 months survival      50,000         150,000


                                                                                                          0.127 months
         Tykerbb                    GSK                             Breast Cancer      2007                                     21,484         169,165
                                                                                                             survival

                                                                                                           1.96 months
        Ixemprac                    BMS                             Breast Cancer      2007                                     30,900          189,184
                                                                                                             survival

                                                                    Non-small Cell                                                             345,757–
         Avastinb                 Roche                                                2006          2.3 months survival     66,270–80,343
                                                                     Lung Cancer                                                                419,181

                       OSI Pharmaceuticals /                         Pancreatic                                                                364,680–
        Tarcevab                                                                       2005          0.4 months survival     12,156–16,613
                              Roche                                   Cancer                                                                    498,390

                                                                      Colorectal                           1.44 months
         Erbituxb                   BMS                                                2004                                     21,954         182,950
                                                                       Cancer                                survival




 Notes: 1LYG costs have been derived
 Source: aNew York times; bAmerican Society of Clinical Oncology (ASCO); cJournal of Clinical Oncology
February, 2010           |   Copyright © 2010 Grail Research, LLC                       13
This has led to a new and public discussion about the
3         cost/benefit of these new therapies


                                                                                        Commentary in the press

                                                  New York Times, July 2008 - Cost effectiveness of Avastin - “It’s absolutely critical that we start having a public
                                                  discussion,” said Barbara Brenner, executive director of Breast Cancer Action, an advocacy group. “I think of Avastin
                                                  as a model that is showing us where the problem is.”a


                                                  Bloomberg News, June 2009 - “Eli Lilly & Co.’s tumor-fighter Erbitux doesn’t prolong lung cancer patients’ lives
                                                  enough to justify its $80,000 cost, U.S. scientists said in commentary published today. Erbitux added to other cancer
                                                  drugs extends survival about 1.2 months more than chemotherapy alone, making the price too high for a ‘marginal
                                                  benefit,’ commentary in the Journal of the National Cancer Institute said”b


                                                  Medscape, May 2009 - “Ixabepilone (Ixempra) for metastatic breast cancer is an example of a cancer drug that adds
                                                  ‘a small benefit at a high cost,’ says an editorial in the May 1 edition of the Journal of Clinical Oncology. The editorial
                                                  accompanies a new cost-efficacy study in the same issue of the journal that found that the addition of ixabepilone to
                                                  capecitabine (Xeloda) adds about $31,000 to the overall medical costs of metastatic breast cancer while providing
                                                  about 1 more month of ‘quality-adjusted’ survival”c

                                                  The Independent, August 2008 - “The National Institute for Health and Clinical Excellence (NICE) issued draft
                                                  guidance rejecting the drugs Sutent (sunitinib), Avastin (bevacizumab), Nexavar (sorafenib) and Torisel
                                                  (temsirolimus)”
                                                  “The guidance rejects the drugs because they are not cost effective”d

                                                  The Wall Street Journal, March 2009 - “Expert advisers in the U.K. are sticking with their view that
                                                  GlaxoSmithKline’s Tykerb is too costly to justify routine use in women with advanced breast cancer. The British
                                                  government’s National Institute for Health Effectiveness, or NICE, put out a final appraisal that said Tykerb hadn’t
                                                  ‘demonstrated that it was cost effective’ in comparison with other treatments. It put forth a similar view last summer”e

 Sources : a“Costly Cancer Drug Offers Hope, but Also a Dilemma”, The New York Times, July 6, 2008; b “Lilly Erbitux Cancer Drug Not Worth Price, U.S.
 Scientists Say”, Bloomberg News, June 2009; c“Ixabepilone in Metastatic Breast Cancer: Small Benefit at High Cost”, Medscape, May 2009; d“NHS denies
 'effective' cancer drugs due to cost”, The Independent, August 2008; e“U.K. Says Tykerb Isn’t Worth Cost, Even With 12 Free Weeks”, The Wall Street Journal,
 March 2009
February, 2010         |   Copyright © 2010 Grail Research, LLC                           14
3 Companies are reacting with price caps…
                                                                    Examples of price cap initiatives



                                                                                                                                  If patients spend more than 5%
    Genentech capped Avastin at                                                                                                  of their annual gross income on
      USD 55,000/year for patients with                        In Oct. 2006,                            In Sept. 2006,            copayments, then they become
      a household income less than                              Genentech                                   Amgen                eligible for free drugs through an
      $75,000 a yeard                                         announced a                                instituted a                          assistance programb
                                                               price cap on                              price cap on
                                                              Avastin based                               Vectibix at
                                                              on a patient’s                           $4,000 per dose
                                                                 incomea                               (20% lower than
                                                                                                       BMS’s Erbitux)d
                                                                                 Price
                                                                                 Caps
                                                                               Employed
                                                             In May 2006,       as a Tool                   The UK
                                                                  BMS                                     government
                                                             announced a                                  (NICE) uses
   Patients who spend over USD                              price cap on                                 cost/benefit             A threshold of GBP 30,000 per
     10,000/month become eligible                             Erbitux for                                  analysis in                    quality-adjusted life year
     for free or discounted drugs                            patients that                                 evaluating                  (QALY) is used in evaluating
     through a charitable programa                              reach a                                      drugsc                      drugs for reimbursementc
                                                                monthly
                                                               threshold




 Sources : a”Contracting, rebating, risk-sharing – IMS Conference hears about more innovative approaches to pricing”, IMS Global Insights; b“Managed Care
 Best Practices in Oncology Management”, Conference report, November 2006; c“Cost-Effectiveness of Cancer Drugs Is Questioned”, The Wall Street Journal, June 2009 and
 “Time to Consider Cost in Evaluating Cancer Drugs in United States?”, Medscape Today, July 2009 ; d“Top Of The Cancer Market?”, Forbes, October 2006
February, 2010           |   Copyright © 2010 Grail Research, LLC                  15
3 … and pay for performance arrangements
          Drug companies are increasingly offering discounts to insurers based on drug performance
          rather than quantity of drug utilized1

                                                                                                Pay for Performance Examples
                                                                  In 2001 Pfizer convinced the State of Florida to put all its drugs on the state's Medicaid formulary.
                                                                    In return Pfizer agreed to rebate a portion of drug costs if its drugs failed to generate long-term cost
                                                                    savings across the healthcare systema
                                                                        • This model worked for Pfizer, enabling the company to avoid up-front discounts and back-end
                                                                          rebates, while saving the State of Florida USD 41.9MM in other healthcare costsa

                                                                  In 2007, after the NHS in Britain decided not to pay for the cancer drug Velcade, Johnson &
                                                                    Johnson offered a money-back guarantee if Velcade failed to reduce tumors by at least 25%b,c
                                                                        • Through this Pay for Performance strategy, the NHS designated Velcade as cost-effective for
                                                                          up to four cycles of treatmentc

                                                                  In 2007, United Healthcare entered into a risk sharing agreement with Genomic Health. The
                                                                    company sells Oncotype DX®, a USD 3,460 genetic test that determines whether an early-stage
                                                                    breast cancer patient would benefit from chemotherapyc
                                                                        • United Healthcare agreed to pay for the test for 18 months, on grounds that it would seek a
                                                                          price negotiation if the test failed to have the intended medical impactc

                                                                  In 2009, in response to a negative UK NICE appraisal, Merck offered to refund the primary care
                                                                    cost of its drug Erbitux, if a patient did not respond within 6 weeksd

                                                                  In 2009, when Tarceva was declared cost ineffective by NICE, Roche offered a rebate for the cost
                                                                    difference between Tarceva and the incumbent NSCLC treatmentd

Note: 1Pay for Performance is more popular in Europe.US, insurers have less leverage with drug makers because of tough state regulations and marketplace pressures
Source: ; a“Money-Back Guarantee”, Pharmaceutical Executive, April 2008; b“Drug Deals Tie Prices to How Well Patients Do”, New York times, April 2009; c“Pricing Pills by the Results”, New York
times, July 2007;d “More Velcade-Style Risk-Sharing In The UK?”, Europharmatoday.com, January 2009;

February, 2010               |   Copyright © 2010 Grail Research, LLC                              16
Companies are also conducting head-to-head trials in order to
3         demonstrate superiority for their agent over alternatives
          The crowded market is resulting in increased pressure on drug companies to conduct head-
          to-head trials to prove that their product is better than the competitor’s product

                                                                                                                                                            Expected Completion
                                                                    Comparison                 Condition                       Trial Sponsor
                                                                                                                                                                   Date


                                                                                                                                                            Results were expected
                                                                        Zactima vs        Second line NSCL                                                   in September 2009;
                                                                                                                                Astrazeneca
                                                                         Tarcevaa             Cancer                                                             Regulatory
                                                                                                                                                            submissions withdrawn

                                                                        Recentin vs      First line metastatic
                                                                                                                                Astrazeneca                           May 2011
                                                                         Avastina         Colorectal Cancer


                                                                        Sutent vs.       First line metastatic
                                                                                                                                     Pfizer                   Halted in June 2009
                                                                        Avastin1,b          Breast Cancer


                                                                        Sprycel vs                                              Bristol-Myers
                                                                                             First line CML                                                           Complete
                                                                        Gleevec2,c                                                 Squibb


                                                                        Tykerb vs          Adjuvant Breast
                                                                                                                             GlaxoSmithKline                          May 2013
                                                                        Herceptina             Cancer

 Note: 1Trial halted in June 2009 as better survival rates could not be established; 2FDA approved Sprycel for treatment of CML since the study established better survival rates in Gleevec-
 resistant patients. The drug fulfills the need for second line treatment
 Source: aClinicaltrial.gov, b“Pfizer halts Sutent breast-cancer trial”, fiercepharma.com, June 2009; c“FDA Grants Full Approval For SPRYCEL For The Treatment Of Adults With Chronic Myeloid
 Leukemia”, MedicalNewsToday, May 2009
February, 2010               |   Copyright © 2010 Grail Research, LLC                           17
4 Greater use of oral therapeutics is changing oncology
                                                       Unlike the overall industry, orals are gaining share in Oncology

                                            Percentage of Worldwide Rx & OTC Pharmaceutical Sales from                                                        Share of Biologics Within Top
                                                       Biotech vs. Conventional Technologya                                                                           100 Products

                        100          91    91         90        89          88         87     86          84     83     82        81   80   79   78      77
                         80                                                                                                                                   2014             50%
    Technology % of
    Rx & OTC Sales




                         60
                                                                                                                                                              2008       28%
                         40
                                                                                                                        18        19   20   21   22      23
                                                                                              14          16     17
                         20          9     9          10        11          12         13
                                                                                                                                                              2000    11%

                             0
                             2000         2001       2002      2003       2004       2005    2006        2007   2008   2009E 2010E 2011E 2012E 2013E 2014E           0% 10% 20% 30% 40% 50% 60%
                                            Biologics                 Conventional


                                                         Oncology Market for Targeted Therapies: Biologics vs. Conventional Technologyb

                       100
                                 100                                                                74
    % of Total Sales




                        80                                                                                                                        69                                        66
                        60
                                                                                                                                                  31                                        34
                        40                                                                          26
                        20
                                 0
                         0
                         2000                                                                  2006                                              2010E                                     2015E
                                           Conventional                   Biologics


Source: aWorld Preview 2014, May 2009, Evaluate Pharma report; bMonthly oncology report, October 22, 2007, Rodman and Renshaw equity research

February, 2010                                   |    Copyright © 2010 Grail Research, LLC                                   18
4 Oral oncologics are managed using traditional utilization tools…
  Traditional tools such as tier status, prior authorization, quantity limits and co-payments are
                                 being adopted for oral oncologics
                                                                                                                 Formulary Status of Oral Oncology Brandsa,1
                                      2,000
      Number of PDPs covering drugs




                                                            1,645                                 1,648                          1,648                       1,648               1,648                 1,648
                                                                           34                                    34                        34                         34                     34
                                      1,500                                                                                                                                                            204
                                                                417                                417                           417                         417                  417


                                      1,000

                                                                882                                879                           879                         873                  877                  1,444
                                       500

                                                                                        41                                       207                         174                  210
                                                                274                                275
                                                  36                       2                                     2               109       2                 148      2           108        2
                                         0
                                                        Glivec                                   Sutent                         Tarceva                   Thalomid               Tykerb              Tamoxifen

                                                   Tier 6             Tier 5          Tier 4            Tier 3         Tier 2     Tier 1

                                                                        % of Plans with                               Primary Tier                  % of Plans:             % of Plans:           Primary Cost-
                                          Drug
                                                                       Drug on Formulary                               Placement                Prior Authorization        Quantity Limits        Sharing Range
                                        Gleevec                                  100%                                       4                          70%                      29%                26% - 35%

                                         Sutent                                  100%                                       4                          62%                      32%                26% - 35%

                                        Tarceva                                  100%                                       4                          62%                      32%                 26% - 35%

                                        Thalomid                                 100%                                       4                          68%                      25%                26% - 35%

                                         Tykerb                                  100%                                       4                          74%                      42%                26% - 35%

                                       Tamoxifen                                 100%                                       1                          0%                       2%                  $ 0 - $10

Note: 1Selected drugs include Glivec, Sutent, Tarceva, Thalomid, Tykerb and Tamoxifen (Data from November 2008 for Medicare Part D plan)
Source:a“Cost Sharing for Cancer Patients in Medicare, 2009”, Avalere Health and American Cancer Society Cancer Action Network, December 2008

February, 2010                                              |    Copyright © 2010 Grail Research, LLC                                      19
4 … and this trend is increasing over time
                            PDP’s are increasing the use of traditional utilization tools such as prior authorization
                                                               and co-payments
                                                  PDP’s1 Requiring
                                                                                                                                                                               % Coinsurance Amount, 2006-2009a
                                           Prior Authorization, 2006–2009a
                            80                  76                                                                                                                        35             33               33                 33                              33




                                                                                                                                            Enrollment-Weighted Average
                                                                                                                  71    71        72                                                30                                  30             30 30 31




                                                                                                                                              Coinsurance Amount (%)
                                                                          68                  68        67                                                                                              30                                              30
                                                                                                             64                                                           30                       29                                              29
                                           60
                                                                     63                                                      62                                                27 28          27                27 28             28
     PDPs requiring Prior




                            60                            57                             55
      authorization (% )




                                                                53                                                                                                        25
                                      48                                                           46
                                 40                                              41 42                                                                                    20
                            40
                                                                                                                                                                          15

                                                                                                                                                                          10
                            20
                                                                                                                                                                          5

                            0                                                                                                                                             0
                                  Gleevec                    Sutent               Tarceva           Thalomid           Tykerb2                                                  Gleevec        Sutent            Tarceva            Thalomid      Tykerb2

                                  2006                   2007             2008       2009                                                                                         2006        2007             2008          2009


       PDPs are increasing the use of prior authorization to                                                                                PDPs are shifting the cost burden to the patients by
                  control access to branded cancer                                                 drugsa,b                                                      gradually increasing co-insurance amounts for
                        • However, the administrative burden of obtaining                                                                                        brand-name oral anticancer drugsa
                            prior authorization is high, and the process is time-
                            consuming for payers and providersb




 Note: 1PDP’s are Prescription Drug Plans; 22006 data omitted for Tykerb because the Food and Drug Administration (FDA) approved the drug in March 2007
 Source: a“Cost Sharing for Cancer Patients in Medicare, 2009”, Avalere Health and American Cancer Society Cancer Action Network, December, 2008; b“Oncology trends report”, NCCN
February, 2010                                       |   Copyright © 2010 Grail Research, LLC                                          20
Table of Contents
                  Historical Market Dynamics
                  Evidence of Changes
                  Case Studies
                  How to Prepare




February, 2010           |   Copyright © 2010 Grail Research, LLC   21
Case Studies: Close But Not Yet

                                                             We are clearly seeing different dynamics in the
                                                             oncology market than we have historically


                                                             However, we have not yet seen significant
                                                             competition driven solely by pricing. This is a
                                                             scenario which could emerge when there are
                                                             multiple, largely equivalent agents available in
                                                             the marketplace


                                                             To date, potential competitive situations
                                                             (Erbitux vs Vectibix, Nexavar vs Sutent and
                                                             Tykerb vs Herceptin) have resolved quickly
                                                             with clear winners based on clinical data,
                                                             labeling, and physician preference (not payor
                                                             pressure)




February, 2010   |   Copyright © 2010 Grail Research, LLC           22
Case Study 1 – Vectibix position to displace the similar Erbitux
         was thwarted by clinical data

                                                                                           Erbitux vs Vectibix

                                     Scenario at Launch                                                                                                What Happened?
     Erbitux was launched by BMS/Imclone in 2004 for metastatic                                                      In March 2007, Amgen discontinued a trial of Vectibix due to 231
        colorectal cancer patients1                                                                                    cases of death or disease progression. Vectibix sales in the second
     Vectibix was launched in September 2006 by Amgen for metastatic                                                  quarter of 2007 fell from USD 51MM to USD 46MMe,f
        colorectal cancer patients2                                                                                   Erbitux maintained steady growth even after the launch of Vectibix
          • Analysts expected that Vectibix would replace Erbitux as a                                                   • The total number of patients treated with Erbitux increased in
         treatment for colon cancera,b                                                                                       October 2007, and market share rose to 14.8% in that month g
     Both Vectibix and Erbitux are antibody-based therapies that are                                                    • Vectibix did not show any month-to-month market share
      administered intravenously; however Vectibix had a few potential                                                       increase (in October 2007) and was underperforming according
      advantages                                                                                                             to analystsg
          • More convenient (every other week) administration and lower                                               In 2009, label changes for both Erbitux and Vectibix were
              cost (20% discount) compared to Erbituxb                                                                 implemented; these are expected to narrow the eligible pool of
          • Lower frequency of infusion reactions (1% compared to 3% for                                               patients for both the drugs by up to 40%h
              Erbitux) i,j
     Sales of Vectibix in 2006 (Oct-Dec) were USD 39MM and the
        company was upbeat about the futurec
     Analysts at Merrill Lynch predicted that Vectibix would eventually
        take 60% of Erbitux's market. They also lowered their projected
        sales figures for Erbitux for 2008-2010d


Note: 1Approved as a single agent for EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens or in patients who are intolerant to irinotecan-based regimens OR used in
combination with irinotecan, EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy; 2Approved as a single agent for the treatment of metastatic colorectal carcinoma with
disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens
Source: aPress release, September 27, 2006, Amgem company website; b“Vectibix Will be EGFR Antibody of Choice for Colon Cancer Therapy”, October 6, 2006, GLG group website; cAnalyst conference summary of Amgen
quarter results, January 27, 2007, Openicon website; d”Amgen wins approval for colorectal cancer drug”, September 28, 2006, Marketwatch website; e”Amgen Discontinues Vectibix(TM) Treatment in PACCE Trial Evaluating
Vectibix(TM) as Part of Triple Combination Regimen”, March 23, 2007, Biotechnoloogy-europe website; fPress Release, July 26, 2007, Pfizer company website; g“Monthly oncology regimen report through September 2007”,
Rodman & Renshaw, Inc.,October 22, 2007; h“New US labelling for Erbitux and Vectibix recommends against their use for large subset of colorectal cancer patients”, July 20, 2009, Scripnews website; i"Vectibix(R) Now Available
For The Treatment Of Advanced Colorectal Cancer In Belgium, October 03, 2008, Medicalnewstoday website; jErbitux website
"
February, 2010                     | Copyright © 2010 Grail Research, LLC                                       23
Case Study 2 – In another potential head-to-head battle,
          physicians chose Sutent over Nexavar

                                                                                   Nexavar vs Sutent

                                  Scenario at Launch                                                                                                What Happened?

      Nexavar was launched by Bayer/Onyx in December 2005 for                                             Sutent rapidly captured over 50% market share in renal cell
          advanced renal cell            carcinomaa,2                                                         carcinoma for all lines of therapy (July 2006)d
      Sutent was launched by Pfizer in 2006 for the same                                                                       • Sutent became the standard therapy for first-line
          indication1                                                                                                               treatment of mRCC after launche;
      Direct competition was expected:                                                                                         • Nexavar competed more successfully in second line
                 • Datamonitor forecasted Nexavar revenues would                                                                    therapy with 35.1% patients receiving Sutent and
                   reach USD 122MM and Sutent would reach USD                                                                       32.4% receiving Nexavar (October 2007)d
                   179MM by 2010b
                 • Although Nexavar had a first-to-market advantage,                                                                  Renal Cell Carcinoma Market share
                   Sutent was expected to have superior efficacye
                                                                                                                              100           (All stages/ All lines)d                              Nexavar

                                                                                                                              80                                                                  Sutent
                 • Nexavar on the other hand, was expected to have
                   better tolerability – side-effects were limited mainly to                                                              54   53                        53   53   55   55   56

                                                                                                             Market Share %
                                                                                                                              60     52              51   51   51   51
                   blistering and rashesc
                                                                                                                                     34   32   32    34   34   32   33   33   34   33   33   33
                                                                                                                              40
     • Cost of treatment was similar for both Sutent and Nexavar at
          USD 4,600 per treatment/monthd                                                                                      20

                                                                                                                               0
                                                                                                                               06/2006 08/2006 10/2006 12/2006 02/2007 04/2007 06/2007
Note: 1Sutent is a kinase inhibitor indicated for the treatment of: (i)Gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate (ii) Advanced renal cell carcinoma;
2Nexavar is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma

Source: aPress Release, December 20, 2005, Company website; b”Stakeholder Opinions: Renal Cell Carcinoma - Novel Targeted Treatments to Fill the Void”, December 2005,
Researchandmarkets report; c”FDA approves Bayer's kidney cancer drug”, December 22, 2005, Pharmafocus Website; d”Torisel: The New Kid on the Block for Advanced Renal Cell Carcinoma”,
September 2007, Oncbiz website; e”Nexavar and Sutent, Both Indicated for Metastatic RCC, Look Set to Compete Well to the End of the Decade - Nexavar's 2010 Revenues Are Forecast to
Reach $122 Million and Sutent's $179 Million”, February 13, 2006, Business Wire
February, 2010                |   Copyright © 2010 Grail Research, LLC                               24
Case Study 3 – Tykerb could not displace Herceptin without
          more data and a better label

                                                                                  Tykerb vs Herceptin

                                   Scenario at Launch                                                                                     What Happened?
     Herceptin was the first targeted therapy to be launched for the treatment of  Tykerb reported modest global sales of USD 145.3MM in 2008d
      breast cancer in 1998                                                           • Sales were far behind Herceptin’s, which recorded global sales of USD
     Tykerb (oral therapy) was launched in 2007 as combination therapy with            1.82 billion in 2008h
      capecitabine (Xeloda), for the treatment of patients with advanced or         Factors contributing to Tykerb’s limited revenues were:
      metastatic breast cancer (mBC) with HER2 over-expression and who
                                                                                      • In August 2007, a study conducted by Decision Resources suggested
        progressed on prior therapy including an anthracycline, a taxane, and
                                                                                                               that oncologists did not prefer Tykerb as a replacement for Herceptin.
        Herceptine
                                                                                                               Instead they were only using it as an alternative for Herceptin-refractory
         • Tykerb was approved in a second or third line settingk                                              patients in the treatment of advanced breast cancerk
         • At the time of launch, GSK marketed Tykerb as a more convenient and                               • 58% of oncologists opined that they would favor IV Herceptin over
             user-friendly oral therapyg                                                                       Tykerb because the administration of IV drugs remains an important
     Expectations for Tykerb were mixed at the time of launch:                                                source of income for their practicec
       • Some analysts expected the drug to achieve blockbuster status by                                   To boost revenues from Tykerb in breast cancer, the company decided to
             2010a. Analysts assumed that drug would be effective in difficult to treat                     expand use of Tykerb in an adjuvant setting:
             patients and patients with brain metastases, Tykerb was expected to                             • As of April 2007, GSK was studying Tykerb for its application in adjuvant
             gain share in first line and adjuvant settings.                                                   breast cancer : "We are dedicated to the further study and development
         • Others predicted Tykerb’s use would be limited until it demonstrated                                of Tykerb in a variety of settings, including adjuvant breast cancer as
             significant benefits when added to Herceptin.                                                     well as in other solid tumor types“j
         • Analysts forecasted Tykerb sales to reach USD 104 MM1 in 2008b                                        -Paolo Paoletti, MD, Oncology Medicine Development Center,GSK
     At the time of launch, analyst expected the biggest sales opportunity for                              • GSK launched a head-to-head trial of Tykerb versus Herceptin in
        Tykerb to be in the adjuvant setting in the breast cancer marketb                                      adjuvant breast cancer in 2008. Results for this trial are expected by May
                                                                                                               2013f
                                                                                                             • In April 2009, GSK submitted an application to expand Tykerb use for
                                                                                                               first-line treatment of metastatic breast canceri

Note: 1Reported as £ 62 million, conversion factor used as on November 16, 2009
Source: a“Analysts raise NPVs of Promacta and Rezonic; Tykerb still star of GSK oncology pipeline”, Goliath Business News, July 2007 ; bBear Stearns report September 21, 2007; cPR News wire August 14,
2007; dGSK Annual Report, 2008; Grail analysis; eDrugs @ FDA; fClinicaltrial.gov; gkomenozark.org; hGenentech Website; iGSK press release; j“Tykerb Approved for Metastatic HER2+ Breast Cancer “,
cancernetwork.com, April 2007; k“Glaxo's Tykerb still has some convincing to do”, Evaluate Pharma, March 2008

February, 2010                 |   Copyright © 2010 Grail Research, LLC                               25
Table of Contents
                  Historical Market Dynamics
                  Evidence of Changes
                  Case Studies
                  How to Prepare




February, 2010           |   Copyright © 2010 Grail Research, LLC   26
Preparing for a New Dynamic

                                                             While direct, payor-driven competition among
                                                             oncology agents has not yet arrived,
                                                             manufacturers need to be prepared for
                                                             changes in the oncology market


                                                             Manufacturers may want to conduct head-to-
                                                             head trials, or define market subsets where
                                                             they can demonstrate superiority to potential
                                                             alternative agents


                                                             Manufacturers may also want to consider
                                                             scenarios where there are multiple agents with
                                                             similar therapeutic profiles available for a
                                                             given indication




February, 2010   |   Copyright © 2010 Grail Research, LLC           27
For More Information Contact:

                   Grail Research
                     (info@grailresearch.com)




                                                                        Copyright © 2010 by Grail Research, LLC
                                                                        No part of this publication may be reproduced, stored in a retrieval
                                                                        system, or transmitted in any form or by any means —
                                                                        electronic, mechanical, photocopying, recording, or otherwise — without
                                                                        the permission of Grail Research, LLC




February, 2010          |   Copyright © 2010 Grail Research, LLC   28

More Related Content

What's hot

johnson & johnson Q4 2008 Investor Relations Business Overview
johnson & johnson Q4 2008 Investor Relations Business Overview johnson & johnson Q4 2008 Investor Relations Business Overview
johnson & johnson Q4 2008 Investor Relations Business Overview finance4
 
Amg investor presentation july 2012
Amg   investor presentation july 2012Amg   investor presentation july 2012
Amg investor presentation july 2012jdiluzio
 
Amg investor presentation nov 2012 v-f
Amg   investor presentation nov 2012 v-fAmg   investor presentation nov 2012 v-f
Amg investor presentation nov 2012 v-fjdiluzio
 
Metabolic Disorders White Paper
Metabolic   Disorders White PaperMetabolic   Disorders White Paper
Metabolic Disorders White Paperybarshay
 
Bank of America 38th Annual Investment Conference
Bank of America 38th Annual Investment ConferenceBank of America 38th Annual Investment Conference
Bank of America 38th Annual Investment Conferencefinance5
 
Pfizer to Acquire Wyeth
Pfizer to Acquire WyethPfizer to Acquire Wyeth
Pfizer to Acquire Wyethfinance5
 

What's hot (7)

johnson & johnson Q4 2008 Investor Relations Business Overview
johnson & johnson Q4 2008 Investor Relations Business Overview johnson & johnson Q4 2008 Investor Relations Business Overview
johnson & johnson Q4 2008 Investor Relations Business Overview
 
Amg investor presentation july 2012
Amg   investor presentation july 2012Amg   investor presentation july 2012
Amg investor presentation july 2012
 
Amg investor presentation nov 2012 v-f
Amg   investor presentation nov 2012 v-fAmg   investor presentation nov 2012 v-f
Amg investor presentation nov 2012 v-f
 
Metabolic Disorders White Paper
Metabolic   Disorders White PaperMetabolic   Disorders White Paper
Metabolic Disorders White Paper
 
Bank of America 38th Annual Investment Conference
Bank of America 38th Annual Investment ConferenceBank of America 38th Annual Investment Conference
Bank of America 38th Annual Investment Conference
 
1Q06 Results
1Q06 Results1Q06 Results
1Q06 Results
 
Pfizer to Acquire Wyeth
Pfizer to Acquire WyethPfizer to Acquire Wyeth
Pfizer to Acquire Wyeth
 

Similar to Oncology changing-market-dynamics

Diagnostics Industry Outlook Asia 2009.
Diagnostics Industry Outlook Asia 2009.Diagnostics Industry Outlook Asia 2009.
Diagnostics Industry Outlook Asia 2009.Jasminder_Kaur
 
Membrane Bioreactor Market PPT(2021- 2026) : Global Trends, Scope, Demand, O...
Membrane Bioreactor  Market PPT(2021- 2026) : Global Trends, Scope, Demand, O...Membrane Bioreactor  Market PPT(2021- 2026) : Global Trends, Scope, Demand, O...
Membrane Bioreactor Market PPT(2021- 2026) : Global Trends, Scope, Demand, O...IMARC Group
 
Global Pharmaceuticals & Biotechnology Industry
Global Pharmaceuticals & Biotechnology IndustryGlobal Pharmaceuticals & Biotechnology Industry
Global Pharmaceuticals & Biotechnology IndustryGavin Pathross
 
Catalent (CTLT) Equity Report
Catalent (CTLT) Equity ReportCatalent (CTLT) Equity Report
Catalent (CTLT) Equity ReportLeon Stempert
 
ameren AGA_043007
ameren AGA_043007ameren AGA_043007
ameren AGA_043007finance30
 
Adhesion Barriers Market by Product Type, Distribution Channel, End User 2024...
Adhesion Barriers Market by Product Type, Distribution Channel, End User 2024...Adhesion Barriers Market by Product Type, Distribution Channel, End User 2024...
Adhesion Barriers Market by Product Type, Distribution Channel, End User 2024...IMARC Group
 
Bloomberg New Energy Finance Company Overview 2010
Bloomberg New Energy Finance Company Overview 2010Bloomberg New Energy Finance Company Overview 2010
Bloomberg New Energy Finance Company Overview 2010New Energy Finance
 
Walgreen Co. First Quarter 2009 Earnings Conference
Walgreen Co. First Quarter 2009 Earnings Conference Walgreen Co. First Quarter 2009 Earnings Conference
Walgreen Co. First Quarter 2009 Earnings Conference finance4
 
New Drug Opportunity Assessments Strat Planning For Future Success
New Drug Opportunity Assessments  Strat Planning For Future SuccessNew Drug Opportunity Assessments  Strat Planning For Future Success
New Drug Opportunity Assessments Strat Planning For Future SuccessPharmacision LLC
 
Shunt Reactor Market Report in PPT: Top Companies, Trends and Future Details ...
Shunt Reactor Market Report in PPT: Top Companies, Trends and Future Details ...Shunt Reactor Market Report in PPT: Top Companies, Trends and Future Details ...
Shunt Reactor Market Report in PPT: Top Companies, Trends and Future Details ...IMARC Group
 
ameren MidwestUtilities_041007
ameren MidwestUtilities_041007ameren MidwestUtilities_041007
ameren MidwestUtilities_041007finance30
 
metlife Investor Day 2008 International
metlife Investor Day 2008 Internationalmetlife Investor Day 2008 International
metlife Investor Day 2008 Internationalfinance5
 
Polyvinyl Alcohol Market PPT 2021-26 | Enhancing Huge Growth and Latest Tren...
Polyvinyl Alcohol  Market PPT 2021-26 | Enhancing Huge Growth and Latest Tren...Polyvinyl Alcohol  Market PPT 2021-26 | Enhancing Huge Growth and Latest Tren...
Polyvinyl Alcohol Market PPT 2021-26 | Enhancing Huge Growth and Latest Tren...IMARC Group
 
bristol myerd squibb bristol myerd squibb
bristol myerd squibb bristol myerd squibb bristol myerd squibb bristol myerd squibb
bristol myerd squibb bristol myerd squibb finance13
 
bristol myerd squibb Bristol-Myers Squibb at the J.P. Morgan 27th Annual ...
bristol myerd squibb  	  Bristol-Myers Squibb at the J.P. Morgan 27th Annual ...bristol myerd squibb  	  Bristol-Myers Squibb at the J.P. Morgan 27th Annual ...
bristol myerd squibb Bristol-Myers Squibb at the J.P. Morgan 27th Annual ...finance13
 
Cpfl energia institucional jun11_eng_final
Cpfl energia institucional jun11_eng_finalCpfl energia institucional jun11_eng_final
Cpfl energia institucional jun11_eng_finalCPFL RI
 
Cpfl energia institucional mai11_eng_final
Cpfl energia institucional mai11_eng_finalCpfl energia institucional mai11_eng_final
Cpfl energia institucional mai11_eng_finalCPFL RI
 

Similar to Oncology changing-market-dynamics (20)

Diagnostics Industry Outlook Asia 2009.
Diagnostics Industry Outlook Asia 2009.Diagnostics Industry Outlook Asia 2009.
Diagnostics Industry Outlook Asia 2009.
 
IHPMMA
IHPMMAIHPMMA
IHPMMA
 
EDP Energias do Brasil Presentation
EDP Energias do Brasil PresentationEDP Energias do Brasil Presentation
EDP Energias do Brasil Presentation
 
Membrane Bioreactor Market PPT(2021- 2026) : Global Trends, Scope, Demand, O...
Membrane Bioreactor  Market PPT(2021- 2026) : Global Trends, Scope, Demand, O...Membrane Bioreactor  Market PPT(2021- 2026) : Global Trends, Scope, Demand, O...
Membrane Bioreactor Market PPT(2021- 2026) : Global Trends, Scope, Demand, O...
 
Global Pharmaceuticals & Biotechnology Industry
Global Pharmaceuticals & Biotechnology IndustryGlobal Pharmaceuticals & Biotechnology Industry
Global Pharmaceuticals & Biotechnology Industry
 
Catalent (CTLT) Equity Report
Catalent (CTLT) Equity ReportCatalent (CTLT) Equity Report
Catalent (CTLT) Equity Report
 
ameren AGA_043007
ameren AGA_043007ameren AGA_043007
ameren AGA_043007
 
Adhesion Barriers Market by Product Type, Distribution Channel, End User 2024...
Adhesion Barriers Market by Product Type, Distribution Channel, End User 2024...Adhesion Barriers Market by Product Type, Distribution Channel, End User 2024...
Adhesion Barriers Market by Product Type, Distribution Channel, End User 2024...
 
Bloomberg New Energy Finance Company Overview 2010
Bloomberg New Energy Finance Company Overview 2010Bloomberg New Energy Finance Company Overview 2010
Bloomberg New Energy Finance Company Overview 2010
 
Walgreen Co. First Quarter 2009 Earnings Conference
Walgreen Co. First Quarter 2009 Earnings Conference Walgreen Co. First Quarter 2009 Earnings Conference
Walgreen Co. First Quarter 2009 Earnings Conference
 
Outsourcing
OutsourcingOutsourcing
Outsourcing
 
New Drug Opportunity Assessments Strat Planning For Future Success
New Drug Opportunity Assessments  Strat Planning For Future SuccessNew Drug Opportunity Assessments  Strat Planning For Future Success
New Drug Opportunity Assessments Strat Planning For Future Success
 
Shunt Reactor Market Report in PPT: Top Companies, Trends and Future Details ...
Shunt Reactor Market Report in PPT: Top Companies, Trends and Future Details ...Shunt Reactor Market Report in PPT: Top Companies, Trends and Future Details ...
Shunt Reactor Market Report in PPT: Top Companies, Trends and Future Details ...
 
ameren MidwestUtilities_041007
ameren MidwestUtilities_041007ameren MidwestUtilities_041007
ameren MidwestUtilities_041007
 
metlife Investor Day 2008 International
metlife Investor Day 2008 Internationalmetlife Investor Day 2008 International
metlife Investor Day 2008 International
 
Polyvinyl Alcohol Market PPT 2021-26 | Enhancing Huge Growth and Latest Tren...
Polyvinyl Alcohol  Market PPT 2021-26 | Enhancing Huge Growth and Latest Tren...Polyvinyl Alcohol  Market PPT 2021-26 | Enhancing Huge Growth and Latest Tren...
Polyvinyl Alcohol Market PPT 2021-26 | Enhancing Huge Growth and Latest Tren...
 
bristol myerd squibb bristol myerd squibb
bristol myerd squibb bristol myerd squibb bristol myerd squibb bristol myerd squibb
bristol myerd squibb bristol myerd squibb
 
bristol myerd squibb Bristol-Myers Squibb at the J.P. Morgan 27th Annual ...
bristol myerd squibb  	  Bristol-Myers Squibb at the J.P. Morgan 27th Annual ...bristol myerd squibb  	  Bristol-Myers Squibb at the J.P. Morgan 27th Annual ...
bristol myerd squibb Bristol-Myers Squibb at the J.P. Morgan 27th Annual ...
 
Cpfl energia institucional jun11_eng_final
Cpfl energia institucional jun11_eng_finalCpfl energia institucional jun11_eng_final
Cpfl energia institucional jun11_eng_final
 
Cpfl energia institucional mai11_eng_final
Cpfl energia institucional mai11_eng_finalCpfl energia institucional mai11_eng_final
Cpfl energia institucional mai11_eng_final
 

Recently uploaded

Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024EwoutSteyerberg1
 
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaMale Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaSujoy Dasgupta
 
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfCONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfDolisha Warbi
 
Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Peter Embi
 
historyofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusanguhistoryofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusangu Medical University
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE Mamatha Lakka
 
blood bank management system project report
blood bank management system project reportblood bank management system project report
blood bank management system project reportNARMADAPETROLEUMGAS
 
How to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturallyHow to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturallyZurück zum Ursprung
 
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.pptRamDBawankar1
 
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.aarjukhadka22
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyMedicoseAcademics
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdfHongBiThi1
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisSujoy Dasgupta
 
Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Vaikunthan Rajaratnam
 
"Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio..."Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio...Sujoy Dasgupta
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfMedicoseAcademics
 
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfPAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfDolisha Warbi
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionkrishnareddy157915
 

Recently uploaded (20)

Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024Trustworthiness of AI based predictions Aachen 2024
Trustworthiness of AI based predictions Aachen 2024
 
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy DasguptaMale Infertility Panel Discussion by Dr Sujoy Dasgupta
Male Infertility Panel Discussion by Dr Sujoy Dasgupta
 
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdfCONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
CONNECTIVE TISSUE (ANATOMY AND PHYSIOLOGY).pdf
 
Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024Clinical Research Informatics Year-in-Review 2024
Clinical Research Informatics Year-in-Review 2024
 
historyofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusanguhistoryofpsychiatryinindia. Senthil Thirusangu
historyofpsychiatryinindia. Senthil Thirusangu
 
BENIGN BREAST DISEASE
BENIGN BREAST DISEASE BENIGN BREAST DISEASE
BENIGN BREAST DISEASE
 
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
Immune labs basics part 1 acute phase reactants ESR, CRP Ahmed Yehia Ismaeel,...
 
blood bank management system project report
blood bank management system project reportblood bank management system project report
blood bank management system project report
 
How to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturallyHow to cure cirrhosis and chronic hepatitis naturally
How to cure cirrhosis and chronic hepatitis naturally
 
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D.  Bawankar.pptPharmacokinetic Models by Dr. Ram D.  Bawankar.ppt
Pharmacokinetic Models by Dr. Ram D. Bawankar.ppt
 
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
Bulimia nervosa ( Eating Disorders) Mental Health Nursing.
 
Female Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before PregnancyFemale Reproductive Physiology Before Pregnancy
Female Reproductive Physiology Before Pregnancy
 
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdfSGK ĐIỆN GIẬT ĐHYHN        RẤT LÀ HAY TUYỆT VỜI.pdf
SGK ĐIỆN GIẬT ĐHYHN RẤT LÀ HAY TUYỆT VỜI.pdf
 
Adenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosisAdenomyosis or Fibroid- making right diagnosis
Adenomyosis or Fibroid- making right diagnosis
 
Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.Generative AI in Health Care a scoping review and a persoanl experience.
Generative AI in Health Care a scoping review and a persoanl experience.
 
"Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio..."Radical excision of DIE in subferile women with deep infiltrating endometrio...
"Radical excision of DIE in subferile women with deep infiltrating endometrio...
 
Red Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdfRed Blood Cells_anemia & polycythemia.pdf
Red Blood Cells_anemia & polycythemia.pdf
 
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdfPAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
PAIN/CLASSIFICATION AND MANAGEMENT OF PAIN.pdf
 
EXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung functionEXERCISE PERFORMANCE.pptx, Lung function
EXERCISE PERFORMANCE.pptx, Lung function
 
GOUT UPDATE AHMED YEHIA 2024, case based approach with application of the lat...
GOUT UPDATE AHMED YEHIA 2024, case based approach with application of the lat...GOUT UPDATE AHMED YEHIA 2024, case based approach with application of the lat...
GOUT UPDATE AHMED YEHIA 2024, case based approach with application of the lat...
 

Oncology changing-market-dynamics

  • 2. Oncology – a new market dynamic on the horizon Historically, oncology has been an area of significant sales growth due to favorable factors, such as a cooperative FDA, premium pricing, and prevalent off-label usage However, we see signs of change…  New drugs and indications are crowding the market  Payors are having a greater impact on drug utilization  “Traditional” tools such as tiered co-payments, prior authorization and step-edits are being used more aggressively throughout the industry  The industry is responding as well with price caps and pay for performance arrangements Overall, we believe industry participants need to pay close attention to these signals, and position themselves for a new market dynamic February, 2010 | Copyright © 2010 Grail Research, LLC 2
  • 3. Table of Contents  Historical Market Dynamics  Evidence of Changes  Case Studies  How to Prepare February, 2010 | Copyright © 2010 Grail Research, LLC 3
  • 4. Oncology agents have experienced exceptional market growth Overview Global Pharmaceutical and Oncology Market Trend, 2004–12Ea,b,f,g  Oncology products have grown at more than double the rate of global 125 1,000 2004-08 921 CAGR pharmaceuticals, with a CAGR of 864 8.39% during 2004–’08 807 8.39% 773 750  Reasons for the robust growth of the 100 715 800 18.92% oncology market:c,d,e 648 605 2008-12 • Increased use of targeted 75 560 600 CAGR USD Bn therapeutics, including more patients 65 60 USD Bn accessing modern targeted 52 55 4.5% therapies in emerging markets 48 50 42 400 7.8% • Premium pricing for targeted brands 35 as compared to cytotoxic therapies 29 24 and antihormonal therapies 25 200 • Longer treatment duration for patients due to longer survival and adjuvant treatment 0 0 2004 2005 2006 2007 2008 2009E 2010E 2011E 2012E • Earlier detection of disease with the availability of new screening Global Pharmaceutical Market procedures Oncology Market IMS Projections – Oncology Market IMS Projections – Global Pharmaceutical Market Note: Projections are extrapolated based on IMS prediction of 3-6% of CAGR till 2012; we have assumed a CAGR of 4.5% till 2012 Source: a”Global Pharmaceutical Sales, 2001 – 2008”, IMS Health, March 2009; b”Top 15 Global Therapeutic Classes”, IMS Health, March 2009; c"IMS Health forecasts double-digit growth of cancer drugs", IMS Health Website, May 15, 2008; d’Commercial Insight: Top 20 Therapy Cancer Brands’, Datamonitor, Aug 2008; e“Nuovifarmacie vecchitrend diconsumo: unapanoramicaeuropea”, IMS Presentation; f“Booming oncology market redefines relations between manufacturers and healthcare payers, providers”, Pharmaceutical Commerce Magazine, August 2008; g“IMS Health Lowers 2009 Global Pharmaceutical Market Forecast to 2.5 – 3.5 Percent Growth”, IMS Press Release, April 22, 2009 February, 2010 | Copyright © 2010 Grail Research, LLC 4
  • 5. Table of Contents  Historical Market Dynamics  Evidence of Changes  Case Studies  How to Prepare February, 2010 | Copyright © 2010 Grail Research, LLC 5
  • 6. Recent events raise the possibility that this market dynamic is changing 1 2 New drugs and new indications are Payors are more aggressive in crowding the market managing Biologics 3 4 New Pricing Pressures Shift to orals enables traditional utilization controls February, 2010 | Copyright © 2010 Grail Research, LLC 6
  • 7. 1 The pipeline for new targeted therapies is significant Vargatef Neratinib Bosutinib Anyara (Active (Boehringer (Wyeth) (Wyeth) biotech) Ingelheim) Bexxar Torisel (GSK) (Wyeth) Zalutumumab Recentin Rencarex Enzastaurin (Genmab) (Astra-Zeneca) (J & J) (Eli Lilly) Herceptin- Campath Nexavar Zactima DM1 Aflibercept Zybrestat Erbitux Tykerb (AstraZeneca) (Sanofi Aventis) (OXiGENE) (Bayer / (Bayer & (ImmunoGen) (BMS) (GSK) Genzyme) Onyx) Ofatumumab Galiximab Lumiliximab (Genmab & Zarnestra (Biogen Idec) (Biogen Idec) GSK) (J & J) Velcade Revlimid Herceptin Gleevec Tasigna Pazopanib Masatinib (J&J / (Celgene Deforolimus Omnitarg Mesylate (Genentech) (Novartis) (Novartis) (GSK) (Ariad) (Roche) Mellinium) Corp.) (AB Science) 1997 1998 2000 2001 2002 2003 2004 2005 2006 2007 LATE STAGE PIPELINE Neuradiab Rituxan Mylotarg Iressa Avastin Sutent Flavopiridol Zibotentan Midostaurin (Bradmer (Sanofi Aventis) (AstraZeneca) (Novartis) (Genentech) (Wyeth) (AstraZeneca) (Genentech) (Pfizer) Pharma) BIBW-2992 Vadimezan AVE 8062 Farletuzumab (Boehringer (Novartis and (Sanofi Aventis) (Baxter) Ingelheim) Antisoma) Tarceva Zevalin Vectibix (OSI / (Spectrum) (Amgen) Telcyta Lestaurtinib Alpharadin Axitinib Genentech) (Telik) (Cephalon) (Algeta) (Pfizer) Genasense Ramucirumab Afutuzumab Motesanib Sprycel (Genta) (Eli Lilly) (Biogen Idec) (Amgen) (BMS) XL-184 Brivanib BSI-201 (BiPar Figitumumab (BMS and Alaninate Sciences) (Pfizer) Exelixis) (BMS) Note: Late Stage Pipeline includes only those drugs which are either in Phase III or pre- registration stage of development Source: Grail Research; PharmaProjects database (accessed in August 2009) February, 2010 | Copyright © 2010 Grail Research, LLC 7
  • 8. 1 Many compounds focus on the same biology Competitive intensity is increasing as companies target similar mechanisms Expected Expected Current Level of Competition Near Term Long Term Competition1 Competition2 EGFR Antagonist 2 8 Epidermal growth factor receptor 2 antagonist VEGFR Antagonist 2 12 Tyrosine Kinase Inhibitors 9 9 Note : The dates mentioned in the chart are approval dates and not the launch dates; 1Represents the number of molecules in phase III / Pre-registration / Registration stage of development for relevant indications; 2Represents the number of molecules in phase I / II of development; Above mentioned data represent the primary pharmacology action for the marketed and pipeline molecules (a molecule can target more than one receptors; however, we have only considered the primary target in this analysis) Sources: FDA website, Company website ; PharmaProjects database; Grail Analysis February, 2010 | Copyright © 2010 Grail Research, LLC 8
  • 9. 1 Adding indications to existing drugs increases competition Expansion of existing agents Gleevec 5 13 18 Avastin 5 10 2 17 Revlimid 1 2 13 16 Erbitux 2 3 10 15 Sutent 2 5 8 15 Tykerb 1 3 7 11 Tarceva 2 3 4 9 Nexavar 2 2 3 7 Vectibix 1 2 3 6 Torisel 1 3 4 Early Stage Pipeline Indications Herceptin 1 1 1 3 Late Stage Pipeline Indications Approved Indications Rituxan 1 1 2 0 2 4 6 8 10 12 14 16 18 Note: Late Stage pipeline include molecules in registration / pre-registration / phase III of development, Early Stage pipeline include molecules in phase I or II of development Source: PharmaProjects; Clinical Trials Website; Company Websites; “Top 20 Cancer Brands”, Datamonitor February, 2010 | Copyright © 2010 Grail Research, LLC 9
  • 10. 1 Many indications will soon have multiple targeted therapies 1997 1998 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 LATE STAGE PIPELINE Lymphoma Rituxan Zevalin Bexxar Velcade Revlimid; Torisel; Campath; Afutuzumab; (CD20 (DNA (DNA (Proteasom antagonist) antagonist) antagonist) e inhibitor) Galiximab; Ofatumumab; Enzastaurin Breast Cancer Herceptin Avastin Sutent; Ramucirumab; BSI-201; Pazopanib; Tykerb (EGFR (TKI) (VRGF Herceptin- DM1; Omnitarg; Neratinib; BIBW- Antagonist) Antagonist) 2992 Leukemia Gleevec (Bcr-Abl Revlimid; Rituxan; Alvocidib; Midostaurin; Mylotarg Sprycel Tasigna inhibitor); (DNA Campath (Bcr-Abl (Bcr-Abl Lestaurtinib; Lumiliximab; Genasense; antagonist) inhibitor) inhibitor) Ofatumumab; Zarnestra; Bosutinib (Lymphocyt e inhibitor) NSCLC Erbitux; Sutent; Nexavar; Aflibercept; Iressa Tarceva Avastin Vadimezan; Telcyta; Figitumumab; Motesanib; (VRGF (TKI) (TKI) Antagonist) Pazopanib; Recentin; BIBW-2992; Enzastaurin; Zactima; Vargatef Colorectal Cancer Avastin (VRGF Antagonist); Vectibix Tarceva; Sutent; Aflibercept; Brivanib Erbitux (EGFR Antagonist) Alaninate; Recentin (EGFR Antagonist) Kidney Cancer Nexavar Torisel Sutent Avastin (B-raf (mTOR (VEGFR (VRGF Axitinib; Pazopanib; Anyara; Rencarex kinase Inhibitor) kinase Antagonist) inhibitor) inhibitor) Note: Late Stage Pipeline includes only those drugs which are either in Phase III or pre-registration stage of development Source: Grail Research; PharmaProjects database (accessed in August 2009) February, 2010 | Copyright © 2010 Grail Research, LLC 10
  • 11. 2 More aggressive use of utilization tools is underway Biologics in Breast Cancer – Usage of utilization tools in 2008 and expected increment in 2011a,2 Commercial health Medicare Managed Medicaid PBMs1 plans advantage plans plans Management Incremental Incremental Incremental Incremental strategy % of plans % of plans % of plans % of plans % of plans % of plans % of plans % of plans using the using the using the using the to use the to use the to use the to use the tool in 2008 tool in 2008 tool in 2008 tool in 2008 tool in 2011 tool in 2011 tool in 2011 tool in 2011 Quantity Limits 36.4% 14.5% 43.5% 17.4% 29.4% 23.5% 36.4% 27.3% Step Therapy 14.5% 23.6% 13.0% 30.4% 17.6% 23.5% 0.0% 36.4% Prior Authorization 56.4% 7.3% 60.9% 13.0% 52.9% 17.6% 36.4% 9.1% by Diagnosis Prior authorization 34.5% 21.8% 21.7% 30.4% 41.2% 11.8% 0.0% 36.4% by test results Coinsurance cost 29.1% 12.7% 56.5% 13.0% NA NA 18.2% 0.0% share Note: 1PBM is Pharmacy benefit management; 2Survey group include Commercial health plans (N=55), Medicare Advantage plans (N=23), Managed Medicaid plans (N=17), PBMs (N=11) Source: aBiotechnology Monitor and Survey, Marketplace Policies, Practices and Perspective: 2009 February, 2010 | Copyright © 2010 Grail Research, LLC 11
  • 12. The cost of cancer therapy is increasing as patients shift to 3 newer, more expensive therapies New drugs cost more and are increasing share Average Monthly Medicare Price of Drugs at the Time of Oncology Drugs Market Share by Launch, 1996–2007a Approval (1994-2008)b 100 8,000 Percent Market Share 7 12 18 8 14 27 21 27 6,465 36 31 35 6,000 37 USD 38 50 100 38 37 4,000 3,610 93 88 82 73 64 57 49 2,000 1,450 41 35 32 0% 0 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 1994-1998 1999-2003 2004-2008 Drugs Launched in 2003-07 Drugs Lanched in 1997 or Before Year of Approval Drugs Launched in 1998-02 Utilization of Newer therapies is increasing New Therapies cost more The Cost of Treating Cancer is Increasingc 100 75 Annual Cost of Treating Cancer 62 (USD Bn) 50 43 30 0 1990 1995 2000 2005 Source: a”The Oncology Pipeline: Maturing, Competitive, and Growing?’, Oncology Business Review, Sep 2008; b“Limits on Medicare's Ability to Control Rising Spending on Cancer Drugs”, NEJM Article, February 5, 2009; cManaged Care Oncology Magazine, Q3 2008 Issue February, 2010 | Copyright © 2010 Grail Research, LLC 12
  • 13. At the same time, drug benefits may seem modest relative 3 to cost Some of the newly-approved brands cost USD 150-500K per life year gained Incremental Cost / Life Year of Incremental Cost of Year Gained Drug Company Indication Approval Benefit Therapy (LYG) (USD) (USD)1 Avastina Roche Breast Cancer 2008 4 months survival 50,000 150,000 0.127 months Tykerbb GSK Breast Cancer 2007 21,484 169,165 survival 1.96 months Ixemprac BMS Breast Cancer 2007 30,900 189,184 survival Non-small Cell 345,757– Avastinb Roche 2006 2.3 months survival 66,270–80,343 Lung Cancer 419,181 OSI Pharmaceuticals / Pancreatic 364,680– Tarcevab 2005 0.4 months survival 12,156–16,613 Roche Cancer 498,390 Colorectal 1.44 months Erbituxb BMS 2004 21,954 182,950 Cancer survival Notes: 1LYG costs have been derived Source: aNew York times; bAmerican Society of Clinical Oncology (ASCO); cJournal of Clinical Oncology February, 2010 | Copyright © 2010 Grail Research, LLC 13
  • 14. This has led to a new and public discussion about the 3 cost/benefit of these new therapies Commentary in the press New York Times, July 2008 - Cost effectiveness of Avastin - “It’s absolutely critical that we start having a public discussion,” said Barbara Brenner, executive director of Breast Cancer Action, an advocacy group. “I think of Avastin as a model that is showing us where the problem is.”a Bloomberg News, June 2009 - “Eli Lilly & Co.’s tumor-fighter Erbitux doesn’t prolong lung cancer patients’ lives enough to justify its $80,000 cost, U.S. scientists said in commentary published today. Erbitux added to other cancer drugs extends survival about 1.2 months more than chemotherapy alone, making the price too high for a ‘marginal benefit,’ commentary in the Journal of the National Cancer Institute said”b Medscape, May 2009 - “Ixabepilone (Ixempra) for metastatic breast cancer is an example of a cancer drug that adds ‘a small benefit at a high cost,’ says an editorial in the May 1 edition of the Journal of Clinical Oncology. The editorial accompanies a new cost-efficacy study in the same issue of the journal that found that the addition of ixabepilone to capecitabine (Xeloda) adds about $31,000 to the overall medical costs of metastatic breast cancer while providing about 1 more month of ‘quality-adjusted’ survival”c The Independent, August 2008 - “The National Institute for Health and Clinical Excellence (NICE) issued draft guidance rejecting the drugs Sutent (sunitinib), Avastin (bevacizumab), Nexavar (sorafenib) and Torisel (temsirolimus)” “The guidance rejects the drugs because they are not cost effective”d The Wall Street Journal, March 2009 - “Expert advisers in the U.K. are sticking with their view that GlaxoSmithKline’s Tykerb is too costly to justify routine use in women with advanced breast cancer. The British government’s National Institute for Health Effectiveness, or NICE, put out a final appraisal that said Tykerb hadn’t ‘demonstrated that it was cost effective’ in comparison with other treatments. It put forth a similar view last summer”e Sources : a“Costly Cancer Drug Offers Hope, but Also a Dilemma”, The New York Times, July 6, 2008; b “Lilly Erbitux Cancer Drug Not Worth Price, U.S. Scientists Say”, Bloomberg News, June 2009; c“Ixabepilone in Metastatic Breast Cancer: Small Benefit at High Cost”, Medscape, May 2009; d“NHS denies 'effective' cancer drugs due to cost”, The Independent, August 2008; e“U.K. Says Tykerb Isn’t Worth Cost, Even With 12 Free Weeks”, The Wall Street Journal, March 2009 February, 2010 | Copyright © 2010 Grail Research, LLC 14
  • 15. 3 Companies are reacting with price caps… Examples of price cap initiatives  If patients spend more than 5%  Genentech capped Avastin at of their annual gross income on USD 55,000/year for patients with In Oct. 2006, In Sept. 2006, copayments, then they become a household income less than Genentech Amgen eligible for free drugs through an $75,000 a yeard announced a instituted a assistance programb price cap on price cap on Avastin based Vectibix at on a patient’s $4,000 per dose incomea (20% lower than BMS’s Erbitux)d Price Caps Employed In May 2006, as a Tool The UK BMS government announced a (NICE) uses  Patients who spend over USD price cap on cost/benefit  A threshold of GBP 30,000 per 10,000/month become eligible Erbitux for analysis in quality-adjusted life year for free or discounted drugs patients that evaluating (QALY) is used in evaluating through a charitable programa reach a drugsc drugs for reimbursementc monthly threshold Sources : a”Contracting, rebating, risk-sharing – IMS Conference hears about more innovative approaches to pricing”, IMS Global Insights; b“Managed Care Best Practices in Oncology Management”, Conference report, November 2006; c“Cost-Effectiveness of Cancer Drugs Is Questioned”, The Wall Street Journal, June 2009 and “Time to Consider Cost in Evaluating Cancer Drugs in United States?”, Medscape Today, July 2009 ; d“Top Of The Cancer Market?”, Forbes, October 2006 February, 2010 | Copyright © 2010 Grail Research, LLC 15
  • 16. 3 … and pay for performance arrangements Drug companies are increasingly offering discounts to insurers based on drug performance rather than quantity of drug utilized1 Pay for Performance Examples  In 2001 Pfizer convinced the State of Florida to put all its drugs on the state's Medicaid formulary. In return Pfizer agreed to rebate a portion of drug costs if its drugs failed to generate long-term cost savings across the healthcare systema • This model worked for Pfizer, enabling the company to avoid up-front discounts and back-end rebates, while saving the State of Florida USD 41.9MM in other healthcare costsa  In 2007, after the NHS in Britain decided not to pay for the cancer drug Velcade, Johnson & Johnson offered a money-back guarantee if Velcade failed to reduce tumors by at least 25%b,c • Through this Pay for Performance strategy, the NHS designated Velcade as cost-effective for up to four cycles of treatmentc  In 2007, United Healthcare entered into a risk sharing agreement with Genomic Health. The company sells Oncotype DX®, a USD 3,460 genetic test that determines whether an early-stage breast cancer patient would benefit from chemotherapyc • United Healthcare agreed to pay for the test for 18 months, on grounds that it would seek a price negotiation if the test failed to have the intended medical impactc  In 2009, in response to a negative UK NICE appraisal, Merck offered to refund the primary care cost of its drug Erbitux, if a patient did not respond within 6 weeksd  In 2009, when Tarceva was declared cost ineffective by NICE, Roche offered a rebate for the cost difference between Tarceva and the incumbent NSCLC treatmentd Note: 1Pay for Performance is more popular in Europe.US, insurers have less leverage with drug makers because of tough state regulations and marketplace pressures Source: ; a“Money-Back Guarantee”, Pharmaceutical Executive, April 2008; b“Drug Deals Tie Prices to How Well Patients Do”, New York times, April 2009; c“Pricing Pills by the Results”, New York times, July 2007;d “More Velcade-Style Risk-Sharing In The UK?”, Europharmatoday.com, January 2009; February, 2010 | Copyright © 2010 Grail Research, LLC 16
  • 17. Companies are also conducting head-to-head trials in order to 3 demonstrate superiority for their agent over alternatives The crowded market is resulting in increased pressure on drug companies to conduct head- to-head trials to prove that their product is better than the competitor’s product Expected Completion Comparison Condition Trial Sponsor Date Results were expected Zactima vs Second line NSCL in September 2009; Astrazeneca Tarcevaa Cancer Regulatory submissions withdrawn Recentin vs First line metastatic Astrazeneca May 2011 Avastina Colorectal Cancer Sutent vs. First line metastatic Pfizer Halted in June 2009 Avastin1,b Breast Cancer Sprycel vs Bristol-Myers First line CML Complete Gleevec2,c Squibb Tykerb vs Adjuvant Breast GlaxoSmithKline May 2013 Herceptina Cancer Note: 1Trial halted in June 2009 as better survival rates could not be established; 2FDA approved Sprycel for treatment of CML since the study established better survival rates in Gleevec- resistant patients. The drug fulfills the need for second line treatment Source: aClinicaltrial.gov, b“Pfizer halts Sutent breast-cancer trial”, fiercepharma.com, June 2009; c“FDA Grants Full Approval For SPRYCEL For The Treatment Of Adults With Chronic Myeloid Leukemia”, MedicalNewsToday, May 2009 February, 2010 | Copyright © 2010 Grail Research, LLC 17
  • 18. 4 Greater use of oral therapeutics is changing oncology Unlike the overall industry, orals are gaining share in Oncology Percentage of Worldwide Rx & OTC Pharmaceutical Sales from Share of Biologics Within Top Biotech vs. Conventional Technologya 100 Products 100 91 91 90 89 88 87 86 84 83 82 81 80 79 78 77 80 2014 50% Technology % of Rx & OTC Sales 60 2008 28% 40 18 19 20 21 22 23 14 16 17 20 9 9 10 11 12 13 2000 11% 0 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009E 2010E 2011E 2012E 2013E 2014E 0% 10% 20% 30% 40% 50% 60% Biologics Conventional Oncology Market for Targeted Therapies: Biologics vs. Conventional Technologyb 100 100 74 % of Total Sales 80 69 66 60 31 34 40 26 20 0 0 2000 2006 2010E 2015E Conventional Biologics Source: aWorld Preview 2014, May 2009, Evaluate Pharma report; bMonthly oncology report, October 22, 2007, Rodman and Renshaw equity research February, 2010 | Copyright © 2010 Grail Research, LLC 18
  • 19. 4 Oral oncologics are managed using traditional utilization tools… Traditional tools such as tier status, prior authorization, quantity limits and co-payments are being adopted for oral oncologics Formulary Status of Oral Oncology Brandsa,1 2,000 Number of PDPs covering drugs 1,645 1,648 1,648 1,648 1,648 1,648 34 34 34 34 34 1,500 204 417 417 417 417 417 1,000 882 879 879 873 877 1,444 500 41 207 174 210 274 275 36 2 2 109 2 148 2 108 2 0 Glivec Sutent Tarceva Thalomid Tykerb Tamoxifen Tier 6 Tier 5 Tier 4 Tier 3 Tier 2 Tier 1 % of Plans with Primary Tier % of Plans: % of Plans: Primary Cost- Drug Drug on Formulary Placement Prior Authorization Quantity Limits Sharing Range Gleevec 100% 4 70% 29% 26% - 35% Sutent 100% 4 62% 32% 26% - 35% Tarceva 100% 4 62% 32% 26% - 35% Thalomid 100% 4 68% 25% 26% - 35% Tykerb 100% 4 74% 42% 26% - 35% Tamoxifen 100% 1 0% 2% $ 0 - $10 Note: 1Selected drugs include Glivec, Sutent, Tarceva, Thalomid, Tykerb and Tamoxifen (Data from November 2008 for Medicare Part D plan) Source:a“Cost Sharing for Cancer Patients in Medicare, 2009”, Avalere Health and American Cancer Society Cancer Action Network, December 2008 February, 2010 | Copyright © 2010 Grail Research, LLC 19
  • 20. 4 … and this trend is increasing over time PDP’s are increasing the use of traditional utilization tools such as prior authorization and co-payments PDP’s1 Requiring % Coinsurance Amount, 2006-2009a Prior Authorization, 2006–2009a 80 76 35 33 33 33 33 Enrollment-Weighted Average 71 71 72 30 30 30 30 31 Coinsurance Amount (%) 68 68 67 30 30 64 30 29 29 60 63 62 27 28 27 27 28 28 PDPs requiring Prior 60 57 55 authorization (% ) 53 25 48 46 40 41 42 20 40 15 10 20 5 0 0 Gleevec Sutent Tarceva Thalomid Tykerb2 Gleevec Sutent Tarceva Thalomid Tykerb2 2006 2007 2008 2009 2006 2007 2008 2009  PDPs are increasing the use of prior authorization to  PDPs are shifting the cost burden to the patients by control access to branded cancer drugsa,b gradually increasing co-insurance amounts for • However, the administrative burden of obtaining brand-name oral anticancer drugsa prior authorization is high, and the process is time- consuming for payers and providersb Note: 1PDP’s are Prescription Drug Plans; 22006 data omitted for Tykerb because the Food and Drug Administration (FDA) approved the drug in March 2007 Source: a“Cost Sharing for Cancer Patients in Medicare, 2009”, Avalere Health and American Cancer Society Cancer Action Network, December, 2008; b“Oncology trends report”, NCCN February, 2010 | Copyright © 2010 Grail Research, LLC 20
  • 21. Table of Contents  Historical Market Dynamics  Evidence of Changes  Case Studies  How to Prepare February, 2010 | Copyright © 2010 Grail Research, LLC 21
  • 22. Case Studies: Close But Not Yet  We are clearly seeing different dynamics in the oncology market than we have historically  However, we have not yet seen significant competition driven solely by pricing. This is a scenario which could emerge when there are multiple, largely equivalent agents available in the marketplace  To date, potential competitive situations (Erbitux vs Vectibix, Nexavar vs Sutent and Tykerb vs Herceptin) have resolved quickly with clear winners based on clinical data, labeling, and physician preference (not payor pressure) February, 2010 | Copyright © 2010 Grail Research, LLC 22
  • 23. Case Study 1 – Vectibix position to displace the similar Erbitux was thwarted by clinical data Erbitux vs Vectibix Scenario at Launch What Happened?  Erbitux was launched by BMS/Imclone in 2004 for metastatic  In March 2007, Amgen discontinued a trial of Vectibix due to 231 colorectal cancer patients1 cases of death or disease progression. Vectibix sales in the second  Vectibix was launched in September 2006 by Amgen for metastatic quarter of 2007 fell from USD 51MM to USD 46MMe,f colorectal cancer patients2  Erbitux maintained steady growth even after the launch of Vectibix • Analysts expected that Vectibix would replace Erbitux as a • The total number of patients treated with Erbitux increased in treatment for colon cancera,b October 2007, and market share rose to 14.8% in that month g  Both Vectibix and Erbitux are antibody-based therapies that are • Vectibix did not show any month-to-month market share administered intravenously; however Vectibix had a few potential increase (in October 2007) and was underperforming according advantages to analystsg • More convenient (every other week) administration and lower  In 2009, label changes for both Erbitux and Vectibix were cost (20% discount) compared to Erbituxb implemented; these are expected to narrow the eligible pool of • Lower frequency of infusion reactions (1% compared to 3% for patients for both the drugs by up to 40%h Erbitux) i,j  Sales of Vectibix in 2006 (Oct-Dec) were USD 39MM and the company was upbeat about the futurec  Analysts at Merrill Lynch predicted that Vectibix would eventually take 60% of Erbitux's market. They also lowered their projected sales figures for Erbitux for 2008-2010d Note: 1Approved as a single agent for EGFR-expressing metastatic colorectal cancer after failure of both irinotecan- and oxaliplatin-based regimens or in patients who are intolerant to irinotecan-based regimens OR used in combination with irinotecan, EGFR-expressing metastatic colorectal carcinoma in patients who are refractory to irinotecan-based chemotherapy; 2Approved as a single agent for the treatment of metastatic colorectal carcinoma with disease progression on or following fluoropyrimidine, oxaliplatin, and irinotecan chemotherapy regimens Source: aPress release, September 27, 2006, Amgem company website; b“Vectibix Will be EGFR Antibody of Choice for Colon Cancer Therapy”, October 6, 2006, GLG group website; cAnalyst conference summary of Amgen quarter results, January 27, 2007, Openicon website; d”Amgen wins approval for colorectal cancer drug”, September 28, 2006, Marketwatch website; e”Amgen Discontinues Vectibix(TM) Treatment in PACCE Trial Evaluating Vectibix(TM) as Part of Triple Combination Regimen”, March 23, 2007, Biotechnoloogy-europe website; fPress Release, July 26, 2007, Pfizer company website; g“Monthly oncology regimen report through September 2007”, Rodman & Renshaw, Inc.,October 22, 2007; h“New US labelling for Erbitux and Vectibix recommends against their use for large subset of colorectal cancer patients”, July 20, 2009, Scripnews website; i"Vectibix(R) Now Available For The Treatment Of Advanced Colorectal Cancer In Belgium, October 03, 2008, Medicalnewstoday website; jErbitux website " February, 2010 | Copyright © 2010 Grail Research, LLC 23
  • 24. Case Study 2 – In another potential head-to-head battle, physicians chose Sutent over Nexavar Nexavar vs Sutent Scenario at Launch What Happened?  Nexavar was launched by Bayer/Onyx in December 2005 for  Sutent rapidly captured over 50% market share in renal cell advanced renal cell carcinomaa,2 carcinoma for all lines of therapy (July 2006)d  Sutent was launched by Pfizer in 2006 for the same • Sutent became the standard therapy for first-line indication1 treatment of mRCC after launche;  Direct competition was expected: • Nexavar competed more successfully in second line • Datamonitor forecasted Nexavar revenues would therapy with 35.1% patients receiving Sutent and reach USD 122MM and Sutent would reach USD 32.4% receiving Nexavar (October 2007)d 179MM by 2010b • Although Nexavar had a first-to-market advantage, Renal Cell Carcinoma Market share Sutent was expected to have superior efficacye 100 (All stages/ All lines)d Nexavar 80 Sutent • Nexavar on the other hand, was expected to have better tolerability – side-effects were limited mainly to 54 53 53 53 55 55 56 Market Share % 60 52 51 51 51 51 blistering and rashesc 34 32 32 34 34 32 33 33 34 33 33 33 40 • Cost of treatment was similar for both Sutent and Nexavar at USD 4,600 per treatment/monthd 20 0 06/2006 08/2006 10/2006 12/2006 02/2007 04/2007 06/2007 Note: 1Sutent is a kinase inhibitor indicated for the treatment of: (i)Gastrointestinal stromal tumor after disease progression on or intolerance to imatinib mesylate (ii) Advanced renal cell carcinoma; 2Nexavar is a kinase inhibitor indicated for the treatment of advanced renal cell carcinoma Source: aPress Release, December 20, 2005, Company website; b”Stakeholder Opinions: Renal Cell Carcinoma - Novel Targeted Treatments to Fill the Void”, December 2005, Researchandmarkets report; c”FDA approves Bayer's kidney cancer drug”, December 22, 2005, Pharmafocus Website; d”Torisel: The New Kid on the Block for Advanced Renal Cell Carcinoma”, September 2007, Oncbiz website; e”Nexavar and Sutent, Both Indicated for Metastatic RCC, Look Set to Compete Well to the End of the Decade - Nexavar's 2010 Revenues Are Forecast to Reach $122 Million and Sutent's $179 Million”, February 13, 2006, Business Wire February, 2010 | Copyright © 2010 Grail Research, LLC 24
  • 25. Case Study 3 – Tykerb could not displace Herceptin without more data and a better label Tykerb vs Herceptin Scenario at Launch What Happened?  Herceptin was the first targeted therapy to be launched for the treatment of  Tykerb reported modest global sales of USD 145.3MM in 2008d breast cancer in 1998 • Sales were far behind Herceptin’s, which recorded global sales of USD  Tykerb (oral therapy) was launched in 2007 as combination therapy with 1.82 billion in 2008h capecitabine (Xeloda), for the treatment of patients with advanced or  Factors contributing to Tykerb’s limited revenues were: metastatic breast cancer (mBC) with HER2 over-expression and who • In August 2007, a study conducted by Decision Resources suggested progressed on prior therapy including an anthracycline, a taxane, and that oncologists did not prefer Tykerb as a replacement for Herceptin. Herceptine Instead they were only using it as an alternative for Herceptin-refractory • Tykerb was approved in a second or third line settingk patients in the treatment of advanced breast cancerk • At the time of launch, GSK marketed Tykerb as a more convenient and • 58% of oncologists opined that they would favor IV Herceptin over user-friendly oral therapyg Tykerb because the administration of IV drugs remains an important  Expectations for Tykerb were mixed at the time of launch: source of income for their practicec • Some analysts expected the drug to achieve blockbuster status by  To boost revenues from Tykerb in breast cancer, the company decided to 2010a. Analysts assumed that drug would be effective in difficult to treat expand use of Tykerb in an adjuvant setting: patients and patients with brain metastases, Tykerb was expected to • As of April 2007, GSK was studying Tykerb for its application in adjuvant gain share in first line and adjuvant settings. breast cancer : "We are dedicated to the further study and development • Others predicted Tykerb’s use would be limited until it demonstrated of Tykerb in a variety of settings, including adjuvant breast cancer as significant benefits when added to Herceptin. well as in other solid tumor types“j • Analysts forecasted Tykerb sales to reach USD 104 MM1 in 2008b -Paolo Paoletti, MD, Oncology Medicine Development Center,GSK  At the time of launch, analyst expected the biggest sales opportunity for • GSK launched a head-to-head trial of Tykerb versus Herceptin in Tykerb to be in the adjuvant setting in the breast cancer marketb adjuvant breast cancer in 2008. Results for this trial are expected by May 2013f • In April 2009, GSK submitted an application to expand Tykerb use for first-line treatment of metastatic breast canceri Note: 1Reported as £ 62 million, conversion factor used as on November 16, 2009 Source: a“Analysts raise NPVs of Promacta and Rezonic; Tykerb still star of GSK oncology pipeline”, Goliath Business News, July 2007 ; bBear Stearns report September 21, 2007; cPR News wire August 14, 2007; dGSK Annual Report, 2008; Grail analysis; eDrugs @ FDA; fClinicaltrial.gov; gkomenozark.org; hGenentech Website; iGSK press release; j“Tykerb Approved for Metastatic HER2+ Breast Cancer “, cancernetwork.com, April 2007; k“Glaxo's Tykerb still has some convincing to do”, Evaluate Pharma, March 2008 February, 2010 | Copyright © 2010 Grail Research, LLC 25
  • 26. Table of Contents  Historical Market Dynamics  Evidence of Changes  Case Studies  How to Prepare February, 2010 | Copyright © 2010 Grail Research, LLC 26
  • 27. Preparing for a New Dynamic  While direct, payor-driven competition among oncology agents has not yet arrived, manufacturers need to be prepared for changes in the oncology market  Manufacturers may want to conduct head-to- head trials, or define market subsets where they can demonstrate superiority to potential alternative agents  Manufacturers may also want to consider scenarios where there are multiple agents with similar therapeutic profiles available for a given indication February, 2010 | Copyright © 2010 Grail Research, LLC 27
  • 28. For More Information Contact:  Grail Research (info@grailresearch.com) Copyright © 2010 by Grail Research, LLC No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means — electronic, mechanical, photocopying, recording, or otherwise — without the permission of Grail Research, LLC February, 2010 | Copyright © 2010 Grail Research, LLC 28