1. Executive Summary
Amgen Inc 2008-2023
2. Introduction to Amgen Inc
2.1 Amgen is a Major Player in The World Pharmaceutical Market
3. Company Overview
3 Amgen is the Biotech Market Leader
3.1 Amgen is an S&P 500 Company and Listed on Various Stock Exchanges, Including NASDAQ
3.2 Amgen's History-Key Developments
3.2.1 1980-1990
3.2.2 1991-2000
3.2.3 2001-Present
3.3 Key Personnel
3.4 Key Therapeutic Areas
3.4.1 Cancer
3.4.2 Inflammation
3.4.3 Neurology
3.4.4 Metabolic Disorders
3.4.5 Haematology
3.5 Amgen Key Financials - Sales of $14.7bn in 2007
3.6 Most of Amgen Sales are Generated from Anti-Anaemic Preparations
3.7 Amgen's Leading Drug s- Top 10 Drugs Revenues Expand By 1% in 2007
3.8 Most of Amgen's Sales are Generated in North America
4. Amgen Leading Drugs World Market Analysis
4.1 Aranesp (darbepoetin)
4.1.1 Aranesp Sales Decline by 12.3% in 2007
4.1.2 US Aranesp Sales Decline in 2007
4.1.3 Aranesp Other International Markets Grow by 2% in 2007
4.1.4 Aranesp Sales Forecast 2008-2023
4.1.5 Development of Aranesp
4.2 Neulasta (pegfilgrastim)
4.2.1 Neulasta Experiences Steady Sales Since 2002
4.2.2 Neulasta/Neupogen Sales Rise By 7% in Q1 of 2008
4.2.3 Neulasta Geographical Sales
4.2.4 Neulasta Sales Forecast 2008-2023
4.3 Enbrel (etenecept)
4.3.1 Embrel Revenues Grew By 24% In 2007
4.3.2 Enbrel Geographical Sales
4.3.3 Enbrel Q1 2008 US Sales Nears Blockbuster Revenues
4.3.4 Enbrel Sales Forecast 2008-2023
4.3.5 Development of Enbrel
4.4 Epogen (Epoetin AlfaA) - Recombinant Human Erythropoietin Product
4.4.1 Epogen Experiences Variable Sales Volume Commencing 2004
4.4.2 Epogen’s 2008 Q1 Sales Decline by -11%
4.4.3 Epogen Sales Forecast, 2008-2023
4.5 Neupogen (filgrastim)
4.5.1 Neupogen Geographical Sales
4.5.2 Neupogen 2008 Q1 US Sales up by 9.3%
4.5.3 Neupogen Sales Forecast 2008-2023
4.6 Sensipar (Cinacalcet) is Amgen's Leading Hyperparathyroid Drug
4.6.1 Sensipar Sales Expand Year-On-Year Since Its Entry into the Market
4.6.2 Sensipar 2008 Q1 Sales Exceed $105m Reached During Same Period in 2007
4.6.3 Sensipar Sales Forecast 2008-2023
4.7 Amgen's Vectibix (panitumumab) - a Monoclonal Antibody (Mabs) Drug Adds to its Oncology Products
4.7.1 Vectibix from Abgenix -to-Immunex-To- Amgen
4.7.2 EMEA Grants Amgen's Vectibix a Conditional Market Authorisation in Europe
4.7.3 The US Market Accounted for all Vectibix Sales in 2006-2007
4.7.4 Vectibix Sales Forecast 2008-2023
4.8 Kineret (anakinra)
4.8.1 Kineret (anakinra) Sales Falls to $58m in 2007
4.8.2 Kineret Sales Forecast 2008-2023
4.9 Amgen Key Drugs Total Sales Forecast, 2008-2023
4.10 Amgen Will Recover from the Challenges of 2007
4.11 Amgen Corporate Revenue Forecast 2008-2023
5. Competitive Factors in Amgen's Market
5.1 Amgen's Key Competitor in Supportive Cancer Care and Oncology
5.2 Amgen's Key Nephrology Competitor
5.3 Amgen Competition in Inflammatory Therapeutics
5.4 Amgen's Key Metastatic Colorectal Cancer (mCRC) Drug's Competitor
5.5 Amgen's Faces Strong Competition from Rival Biotech Companies
5.5.1 Drugs of Biotech Origin Reached $40bn Mark in 2006
5.5.2 Genentech is Amgen Strongest Biotech Competitor
5.5.3 Merck KGaA Acquired Serono in 2007
5.5.4 Biogen Idec
5.5.5 Genzyme
5.5.6 AstraZeneca Acquire MedImmune in 2007
5.5.7 Gilead Science
5.5.8 UCB
5.9 CSL Limited
5.10 Cephalon Experiences 46% Sales Growth In 2006
5.11 Amgen Faces Mounting Pressure From Key Competitors
6. Amgen’s Market SWOT Analysis
6.1 The World Biopharmaceutical Market Continues to Grow, But Faces Mounting Challenges
6.2 The Continuing Success of International Biopharmaceuticals Companies is Dependent upon Important Drivers and Restraints
6.3 Companies are Gradually Changing their Strategic Focus to Overcome Challenges in the Worldwide Market
6.4 Reduced Efficiencies in R&D Result in Concerns over Thinning Pipelines
6.5 Driving and Restraining Forces Acting upon Amgen
6.5.1 A SWOT Analysis for Amgen
6.6 Biotech Blockbusters on the Rise
6.6.1 Biotechnology is an Important and Fast Growing Part of R&D
6.6.2 Amgen's Leading Drugs are Dominant in All Markets
6.7. Amgen Experience Turbulent End to 2007
6.7.1 FDA and Other Regulatory Bodies Recommend Changes to Erythropoietin Stimulating Agents (ESAs) Labels
6.7.2 FDA Monitors ESAs over Two Decades
6.7.3 Amgen Presents Six Randomised Trials Addressing Potential ESA Safety Concerns to the FDA In 2007
6.7.4 Amgen Updates Aranesp Package Label- CRDAC/DSaRMAC Recommend ESA Dosage Target Hb Levels Not Exceeding 11 g/dL
6.7.5 European Agency for the Evaluation of Medicinal Products (EMEA) Announces Upcoming ESA changes
6.8 Amgen's Aranesp US Third Quarter Sales Decline by 36% Following CMS ESAs Coverage Restrictions
6.9 Amgen Commences Worldwide Restructuring In Order to Improve Cost Efficiencies
6.9.1 Amgen is The New Victim Of Big Pharma's Corporate Resizing Strategy
6.9.2 Amgen Rationalises Network Manufacturing Facilities to Improve Cost Efficiencies
6.9.3 Amgen Has One of The Highest Industry R&D Investment Expenditure
6.9.3.1 Amgen Spends Nearly 20% of Annual Revenues On R&D
6.9.4 Amgen Will Continue to Thrive as Biotech Products Gain Increasing Recognition
6.10 Amgen's Business Model Reflects Success Despite Industry Challenges
6.11 FDA Approves Record Number of Biotech Drugs in 2006 Including Amgen's Vectibix
6.12 Amgen's Near-Term Patent Expiration on Key Products Will Create Commercial Opportunities for Expanding Biosimilars/ Generic Sector
6.13 Amgen Faces Revenue Challenges from Biosimilars (Biogenerics) Drugs Market
6.13.1 Generic Epoetin Influx in Unregulated Markets Rises
6.13.2 Biosimilars Approval Rises in The EU Market
6.13.3 The US Accounted for 15% of The Global Biological Drugs Market In 2006
6.13.4 Strong Bioequivalence Hurdles Will Regulate the Fast Market Entry of Biogenerics Drugs
6.14 Traditional Pharmaceutical Companies Crowd Biotech Market Share
6.14.1 Biotech Drugs Contributed Significantly to Big Pharma Revenues In 2006
6.14.2 Roche Gains Momentum in Amgen’s Territory
6.14.3 Big Pharma’s Bolstering of Thinning Pipelines Will Further Heighten Amgen’s Market Competition
6.14.4 Rising Regulatory Hurdles and High Cost of Developing Biologic Drugs Will Play to The Advantage of Big Pharma
6.14.5 Amgen Will Continue to Compete with Big Pharma’s Large Investment Trends in Biotech Drugs
6.15 Amgen Can Experience Significant Revenues in the Diabetic Market
6.16 Increasing Use of Pharmacoeconomic Evaluations Will Have an Impact on Amgen’s Future Revenues
6.17 The Growing Investor Interest in Pharmacogenomics Holds Revenue Prospects for Both Biotech and Big Pharma
6.17.1 Pharmacogenomics Holds Potential Benefits
6.17.2 Amgen Forges Way into Biomarker Application in Vectibix Trials
6.18 Will the Blockbuster Business Model Continue to Yield High Revenues for Amgen?
6.19 Amgen Will Drive Products Sales Through PLM
6.20 New Reformulation of Existing Products will be Significant to Amgen in the Face of Rising Competition
6.21 Amgen Will Need to Take More Commercial Risks
6.22 Increased Combination Therapies Will Expand Revenues Of Amgen's Specialist Products
6.23 The Need for Greater R&D Efficiency Will Remain One Of Amgen's Key Priorities
6.24 The Need for Amgen to Regain Trust of Healthcare Stakeholders is Imperative Following Changes in ESAs Labels
6.25 Inevitable Legal Hurdles Will Contribute to Amgen's Challenges
6.26 Amgen's Social Responsibility Programmes Will Retain Patient's Loyalty in the US
6.26.1 Amgen and Partner Jointly Establish Encourage Foundation for Enbrel
6.26.2 Amgen's Safety Net Foundation is One of the Most Benevolent Free Medical Schemes in the Pharmaceutical Industry
6.26.3 Amgen Launches Oncology Assistance Program in 2006- (Vectibix Cap)
6.26.4 Vectibix Cap Limits Patient Co-payment To 5% in the US
6.27 Amgen Like Other Companies Could Benefit From Changes to Patent Laws Risks
7. Amgen Mergers and Acquisitions (M&As) Activities
7.1 Amgen Acquires Ilypsa
7.2 Amgen Acquires Alantos
7.3 Amgen Completes Acquisition of Avida
7.4 Amgen Completes Acquisition of Abgenix
7.5 Amgen Completes Acquisition of Tularik
7.6 Amgen Completes Immunex Acquisition in 2002
7.7 Amgen Acquires Kinetix Pharmaceuticals Inc Acquisition in 2002
7.8 Amgen Acquires Synergen in 1994
8. Amgen's Key Licensing Agreements
8.1 Amgen's Joint Venture with Kirin Has Lasted Over Two Decades
8.2 Amgen and Kirin Transfers AMG 531 to KA
8.3 Amgen Grants Johnson & Johnson Recombinant Human Erythropoietin Licence
8.4 KA Licence Recombinant Human Erythropoietin To Johnson & Johnson and Another Product to Roche Outside The US
8.5 Amgen and Wyeth Co-Promote Enbrel
8.5.1 Wyeth to Reimburse Amgen under Three Clarified Conditions
8.6 Amgen Establishes its Own Venture in 2004
8.7 Amgen Enters Agreement with Yeda Research and Development
8.8 Amgen Enters a Five-Year Sole Sourcing and Supply Deal with Fresenius Medical Care North America Inc
8.9 Amgen and Cytokinetics Collaborate in Novel Small-Molecule Deal
8.9.1 Cytokinetics May be Eligible to Earn Milestone Payments of up to $600m from Amgen
8.10 Amgen Collaborates With Daiichi Sankyo to Commercialise Denosumab in Japan
8.11 Amgen and Takeda Pharmaceutical Enter Agreement
8.11.1 Takeda Will Become Amgen's Global Partner for Motesanimab Diphosphate (AMG 706)
8.12 Amgen Acquires Kyowa Hakko Kyowa’s Humanized Monoclonal Antibody (Anti-CCR4)
8.12.1 Kyowa Hakko Kogyo (KW-0761) has Oncology and Inflammatory Potential
8.13 Other Amgen Licenses Agreements
8.13.1 Amgen Collaborates with Human Genome Science
8.13.2 Amgen Collaborates with Oxford Genome Science
8.13.3 Amgen Collaborates with Alcon
8.13.4 Amgen And Galapagous Extend Deal Throughout 2006
8.13.5 Amgen And InterKrin Enter INT131 Licence Agreement
8.13.6 Amgen and Biovitrum Expand 11beta-HSD1 Licensing Deal
9. Amgen's Recent Litigation Proceedings
9.1 Amgen is Embroiled in Several Lawsuits with Johnson and Johnson
9.1.1 Johnson & Johnson's Ortho Biotech And Ortho-McNeil Pharma File Demand for Arbitration Against Amgen
9.1.2 Ortho Biotech Files AntiTrust Lawsuit Against Amgen
9.1.3 Ortho Biotech Files Spill Over Arbitration Litigation Against Amgen
9.2 Amgen Files a Lawsuit Against Roche
9.2.1 Amgen Succeeds in Erythropoietin Products Patent Challenge
9.3 Other Forthcoming Litigations
9.4 Cost of Litigations Will Impact on Revenue Growth
10. Amgen’s Pipeline
10.1 Amgen's Post-Marketing Studies Commitments
10.2 Recent ESA Studies Outcome
10.3 Amgen is Conducting Post-Marketing Research for Enbrel and Others
10.4 Amgen Has Over Thirty Molecules in its Pipeline
10.4.1 Amgen's Phase III Pipeline is Dominated by Oncology Molecules
10.4.2 Amgen's Phase II Pipeline is Dominated by Oncology Molecules
10.4.3 Amgen's Phase I Pipeline is Dominated by Inflammatory Molecules
10.5 Amgen's Oncology Pipeline
10.5.1 Vectibix (Panitumumab)
10.5.2 AMG 102 is A Fully Human Monoclonal Antibody
10.5.3 AMG 386 a recombinant Fc-Peptide Fusion Protein (Peptibody)
10.5.4 AMG 479 Mab Binds to Insulin-like Growth Factor-1 Receptor
10.5.5 AMG 655 is a Mab Antagonist Directed Against DR5 Receptor
10.5.6 Amgen and Genentech Collaborate on rhApo2L/TRAIL An Apoptotic Molecule
10.5.7 Motesanib Diphosphate
10.5.8 Romiplostim (Formerly Known as AMG 531)
10.5.9 Denosumab is Being Studied in Various Cancers
10.6 Inflammation Pipeline
10.6.1 AMG 108 Has Interleukin-1 (IL-1) Inhibitory Potential
10.6.2 AMG 317
10.7 Bone Disease Pipeline
10.7.1 Denosumab Targets Receptor Activator of Nuclear Factor Kappa B ligand
10.7.1.1 Denosumab Phase II Postmenopausal Osteoporosis Looks Promising
10.8 Amgen and UCB Collaborate on Sclerostin Ab (AMG 785) for Bone Loss
10.9 Metabolic Disorders Pipeline
10.9.1 Sensipar (Cinacalcet HCl)
10.10 General Medicine
10.10.1 Amgen Initiates Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT) Study
10.10.2 Amgen Conducts the Reduction of Events with Darbepoetin Alfa in Heart Failure (RED-HF) Study
10.10.3 AMG 223 Targets CKD Patients on Haemodialysis
10.11 Other Studies
10.11.1 Kepivance Head and Neck Carcinomas Study Underway
11. Conclusions
11.1 Amgen is a Top-20 Pharmaceutical Company with Innovative Human Therapeutic Products
11.2 Strategic Acquisitions Boosted Amgen's Product Portfolio
11.3 Most of Amgen Sales are Generated from Anti-Anaemic Preparations
11.4 The US Continues to be Amgen's Largest Market
11.5 From 2008-2012 Sales of Amgen's Leading Products Will Yield Strong Growth
11.6 Amgen's Key Licensing and Major Acquisitions Will Strengthened Its Pipelines in Time for Biogeneric Competitions
11.7 Amgen Can Remain at the Forefront of the Global Biotech Industry and Continue to be a Strong Competitor In the Pharmaceutical Market With Impressive Sales Worldwide
List of Tables
Table 3.1 Top 20 Pharmaceutical Companies, 2003-2007
Table 3.2 Amgen Revenues, 2003-2007
Table 3.3 Amgen Sales in Key Therapeutic Areas, 2007
Table 3.4 Amgen Top 10 Product Sales, 2007
Table 3.5 Amgen's Geographical Sales, 2007
Table 3.6 Amgen Sales by Country, 2007
Table 4.1 Amgen's Principal Products, 2005-2007
Table 4.2 Amgen's Principal Products, 2005-2007 (continued)
Table 4.3 Aranesp Sales Forecast, 2008-2023
Table 4.4 Neulasta Sales, 2007-2007
Table 4.5 Neulasta Sales Forecast, 2008-2023
Table 4.6 Enbrel Geographical Sales, 2005-2007
Table 4.7 Enbrel Sales Forecast, 2008-2023
Table 4.8 Epogen Sales Forecast, 2008-2023
Table 4.9 Neupogen Geographical Sales, 2005-2007
Table 4.10 Neupogen Sales Forecast, 2008-2023
Table 4.11 Sensipar Geographical Sales, 2005-2007
Table 4.12 Sensipar Sales Forecast, 2008-2023
Table 4.13 Vectibix Sales, 2007
Table 4.14 Vectibix Sales Forecast, 2008-2023
Table 4.15 Kineret Sales Forecast, 2008-2023
Table 4.16 Amgen’s Key Drugs Total Sales Forecast, 2008-2023
Table 4.17 Amgen: Total Corporate Sales, 2008-2023
Table 5.1 Amgen's Major Supportive Cancer Care and Oncology Competing Drugs
Table 5.2 Neulatsa/Neupogen Major Competing Drugs
Table 5.3 Amgen's Major Nephrology Competitors, 2007
Table 5.4 Amgen's Major Inflammatory Competitors, 2007
Table 5.5 Amgen's Competition With Rival Biotech Companies, 2006
Table 6.1 Amgen SWOT Analysis
Table 6.2 Amgen Employees, 1980-2007
Table 6.3 Amgen's R&D Investments, 1993-2007
Table 6.4 R&D By Capital Investment of Top 10 Pharmaceutical Companies, 2006
Table 6.5 Amgen's Products Position in the Top 20 Pharmaceutical Products, 2007
Table 6.6 Amgen Key Patent Expirations Over the Years Ahead
Table 6.7 Competing Biosimilar Epoietin Launched in 2007-2008
Table 6.8 Top 10 Companies in Biotech Sales, 2006
Table 10.1 Post Marketing Commitments
Table 10.2 ESA Studies Outcome
Table 10.3 Oncology Pipeline
Table 10.4 Inflammation Pipeline
Table 10.5 Bone Disease Pipeline
Table 10.6 Metabolic Disease Pipeline
Table 10.7 General Medicine Pipeline
Table 11.1 Amgen Sales in Key Therapeutic Areas, 2007
Table 11.2 Amgen Sales by Country, 2007
List of Figures
Figure 3.1 Top 20 Pharmaceutical Companies, 2003-2007
Figure 3.2 Top 20 Pharmaceutical Companies Market Share, 2007
Figure 3.3 Amgen Revenues, 2003-2007
Figure 3.4 Amgen Net Income, 2003-2007
Figure 3.5 Amgen Sales in Key Therapeutic Areas, 2007
Figure 3.6 Amgen Key Therapeutics Share, 2007
Figure 3.7 Amgen Top 10 Drugs Market Share, 2007
Figure 3.8 Amgen's Geographical Sales , 2007
Figure 3.9 Amgen Sales by Country Share, 2007
Figure 4.1 Aranesp Sales, 2002-2007
Figure 4.2 Aranesp Geographical Sales, 2005-2007
Figure 4.3 Aranesp Geographical Share, 2005-2007
Figure 4.4 Aranesp Sales Forecast, 2008-2023
Figure 4.5 Neulasta/Neupogen Combined Sales, 2002-2007
Figure 4.6 Neulasta/Neupogen Combined Share, 2007
Figure 4.7 Neulasta Geographical Sales, 2005-2007
Figure 4.8 Neulasta Geographical Share, 2005-2007
Figure 4.9 Neulasta Sales Forecast, 2008-2023
Figure 4.10 Enbrel Sales, 2002-2007
Figure 4.11 Enbrel Geographical Sales, 2005-2007
Figure 4.12 Enbrel Geographical Share, 2007
Figure 4.13 Enbrel Sales Forecast, 2008-2023
Figure 4.14 Epogen Sales, 2002-2007
Figure 4.15 Epogen Sales Forecast, 2008-2023
Figure 4.16 Neupogen Global Sales, 2002-2008
Figure 4.17 Neupogen Geographical Sales, 2005-2007
Figure 4.18 Neupogen Geographical Share, 2007
Figure 4.19 Neupogen Sales Forecast, 2008-2023
Figure 4.20 Sensipar Sales, 2005-2007
Figure 4.21 Sensipar Geographical Sales, 2005-2007
Figure 4.22 Sensipar Geographical Share, 2007
Figure 4.23 Sensipar Sales Forecast, 2008-2023
Figure 4.24 Vectibix Sales, 2006-2007
Figure 4.25 Vectibix Sales Forecast, 2008-2023
Figure 4.26 Kineret Sales Forecast, 2008-2023
Figure 4.27 Amgen’s Key Drugs Total Sales Forecast, 2008-2023
Figure 4.28 Amgen: Total Corporate Sales, 2008-2023
Figure 5.1 Amgen's Major Inflammatory Competitors, 2007
Figure 5.2 Amgen's Biotech Market Share, 2006
Figure 6.1 Amgen Employees, 1980-2007
Figure 6.2 Amgen's R&D Investments, 1993-2007
Figure 6.3 R&D Expenditure for Top 10 Pharmaceutical Companies, 2006
Figure 6.4 Market Share of Top 20 Pharmaceutical drugs, 2007
Figure 6.5 FDA Drug Approvals, 2006
Figure 6.6 Top 10 Companies in Biotech Sales, 2006
Figure 6.7 Top 10 Companies in Biotech Share, 2006
Figure 7.1 Amgen Mergers and Acquisitions Time-Line
Figure 8.1 Amgen's Key Licensing and Partnership, 1984-2008
Figure 10.1 Overview of Amgen's Pipeline
Figure 10.2 Number of Molecules Per Disease/Condition Area in Amgen’s Pipeline
Figure 11.1 Amgen Sales in Key Therapeutic Areas, 2007
Figure 11.2 Amgen Sales by Country Share, 2007
Figure 11.3 Number of Molecules Per Disease/Condition Area in All Clinical Phases