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  •  PAGES

  •  DATE

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    $

  •  DATA EXHIBITS

    125


TABLE OF CONTENTS


   Pages :    | $

   Study Reliability And Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
  
   Quantitative Techniques & Analytics.....I-3
Product Definitions And Scope Of Study.....I-3
  
   Global Market Overview and Analysis .....II-1
1$100
   Evolution of Statins Market.....II-21$100
   Growth of Cholesterol Drug Market.....II-31$100
   US Spearheads Statin Market.....II-4
Statins Market is Under Prescribed.....II-4
Potent Statins Embrace Wider Scopes for Market Expansion.....II-4
1$100
   Lipids Gets Center-Stage in Biomedical Research.....II-5
Scientists Discover Gene Mutation Key for Lipid Control.....II-5
2$200
   Growth Drivers.....II-7
Novel Drug Classes Energizes the Statins Market.....II-7
Advent of Single-Pill Combination.....II-7
Increased Promotional Spending Fuels Up the Statin Market.....II-7
1$100
   Revised Treatment Guidelines Sparks Up the Lipid-Lowering Drugs.....II-8
Development of New Uses of Statins.....II-8
Generic Substitution to Bring Down Statin Therapy Costs.....II-8
Statin Therapy to Become Standard Practice in Hospitals.....II-8
1$100
   Generics and New Combinations Erode the Profitability of Branded Products.....II-9
Aging Population Growth to Augment Statins Market.....II-9
New Therapies and Indications Leverage Statins Market.....II-9
Challenges Faced.....II-9
Low Awareness Restrains Market Potential.....II-9
1$100
   Physicians Hold Back on Prescribing Statins.....II-10
Non-Observance of NCEP Guidelines by Physicians Restrains Market Growth.....II-10
Poor Patient Compliance with Lipid-Lowering Therapy.....II-10
1$100
   Baycol Withdrawal Tightens the Drug Approval Process of FDA.....II-11
Expanding Cholesterol Drug Market Leads to Increased Health Plan Costs.....II-11
1$100
   What is Cholesterol?.....II-12
Reverse Lipid Pathway (RLT).....II-12
Lipid-Lowering Drugs.....II-12
Statins.....II-12
1$100
   Drug Selection by Lipoprotein Profile.....II-131$100
   Non-Statins.....II-14
Complementary Products.....II-14
Ezetimibe (Zetia).....II-14
1$100
   Combination Therapy.....II-15
Future Lipid Regulators.....II-15
2$200
   Lipitor, Zocor & Pravachol Dominate Statins Market.....II-17
Erosion of Blockbuster Drug Sales.....II-17
Review of Available Branded Statins.....II-17
Mevacor (Lovastatin).....II-17
1$100
   Pravachol (Pravastatin Sodium).....II-18
Zocor (Simvastatin).....II-18
1$100
   Lescol (Fluvastatin Sodium).....II-191$100
   Lipitor (Atorvastatin Calcium).....II-201$100
   Crestor (Rosuvastatin Calcium).....II-21
Vytorin (Ezetimibe/Simvastatin).....II-21
1$100
   Pitavastatin.....II-22
Table 1: Worldwide Leading Branded Statins: A Synopsis.....II-22

Table 2: Leading Statins Brands Worldwide (2003-2005E): Market Share by Sales for Lipitor, Zocor, Pravachol, Mevacor, Lescol, and Crestor (Includes Corresponding Graph/Chart).....II-22
1$300
   Lipitor from Pfizer Remains the Highest Selling Brand.....II-23
Table 3: Preferred Statins of HMO Formularies (Includes Corresponding
  Graph/Chart).....II-23
Advicor to Overtake Lipitor and Zocor.....II-23
1$300
   Cost Comparison of Statins.....II-24
1$100
   Use of Statins for Treating Dyslipidemia.....II-25
Role of Statins in Hyperlipidemia.....II-25
Statin Therapy for Children with Familial Hypercholesterolaemia.....II-25
Statin Therapy for Treating Familial Hypercholesterolaemia.....II-25
1$100
   Statins Help to Prevent Cardiovascular Diseases.....II-26
Role of Statins Therapy for Treating Atherosclerosis.....II-26
Statin Therapy for Postmenopausal Women.....II-26
1$100
   Statins Helpful for Osteoporosis Treatment.....II-27
Statins Indicate Evidence of Preventing Cancer.....II-27
1$100
   Role of Statins in Preventing Multiple Sclerosis.....II-28
Efficacy of Statins to Lessen Risk of CHD in Diabetes.....II-28
Statins Shows Efficacy for Treating Hyperlipidemia in Older Patients.....II-28
1$100
   Efficacy of Statins & Aspirins to Prevent Heart Attacks.....II-29
Statins Help to Reduce the Progression of Aortic Stenosis.....II-29
Statins Help to Abstain Alzheimer’s Disease.....II-29
Role of Statin on DVT.....II-29
Statins Substitute Cyclosporin for Organ Transplantation.....II-29
1$100
   Statins Lowers Fracture Risk in Elderly.....II-30
Statins Found Unsafe Concurrently with Protease Inhibitors.....II-30
1$100
   Bile Acid Sequestrants.....II-31
Colesevelam HCl (WelChol).....II-31
1$100
   CholestaGel.....II-32
Nicotinic Acid (Niacin).....II-32
Fibric-Acid Derivatives (Fibrates).....II-32
1$100
   Clofibrate (Atromid-S).....II-33
Fenofibrate (Lipidil).....II-33
TriCor.....II-33
Gemfibrozil (Lopid).....II-33
1$100
   Fish Oil.....II-34
Estrogen Therapy.....II-34
Various Benefits of Non-Statins.....II-34
Significance of Fenofibrate in Reduction of Increased Plasma Homocysteine
  Levels.....II-34
1$100
   Gemfibrozil in Combination with Niacin Augments HDL Levels.....II-35
Gemfibrozil Alleviates Chances of Coronary Attack.....II-35
Low-Dose Nicotinic Acid Beneficial for Type 2 Diabetics.....II-35
Combination Therapeutic Products.....II-35
Impact of Zetia with Statins in Treatment for Cholesterol Reduction.....II-35
Zetia with Simvastatin Doubles CRP Reduction Level.....II-35
1$100
   Lipitor and Norvasc Combination for Coronary Events with Hypertension.....II-36
Combination of Simvastatin and Niacin Useful for CAD Patients.....II-36
Advicor (Niacin & Lovastatin) Helpful to Reduce Cholesterol Levels.....II-36
Atorvastatin and Fenofibrate Combo Reduce Lipid Levels in Type 2 Diabetes with
  CHD.....II-36
Mevacor and Aspirin Combination Reduces Risk of Colon Cancer.....II-36
1$100
   WelChol & Lipitor Combination Lessens LDL Cholesterol Level.....II-37
Cholestagel & Statins Combination Therapy Helps to Reduce LDL Cholesterol.....II-37
1$100
   NCEP Guidelines for Lipid Abnormalities.....II-38
Revised NCEP Guidelines for Adult Treatment Panel III (ATP III).....II-38
1$100
   Revised NCEP Guidelines for Adult Treatment Panel II (ATP II).....II-391$100
   American Diabetes Association (ADA) Clinical Guidelines.....II-40
FDA Stiffens Stand on the Generic Availability of Statins.....II-40
1$100
   IMPAX Obtains FDA Grant for Generic Version of Colestid®.....II-41
Merck/Schering-Plough Obtains FDA Approval for New Indication of ZETIA®.....II-41
Novartis to Acquire NeuTec Pharma.....II-41
Sankyo Pharma, Daiichi Pharma, Daiichi Medical Merge to form Daiichi Sankyo.....II-41
1$100
   Teva Obtains FDA Nod for Generic Pravastatin.....II-42
Abbott Teams Up with AstraZeneca for Combination Cholesterol Pill.....II-42
Merck, Schering-Plough Collaborate Over Combination Cholesterol Drug.....II-42
Yamanouchi Pharmaceutical Merges with Fujisawa Pharmaceutical.....II-42
Teva Acquires Dorom S.r.l of Pfizer.....II-42
1$100
   Merck/Schering-Plough Receives Approval for Inegy™ in Europe.....II-43
Industry Activity in Recent Past .....II-43
Micro Labs Introduces Statin Molecule.....II-43
AstraZeneca Sets Up Bulk Drug Manufacturing Plant.....II-43
Merck/Schering-Plough Receives EU Approval for EZETROL™ (ezetimibe).....II-43
1$100
   AstraZeneca Introduces Crestor in Canada and the Netherlands.....II-44
AstraZeneca Launches Crestor in the US Market.....II-44
AstraZeneca Offers Crestor in the UK, Holland and Sweden.....II-44
Merck/Schering-Plough Launches ZETIA™.....II-44
Alpharma Unveils Simvastatin Tablets.....II-44
AstraZeneca Receives Canadian Approval for Crestor.....II-44
Merck Obtains FDA Approval for Zocor 40mg Dosage.....II-44
1$100
   Novartis Receives FDA Approval for Lescol & Lescol XL.....II-45
AstraZeneca Bags European Approval for Crestor.....II-45
Pfizer Obtains FDA Approval for Lipitor.....II-45
Bristol-Myers Squibb Receives FDA Approval for Pravachol® 80 mg Dosage.....II-45
Merck/Schering-Plough Bags FDA Approval for Zetia (ezetimibe).....II-45
Andrx Obtains FDA Approval for Altocor.....II-45
1$100
   Teva Pharmaceutical Receives FDA Approval for Micronized Fenofibrate
  Capsules.....II-46
IMPAX Obtains Temporary FDA approval for Generic Fenofibrate Capsules.....II-46
Teva Pharmaceutical Receives Indefinite FDA Approval for Generic Pravastatin.....II-46
Nymox Obtains US Patent for Statin Drugs for Treating Alzheimer's Disease.....II-46
Kos Introduces its Dual Component Therapy Advicor™ in the US.....II-46
1$100
   Bal Pharma Launches Simvofix.....II-47
Biocon Receives FDA Approval for Manufacturing Lovastatin in India.....II-47
Laboratorios Belmac Receives Spanish Approval to Market Generic Simvastatin.....II-47
Mylan Gets FDA Approval for Lovastatin Tablets.....II-47
Purepac Pharmaceutical Receives FDA Approval for Lovastatin Tablets.....II-47
Cipher Obtains FDA and Canadian Approval to Conduct Trials of Finofibrate.....II-47
1$100
   Sankyo Pharma Launches WelChol in the US.....II-48
Novartis Introduces Lescol XL.....II-48
Warner-Lambert Bags Marketing Approval for Lipitor in Japan.....II-48
Fournier Releases Supralip Tablets for Hyperlipidaemia.....II-48
Merck Introduces High Dosage Zocor.....II-48
1$100
   Abbott Laboratories (USA).....II-49
Andrx Corporation (USA).....II-49
AstraZeneca (UK).....II-49
1$100
   Astellas Pharma,Inc.(Japan).....II-50
Bentley Pharmaceuticals (USA).....II-50
1$100
   Bristol-Myers Squibb (USA).....II-51
Daiichi Sankyo, Inc. (USA).....II-51
1$100
   Kos Pharmaceuticals (USA).....II-52
Merck (USA).....II-52
1$100
   Merck/Schering-Plough Pharmaceuticals (USA).....II-53
Novartis AG (Switzerland).....II-53
1$100
   Pfizer (USA).....II-54
Teva Pharmaceutical (Israel).....II-54
2$200
   Table 4: World Recent Past, Current & Future Analysis for Lipid Regulators (Statins) by Geographic Region/Country – US, Canada, Japan, Europe, and Rest of World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....II-56

Table 5: World 11-Year Perspective for Lipid Regulators (Statins) by Geographic Region/Country – Percentage Breakdown of Dollar Sales for US, Canada, Japan, Europe, and Rest of World Markets for Years 2000, 2005 & 2010.(Includes Corresponding Graph/Chart).....II-56
1$300
   A. Market Analysis.....III-1
Statins Market in the US.....III-1
1$75
   Table 6: PBM Drug Expenditures by Therapeutic Category in 2004 in the US (Includes Corresponding Graph/Chart).....III-2
Current and Upcoming Statins in the US- A Profile.....III-2
1$150
   Table 7: Price of Statins in the US Market.....III-3
Table 8: Leading Players in US Lipid Regulators Market (2003-2005E): Market Share of Merck, Pfizer, Astra, BMS, Abbott, Novartis, KOS, and Others (Includes Corresponding Graph/Chart).....III-3
1$150
   Table 9: Statin Prescriptions by Brand in the US (2003-2005E): Percentage Share Breakdown for Lipitor (Atorvastatin), Zocor (Simvastatin), Pravachol (Pravastatin), Mevacor (Lovastatin), Lescol (Fluvastatin) and Others (Includes Corresponding Graph/Chart).....III-4

Table 10: Branded Statins Market in the U.S (2003-2005E): Market Share of Leading Players- Pfizer, Merck, AstraZeneca, BMS, and Novartis (Includes Corresponding Graph/Chart).....III-4
1$150
   Table 11: Branded Statins Market in the U.S (2003-2005E): Market Share of Leading Brands by Value Sales for Lipitor, Zocor, Crestor, Pravachol, Lescol, and Mevacor (Includes Corresponding Graph/Chart).....III-5
Market Trends.....III-5
Increasingly Aggressive Guidelines Fuel up Statins Market.....III-5
Physicians Switch to Higher and More Costly Starting Dose of Statins.....III-5
Expansion of Treatment Population Charges the Statin Market.....III-5
1$150
   Merck’s Zocor to Become Leading Selling Prescription.....III-6
Improved Patient Compliance Energizes the Statins Market.....III-6
Marketer’s Increased Promotional Spending Sparks Up Statin Sales.....III-6
New Clinical Studies Outcome Fuels the Expansion of Statin Market.....III-6
Lipitor Dominates the Lipid-Lowering Drugs Market.....III-6
Crestor Launch Jeopardize Market Players.....III-6
1$75
   Generics, New Combination Therapies Gaining Momentum.....III-7
Government to Boost the Growth of Generics Industry.....III-7
Aging Population Drives the Statin Market Growth.....III-7
1$75
   US Non Statins Market: A Profile of Select Products.....III-8
Table 12: Leading Brands of Statin Combinations in the U.S (2004&2005E): Percentage Share Breakdown for Advicor and Zocor/Zetia (based on number of prescriptions)......III-8

Table 13: Leading Products of Generic Statins in the U.S (2005E): Market Share by Value Sales for Lovastatin, Simvastatin and Pravastatin (Includes Corresponding Graph/Chart).....III-8
1$150
   Table 14: Leading Product Types in the US Non- Statins Market (2003-2005E): Percentage Share Breakdown for Fibrates, Nicotinic Acid Derivative, Bile-Acid Sequestrant, and New Products (Includes Corresponding Graph/Chart).....III-9
List of Major Players in US Market for Lipid Regulators by Product Type.....III-9
1$150
   Strategic Corporate Developments.....III-105$250
   Product Innovations/Introductions in Recent Past.....III-152$100
   Leading Players/Market Leaders.....III-174$200
   B. Market Analytics.....III-21
Table 15: US Recent Past, Current & Future Analysis for Lipid Regulators (Statins and Non-Statins) by Product Segments – Statins and Non-Statins Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-21

Table 16: US 11-Year Perspective for Lipid Regulators (Statins and Non-Statins) by Product Segment –Percentage Breakdown of Dollar Sales for Statins and Non-Statins Markets for 2000, 2005 & 2010.....III-21
1$150
   A. Market Analysis .....III-22
Strategic Corporate Developments in Recent Past.....III-22
Product Innovation/Introduction in Recent Past.....III-22
1$75
   B. Market Analytics .....III-23
Table 17: Canadian Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-23
1$150
   A. Market Analysis .....III-24
Current and Upcoming Statins in Japan- A Profile.....III-24
Strategic Corporate Development.....III-24
Strategic Corporate Developments in Recent Past.....III-24
1$75
   Product Innovation/Introduction in Recent Past .....III-25
Leading Players.....III-25
1$75
   B. Market Analytics .....III-26
Table 18: Japanese Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-26
1$150
   A. Market Analysis.....III-27
Current and Upcoming Statins and their Patent Expiration Years in the EU.....III-27
Growth of Generics to Control Health Care Costs in Europe.....III-27
1$75
   Strategic Corporate Developments in Recent Past.....III-28
Product Innovation/Introduction in Recent Past .....III-28
1$75
   B. Market Analytics .....III-29
Table 19: European Recent Past, Current & Future Analysis for Lipid Regulators (Statins) by Geographic Region/Country – France, Germany, UK, Italy, Spain, and Rest of Europe Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-29

Table 20: European 11-Year Perspective for Lipid Regulators (Statins) by Geographic Region/Country – Percentage Breakdown of Dollar Sales for France, Germany, UK, Italy, Spain, and Rest of Europe Markets for Years 2000, 2005 & 2010. (Includes Corresponding Graph/Chart).....III-29
1$150
   A. Market Analysis.....III-30
Statins in France: A Brand Profile.....III-30
B. Market Analytics.....III-30
Table 21: French Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-30
1$150
   A. Market Analysis.....III-31
Patent Expiry Fuels Up Generic Competition in German Statins Market.....III-31
Statins in Germany: A Brand Profile.....III-31
Strategic Corporate Developments.....III-31
1$75
   B. Market Analytics.....III-32
Table 22: German Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-32
1$150
   A. Market Analysis.....III-33
Generic Substitute Fuels Up the UK Statins Market.....III-33
Statins in the UK: A Brand Profile.....III-33
1$75
   UK Encourages Generic Status for Statins.....III-34
Strategic Corporate Developments .....III-34
Leading Player/Market Leader.....III-34
1$75
   B. Market Analytics.....III-35
Table 23: UK Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-35
1$150
   Market Analysis.....III-36
Table 24: Italian Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-36
1$150
   A. Market Analysis .....III-37
Strategic Corporate Development in Recent Past.....III-37
B. Market Analytics .....III-37
Table 25: Spanish Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-37
1$150
   A. Market Analysis.....III-38
Product Innovation/Introduction in Recent Past .....III-38
Leading Player/Market Leader.....III-38
1$75
   B. Market Analytics.....III-39
Table 26: Rest of Europe Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-39
1$150
   A. Market Analysis.....III-40
Australia.....III-40
Australian Drug Market.....III-40
Drug Approval Process in Australia.....III-40
1$75
   India.....III-41
Market Overview.....III-41
Table 27: Market Potential of Select Statins in Generics Market in India- Atorvastatin, Pravastatin, Simvastatin and Lovastatin (In INR Billion) (Includes Corresponding Graph/Chart).....III-41
Efforts of Pharmaceutical Industry Paying Off.....III-41
1$150
   Growth Drivers.....III-42
Exploring Other Growth Opportunities.....III-42
Competitive Landscape.....III-42
1$75
   Outlook.....III-43
Product Innovation/Introduction in Recent Past .....III-43
Strategic Corporate Developments.....III-43
Strategic Corporate Developments in Recent Past .....III-43
1$75
   Historic Review.....III-44
Leading Players/Market Leaders.....III-44
1$75
   B. Market Analytics.....III-45
Table 28: Rest of World Recent Past, Current & Future Analysis for Lipid Regulators (Statins)- Annual Sales Figures in US$ Million for Years 2000 through 2010 (Includes Corresponding Graph/Chart).....III-45
1$150
    
 
 


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