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The Outlook for Cardiovascular Risk Factors



  The Outlook for Cardiovascular
  Risk Factors
  Epidemiology, market and pipeline analysis

                       Figure 1.1: Cardiovascular risk factors

                              Cardiovascular risk factors

         Immutable                        Changeable              Protective

              Age                          Hypertension         HDL cholesterol

            Gender                         Dyslipidemia            Exercise

         Family history                       Smoking              Estrogen

                                              Obesity         Moderate alcohol use





                                         Behavioral factors

    Source: The Outlook for Cardiovascular Risk Factors

   “The burden of cardiovascular disease on society will continue to rise as the
   overall population ages. At the global level, the number of older persons will increase
   from 606 million in 2000 to 1.9 billion in 2050.”

                          Defend and grow your market share by analyzing opportunities within
                                    the risk factors and limit the threat from your competitors
                                                                 with the help of this latest management report...
The Outlook for Cardiovascular Risk Factors
Epidemiology, market and pipeline analysis

           Table 6.19: Smoking cessation                                                                      The Outlook for Cardiovascular Risk Factors: Epidemiology, market and
                 Rx Pipeline, 2003                                                                            pipeline analysis, evaluates current and future growth prospects for
                                                                                                              pharmaceutical companies to 2008 in five major cardiovascular risk factors that
  Company                        Brand                             Generic/code Status
                                                                                                              can be moderated by pharmacotherapy; hypertension, dyslipidemia, diabetes,
  GlaxoSmithKline Zyban XL bupropion                                                Phase III                 obesity and smoking.
  Sanofi-Synthélabo n/a    rimonabant                                               Phase III
                                                                                    Phase III
  Roche                          Tempium                           lazabemide       (discontinued)
  Xenova                         TA-NIC                            n/a              Phase I                   In the US alone, the direct and indirect costs of cardiovascular disease (CVD) and
  Nabi                           NicVAX                            n/a              Phase I
                                                                                                              stroke in 2003 are estimated at almost $352bn. Reducing these costs by
  GlaxoSmithKline                n/a                               GW-468816        Phase I
  Sanofi-Synthélabo              n/a                               SL-25.1131       Phase I                   appropriately treating cardiovascular risk factors has become a major focus of the
  n/a = not available                                                                                         pharmaceutical industry and healthcare payors. Use this report to evaluate how
                                                                                                              pharmaceutical companies can exploit unmet needs in CV risk factor markets
 Source: The Outlook for Cardiovascular Risk Factors                                                          and benefit from substantial companies cost savings within R&D.

 “The overall smoking cessation market is expanding,
                                                                                                              This report sets out to define cardiovascular risk factors and how identifying links
 however, several unmet needs still exist. For example
   unmet needs in the nicotine abuse market revolve                                                           to them sooner, will lead to a decline in CVD, resulting in massive cost savings
around the deficiency of neurological treatments for the                                                      for both pharmaceutical companies and healthcare payors. Treating risk factors
  condition. This is likely to be the future direction of                                                     is preventive medicine at its most challenging and this report provides
         nicotine addiction drug developments...”                                                             insights into the risk factors that you need to add greater value to your
                                                                                                              R&D process and product pipelines.

Key findings in this report

                                                                                                              • The global anti-hypertensive market was worth approximately $36.8bn in
          Figure 4.9: Unmet needs in the                                                                         2002. As the only class to remain entirely patent protected, future growth
              treatment of diabetes
                                                                                                                 within the global anti-hypertensive market will be driven by the
       Type I diabetes                                                       Type II diabetes                    angiotensin receptor blockers.

          Drug delivery
             poor compliance
                                                                                   poor compliance
                                                                                                              • Pfizer is developing a single pill combination of Lipitor and its anti-
                                           Increasing importance

              Efficacy                                                     Adverse side effects                  hypertensive Norvasc. Currently in registration in the US, the product,
             poor compliance                                                       poor compliance

     Adverse side effects                                               Low education/awareness
                                                                                                                 branded Caduet, could generate sales of $1bn in 2008, although it is likely
                                                                                                                 that other combinations of statins and anti-hypertensives will eventually prove
             poor compliance                                               late diagnosis & poor compliance

   Low education/awareness                                                      Drug delivery
     late diagnosis & poor compliance                                              poor compliance               more effective.
     Glucose monitoring                                                    Glucose monitoring

                                                                                                              • The prevalance of diabetes is rising rapidly, up from 30 million globally
 Source: The Outlook for Cardiovascular Risk Factors
                                                                                                                 in 1985 to a forecast 300 million in 2005. This reflects growth of the aging
                                                                                                                 population, adoption of unhealthy diets, obesity and sedentary lifestyles.
  " A key unmet need in the treatment of diabetes, in
particular type I diabetes, is the limited choice of formu-
  lation. Insulin has been administered by injection for                                                      • The current obesity market is worth just less than $800m and has the
over 75 years, with many patients requiring three or four                                                        potential to expand to around $1.6bn by 2010. Expansion will primarily be
   injections per day. This is highly inconvenient and                                                           driven by the reimbursement and wider availability of anti-obesity therapies,
results in low patient compliance. Oral administration of
                                                                                                                 based on the growing realization that treatment leads to a reduction in
 insulin is preferable but difficult because, as a protein,
                                                                                                                 expensive co-morbidities and mortality.
                      insulin is readily digested...”
The answers to your questions...

                                                                                          • What is the current and future value of the commercial opportunities
           Table 3.8: Selected leading and new
             antidyslipidemic product sales,
                                                                                             associated with treating major cardiovascular risk factors?
                                                                                          • Which combination statins/anti-hypertensives have greatest sales potential?
              Sales ($m) sales ($m)
 Brand        Generic      Marketer        2001    2002    2003    2005     2008

                                                                                          • How are leaders of the dyslipidemia market protecting their products from
 Lipitor      atorvastatin Pfizer          6,448   7,972   9,203   10,887   11,187
 Zocor        simvastatin Merck & Co.      5,245   5,580   6,072   5,426    3,151
              pravastatin Squibb
              rosuvastatin AstraZeneca
                                                                            2,973            patent challenges?
 Zetia        ezetimibe    Plough          n/l     23      204     471      1,268

                                                                                          • Which non-injectable insulins will be first-to-market in the diabetes sector?

                                                                                          • Which pipeline anti-hypertensives are the most promising?
  Source: The Outlook for Cardiovascular Risk Factors

         "The global antidyslipidemic market was worth                                    • What impact will the landmark ALLHAT study have on treatment practices in
 $22,879m in 2002, up from approximately $11.1bn in                                          the hypertension market?
 1997. With the increasing prevalence of dyslipidemia
  and the introduction of third-generation statins and
other promising antidyslipidemics from 2002 onwards,
   the market is set to continue experiencing healthy
                   growth to over $32bn in 2008...”

Top 5 reasons to order your copy today...

 Figure 2.5: Global anti-hypertensive market                                              1. Identify growing commercial opportunities associated with
          segmented by class, 2002                                                           increased management of cardiovascular risk factors by
                                                                                             healthcare payors.
                       Centrally-acting, 1.5%
                          Diuretic, 4.7%
                                                                                          2. Quantify current and future patient potential in the seven
           Alpha blocker, 6.1%
 Beta blocker, 11.9%
                                                                   ACE inhibitor, 29.4%
                                                                                             major national markets.

                                                                                          3. Assess the impact of late-stage pipeline developments on
             ARB, 20.1%
                                                           CCB, 26.4%                        sales of your products.

                                                                                          4. Prepare to respond to forthcoming patent expiries of
Source: The Outlook for Cardiovascular Risk Factors                                          leading products.

      "The global anti-hypertensive market was worth
                                                                                          5. Compare in-house forecasts against leading and new
 approximately $36.8bn in 2002, indicative of a nearly
6% rise since 2001. These results are fairly impressive in
                                                                                             product sales to 2008 detailed in this report.
     view of the large size of the market and the high
 degree of generic penetration, with only one class of
              anti-hypertensive drugs, ARBs, retaining
                           full patent protection...”
Sample information from the report

Market analysis

The current hospital and retail obesity market is worth just less than $800m. As one of the fastest growth segments of the
pharmaceutical market, it has the potential to expand to around $1.6bn by 2010. Such expansion will primarily be driven
by the reimbursement and wider availability of anti-obesity therapies, based on the growing realization that treatment leads
to a reduction in expensive co-morbidities and mortality. However, value growth will be hindered by the expiry of the
current market leading drug’s (Xenical) US patent in 2004. Despite the market’s growth potential, few companies have
successfully managed to generate sales from the ethical drug treatment of obesity.

Drug therapy

There is an enormous potential for developing safe, inert and efficacious short- and long-term drug treatments for
obesity. Until this happens, physicians must treat obesity on an individual basis and allow patients who respond well to
current drug therapies and tolerate their adverse effects to continue to benefit from current pharmacotherapy.
However, scientists have established five classes of drugs that could potentially treat obesity and weight gain:

·   Appetite suppressants - drugs that act centrally on the noradrenergic and serotoninergic pathways in the brain
    to reduce hunger perception, increase satietyand inhibit food intake.
·   Fat absorption inhibitors - drugs that reduce energy intake through a peripheral route.

·   Metabolic enhancers - drugs that act through peripheral mechanisms to increase thermogenesis without the
    need for an increase in physical activity.
·   Fat mobilizers drugs - that act peripherally to reduce fat mass or decreasetriglyceride synthesis.

·   Gene therapy antibodies - that can induce adipocyte cell death.

Pipeline analysis

Weaknesses of existing therapies, the increasing prevalence of obesity and the opportunity to treat obese patients at
younger ages has provided the incentive for numerous companies to conduct R&D in this area. Several investigational
approaches to weight loss are currently being examined in clinical trials, ranging from the creation of new appetite
suppressants to agents that act as fat blockers and drugs that hasten burning of stored body fat. A considerable amount
of research is being expended on the class of drugs known as ß3-adrenergic receptor agonists (or ß3-agonists), which
offer expedited energy burning without additional physical exertion.

The low number of marketed and phase III anti-obesity drugs reflects the high scientific hurdles that pharmaceutical
companies have faced in developing truly novel and improved therapies. In contrast, the larger number of drugs in
phases I and II of development suggest not only that scientific advances are now being made, but that the
pharmaceutical industry has not been deterred from investing in this potentially lucrative market. New technologies have
enabled new targets for obesity drug development to be identified, some of which are derived from genome-based
research. However, the most exciting developments in this area are still undergoing preclinical trials (e.g. small-molecule
insulin mimetics).
Table of contents
The Outlook for Cardiovascular Risk Factors: Epidemiology, market and pipeline analysis

What is a risk factor?                                           Overview of diabetes
How do risk factors contribute to cardiovascular                    • Pathophysiology and etiology
disease?                                                         Epidemiology
    • Ethics and practicalities of preventive therapy            Drug therapy
    • Impact of an aging population                              Market analysis
                                                                 Outlook for the diabetes market
CHAPTER 2: HYPERTENSION                                             • Unmet needs
Classification of hypertension                                       - Drug delivery
Epidemiology                                                         - Efficacy
Drug therapy                                                         - Side effects
   • Impact of ALLHAT study on anti-hypertensive therapy             - Awareness and education
Market analysis                                                      - Glucose monitoring
   • Norvasc (amlodipine)                                            - Pipeline analysis
   • Cozaar/Hyzaar (losartan/losartan HCTZ)
   • Diovan/Co-Diovan (valsartan/valsartan HCTZ)                 CHAPTER 5: OBESITY
Outlook for the hypertension market                              Overview of obesity
   • Unmet needs                                                    • Pathophysiology and etiology
   • Pipeline analysis                                           Epidemiology
     - Benicar (olmesartan)                                      Drug therapy
     - Inspra (eplerenone)                                       Market analysis
     - Vanlev (omapatrilat)                                      Outlook for the obesity market
     - ALT-711                                                      • Improving long-term drug safety
                                                                    • Pipeline analysis
CHAPTER 3: DYSLIPIDEMIA                                              - Topamax (topiramate)
Overview of dyslipidemia                                             - Axokine
   • Which markers are the best indicators of                        - P57
      cardiovascular risk?
Epidemiology                                                     CHAPTER 6: SMOKING CESSATION
Drug therapy                                                     Overview of smoking cessation
   • Statins                                                        • Pathophysiology
   • Fibrates                                                    Epidemiology
   • Bile acid sequestrants/inhibitors                           Drug therapy
   • Nicotinic acid derivatives                                  Market analysis
   • Fish oil derivatives                                        Outlook for the smoking cessation market
Market analysis                                                     • Unmet needs
Outlook for the dyslipidemia market                                 • Pipeline analysis
   • Unmet needs                                                     - Zyban XL (bupropion)
   • Pipeline analysis                                               - Rimonabant
   • Livalo (pitavastatin)                                           - TA-NIC
   • Caduet (atorvastatin + amlodipine)                              - NicVAX
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