The Fastest Growing Biotechnology Companies: Growth strategies, comparative analyses and company profiles

Table of Contents

Executive Summary

• Summary of key findings
• Comparitive analyses of growth strategies
• Theravance, Inc - company profile and analysis
• ISTA Pharmaceuticals - company profile and analysis
• Palatin Technologies - company profile and analysis
• Pharmion Corporation - company profile and analysis
• Amylin Pharmaceuticals - company profile and analysis
• Trimeris, Inc - company profile and analysis
• ViroPharma Inc - company profile and analysis
• NPS Pharmaceuticals - company profile and analysis
• SIGA Technologies, Inc - company profile and analysis
• Idenix Pharmaceuticals - company profile and analysis

Chapter 1 Key findings and industry analysis

• Summary
• Overview of the biotechnology sector
• Recent developments
• Current applications
• Structure of the biotechnology industry
• The pharmaceutical-biopharmaceutical relationship
• Emergence of the biopharmaceutical sector
• Characteristics of the biopharmaceutical industry
• Collaborative corporate environment
• Highly technology and intellectual property
• High venture capital investment
• High risk and costs associated with drug development
• Identifying fast growth companies- Methodology
• Purpose and value of the analysis
• Candidates identified as fast growth companies

Chapter 2 Comparitive analyses of growth strategies

• Summary
• The Fastest Growing Biopharmaceutical Companies
  • The evolving nature of the biopharmaceutical industry
• Comparative analysis of R&D strategies
• Revenue versus R&D expenditure
  • Early Phase R&D Strategies
  • Late Stage Clinical Development
  • Sponsored Research Payment Strategies
• Analysis by Therapeutic Area
• Comparative analysis of commercialization strategies
  • Platform positioning
• The modern extended biopharmaceutical enterprise
• Comparative analysis of manufacturing strategies
• Comparion of restructuring and cost containment strategies
• Case Study: Downsizing R&D at Trimeris, Inc.

Chapter 3 Theravance, Inc.

• Summary
• Company address and contact details
• Company overview and history
• Business profile
• Discussion and analysis of financial data
• Source and details of income
• Review of proprietary technologies
• Patents and proprietary rights
• Strategic approach and positioning
• Strategic approach
• SWOT Analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Joint ventures, collaborations and M&A activity
• Theravance' s collaboration with GlaxoSmithKline (GSK)
• License, development and commercialization agreement with Astellas
• License agreement with AstraZeneca AB
• Product development programs
• Bacterial infections
  • Telavancin
  • TD-1792
• Respiratory
• Horizon program (formerly Beyond Advair)
  • Inhaled bifunctional muscarinic anatgonist-beta2 agonist (MABA) program
  • Inhaled long-acting muscarinic antagonist (LAMA) program
  • Gastrointestinal motility disorders
• Research programs

Chapter 4 ISTA Pharmaceuticals, Inc.

• Summary
• Company Address and Contact Details
• Company overview and history
• Business profile
• Discussion and analysis of financial data
• Source and details of income
• Review of proprietary technologies
• Patents and proprietary rights
• Strategic approach and positioning
• Strategic approach
• SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Joint ventures, collaborations and M&A activity
• Xibrom, Istalol, Bepotastine, Ecabet Sodium, Latanoprost and Iganidipine
• collaborations with Senju
• Vitrase commercialization outside the US
• Collaboration with Otsuka Pharmaceutical
• Marketed products
• Xibrom™ (bromfenac)
• Istalol®
• Vitrase®
• Product development programs
• T-Pred (tobramycin and prednisolone acetate combination product)
• Bepotastine
• Ecabet sodium
• Strong steroid product

Chapter 5 Palatin Technologies Inc

• Summary
• Company address and contact details
• Company overview and history
• Business profile
• Discussion and analysis of financial data
• Source and details of income
• Review of proprietary technologies
• Patents and proprietary rights
• Strategic approach and positioning
• Strengths
  • Strength in MC expertise
• Weaknesses
  • Termination of collaborative agreement with King Pharmaceuticals
  • Limited product pipeline portfolio
• Opportunities
• Threats
• Joint ventures, collaborations and M&A activity
• Strategic alliance with AstraZeneca AB
• Collaborative development and marketing agreement with King
• Pharmaceuticals
• Strategic collaboration agreement with Mallinckrodt
• Product development programs
• Bremelanotide (formerly PT-141)
  • Male sexual dysfunction (MED)
  • Female sexual dysfunction (FSD)
• Development of novel natriuretic receptor compounds

Chapter 6 Pharmion Corporation

• Summary
• Company address and contact details
• Company overview and history
• Business profile
• Discussion and analysis of financial data
• Source and details of income
  • Review of proprietary technologies
  • Patents and proprietary rights
• Strategic approach and positioning
• Strengths
  • Vidaza: potential future growth and revenue opportunities
  • Formation of strategic alliances
• Weaknesses
  • Lack of manufacturing capabilities
• Opportunities
  • Acquisition by Celgene
  • Inorganic growth
  • FDA approval of Vidaza NDA supplement for IV administration
• Threats
  • Litigations
  • Intense competition
  • Cost containment pressures
• Joint ventures, collaborations and M&A activity
• M&A history
  • Acquisition of Cabrellis Pharmaceuticals
• Joint ventures and collaborations
• Marketed products
• Vidaza (azacitidine for injection)
• Thalidomide Pharmion
• Innohep
• Refludan
• Product development programs
• Amrubicin
• Oral azacitidine
• Satraplatin
• MGCD0103

Chapter 7 Amylin Pharmaceuticals, Inc.

• Summary
• Company address and contact details
• Company overview and history
• Business profile
• Discussion and analysis of financial data
• Source and details of income
  • Review of proprietary technologies
  • Patents and proprietary rights
• Strategic approach and positioning
• Strengths
  • Strategic alliances
  • Byetta
  • New management team
• Weaknesses
  • Reliance on third party manufacturers
  • Narrow customer concentration
• Opportunities
  • Exenatide (long acting release) LAR
  • INTO obesity program
• Threats
  • Competition
• Joint ventures, collaborations and M&A activity
• Joint ventures and collaborations
• Marketed products
• Byetta (exenatide) injection
• Symlin
• Product development programs
• Diabetes product development
  • Exenatide LAR program
• Obesity product development program
  • Pramlintide
  • Pramlintide and Leptin
  • Pramlintide PYY 3-36

Chapter 8 Trimeris, Inc.

• Summary
• Company address and contact details
• Company overview and history
• Business profile
• Discussion, analysis of financial data
• Details of income
  • Review of proprietary technologies
  • Patents and proprietary rights
• Strategic approach and positioning
• Strengths
  • Collaboration with Roche
  • Fuzeon
• Weaknesses
  • T-1249 on hold
• Opportunities
  • HIV drugs market
  • TRI-1144
  • Strategic shift in the company' s focus
• Threats
  • Market acceptance of Fuzeon
  • Intense competition
• Joint ventures, collaborations and M&A activity
• Joint ventures and collaborations
• Marketed products
• Fuzeon
• Product development programs
• FUZEON
• T-1249
• Next generation fusion inhibitor peptide drug candidates

Chapter 9 ViroPharma Inc.

• Summary
• Company address and contact details
• Company overview and history
• Business profile
• Discussion and analysis of financial data
• Source and details of income
• Review of proprietary technologies
• Patents and proprietary rights
• Strategic approach and positioning
• Strengths
  • Strategic partnerships
  • Fast track status
• Weaknesses
  • Lack of manufacturing capabilities
  • Customer concentration
• Opportunities
  • Camvia™ (maribavir)
• Threats
  • Dependence of continued sales of Vancocin
• Joint ventures, collaborations and M&A activity
• Joint ventures and collaborations
  • Cytomegalovirus and GlaxoSmithKline
  • Hepatitis C and Wyeth
  • Vancocin capsules and Eli Lilly
  • Picornaviruses and Schering-Plough Corporation
• Marketed products
• Vancocin
• Product development programs
• Camvia™ (maribavir)
• HCV-796
• NTCD (non-toxigenic C. difficile)
• Antiviral discovery

Chapter 10 NPS Pharmaceuticals Inc.

• Summary
• Company Address and Contact Details
• Company overview and history
• Business profile
• Discussion and analysis of financial data
• Source and details of income
  • Review of proprietary technologies
  • Patents and proprietary rights
• Strategic approach and positioning
• Strategic approach
  • Outsource non-core competencies
  • Build a diversified pipeline of products addressing a variety of
  • medical conditions
  • Collaborate or out-license to reduce risk and accelerate the
  • commercialization of select product candidates
• SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Joint ventures, collaborations and M&A activity
• Joint ventures and collaborations
  • Amgen Inc
  • AstraZeneca
  • GlaxoSmithKline
  • Janssen
  • Kirin Brewery of Tokyo (pharmaceutical division)
  • Nycomed
• Marketed products
• Sensipar®/Mimpara® (Cinacalcet HCI)
• Preotact™ (PREOS®)
• Product development programs
• Teduglutide (ALX-0600)
• Calcilytics
• Glycine reuptake inhibitors (GlyT-1)
• Metabotropic glutamate receptors (mGluRs)

Chapter 11 SIGA Technologies, Inc.

• Summary
• Company address and contact details
• Company overview and history
• Business profile
• Discussion and analysis of financial data
• Source and details of income
• Review of proprietary technologies
• Patents and proprietary rights
• Strategic approach and positioning
• SWOT analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Joint ventures, collaborations and M&A activity
• Collaborative research and licenses
• Product development programs
  • Anti-infectives
  • Anti-smallpox drug
  • Other antivirals in development
  • Junín
  • Lassa fever
  • Ebola/Marburg
• HTS discovery campaign
  • Dengue
  • Bunyavirus
  • Sortase

Chapter 12 Idenix Pharmaceuticals, Inc.

• Summary
• Company address and contact details
• Company overview and history
• Business profile
• Discussion and analysis of financial data
• Source and Details of Income
  • Review of proprietary technologies
  • Patents and proprietary rights
• Strategic approach and positioning
• Strategic approach
  • Focusing on HCV and HIV drug discovery and development
  • programs only
  • Discontinuation of the HBV franchise
  • Trimmed workforce
• SWOT Analysis
  • Strengths
  • Weaknesses
  • Opportunities
  • Threats
• Joint ventures, collaborations and M&A activity
• Joint ventures and collaborations
• Marketed products
• Tyzeka®/Sebivo® (telbivudine)
• Product development programs
• IDX-899
• IDX184

Chapter 13 Appendix

• Methodology statement
• Primary Data and Information Gathering
• Secondary data and information gathering
• Market share analysis and market forecast predictions
• Definitions of Product-Life Cycle stages
• Glossary of abbreviations and acronyms
• Index

List of Figures

• Figure 1.1: Evolution of the biopharmaceutical corporation
• Figure 2.2: Analysis of R&D expenditure v revenues, 2006
• Figure 2.3: Sponsored Research Payment Strategies
• Figure 2.4: Sponsored research payment strategies
• Figure 2.5: The principles of the extended enterprise
• Figure 5.6: Disease area focus, Palatin Technologies
• Figure 5.7: Annual product history, Palatin Technologies
• Figure 7.8: Annual product history, Amylin Pharmaceuticals
• Figure 7.9: Product pipeline, Amylin Pharmaceuticals
• Figure 8.10: Annual product history, Trimeris
• Figure 8.11: Product pipeline, Trimeris
• Figure 9.12: Annual product history, ViroPharma
• Figure 10.13: Annual product history, NPS Pharmaceuticals
• Figure 10.14: Product pipeline, NPS
• Figure 10.15: Disease area focus, NPS Pharmaceuticals
• Figure 11.16: Annual product history, SIGA Technologies
• Figure 11.17: Product pipeline, SIGA Technologies
• Figure 12.18: Annual product history, Idenix Pharmaceuticals
• Figure 12.19: Product pipeline, Idenix Pharmaceuticals List of Tables
• Table 1.1: Top 20 pharmaceutical companies ranked by revenues (2006)
• Table 2.2: Summary analysis of the fastest growing biopharmaceutical companies, 2006 ($m)
• Table 2.3: Fastest growing biopharmaceutical companies by net income/loss from operations, 2002-06 ($m)
• Table 2.4: The top 20 biopharmaceutical companies by revenue in 2006 ($m)
• Table 2.5: Summary analysis of fastest growing biopharmaceutical companies 2006 ($m)
• Table 2.6: Fastest growing biopharmaceutical companies by revenues and % growth, 2002-06 ($m)
• Table 2.7: Fastest growing biopharmaceutical companies by R&D expenditure, 2002-06 ($m)
• Table 2.8: Company Analysis: Proprietary Technology versus Therapeutic Area
• Table 2.9: Fastest growing biopharmaceutical companies by revenues and % growth, 2002-06 ($m)
• Table 2.10: Company analysis by approved marketed product
• Table 3.11: Company address and contact details
• Table 3.12: Theravance Income Statement, 2002-2006 ($ millions)
• Table 3.13: Theravance product development programs
• Table 4.14: Company address and contact details
• Table 4.15: ISTA Income Statement ($ millions 2002-2006)
• Table 4.16: ISTA marketed product sales ($ millions 2005-2006)
• Table 4.17: ISTA product development and pipeline
• Table 5.18: Company address and contact details
• Table 5.19: Palatin Income Statement ($ millions) year ended June 30, 2003-2007
• Table 5.20: Palatin product development and pipeline
• Table 6.21: Company address and contact details
• Table 6.22: Pharmion Income Statement ($ millions 2002-2006)
• Table 6.23: Pharmion marketed product sales ($ millions, 2002-2006)
• Table 6.24: Pharmion product development and pipeline
• Table 7.25: Company address and contact details
• Table 7.26: Amylin Pharmaceuticals Income Statement, ($ millions, 2002-2006)
• Table 7.27: Amylin Pharmaceuticals Income Statement ($ millions, 2002-2006)
• Table 7.28: Amylin Pharmaceuticals product development and pipeline
• Table 8.29: Company address and contact details
• Table 8.30: Trimeris Income Statement ($ millions 2002-2006)
• Table 8.31: Trimeris product development and pipeline
• Table 9.32: Company address and contact details
• Table 9.33: ViroPharma Income Statement ($ millions, 2002-2006)
• Table 9.34: ViroPharma product development and pipeline
• Table 10.35: Company address and contact details
• Table 10.36: NPS Pharmaceuticals Income Statement ($ millions 2002-2006)
• Table 10.37: Marketed products
• Table 10.38: Marketed products
• Table 10.39: NPS Pharmaceuticals product development and pipeline
• Table 11.40: Company address and contact details
• Table 11.41: SIGA Technologies Income Statement ($ millions, 2002-2006)
• Table 11.42: SIGA Technologies- issued patents as of December 31, 2006
• Table 11.43: SIGA Technologies provisional patents and patent applications as of Dec 31, 2006
• Table 11.44: SIGA Technologies product development and pipeline
• Table 12.45: Company address and contact details
• Table 12.46: Idenix Pharmaceuticals Income Statement ($ millions, 2002-2006)
• Table 12.47: Idenix Pharmaceuticals product development and pipeline