SPECIAL REPORT: Blockbusters Then and Now--Trends for Billion-Dollar Drugs

This publication has been discontinued on December 21, 2011.

Introduction

Abstract

Introduction

Small-molecule pharmaceutical manufacturers have had a rough year: 2007 saw the abrupt ending of the development of many highly anticipated blockbuster compounds. Now, many small-molecule companies are left with an aging portfolio of blockbuster products that are about to lose patent-protection-and a new-product pipeline that is insuffi ciently stocked with late-stage products to make up for lost blockbuster revenues. For at least the near-term, biotech companies now have the advantage in the blockbuster market: there is little-if any-threat to these companies' best-selling products from generics competition upon patent expiry.

Get the Answers You Need to Shape Your Strategy

• Each year from 1996 to 2006, with only one exception, Pfi zer or GlaxoSmithKline led all pharmaceutical companies in the number of blockbusters marketed. However, both smaller and midsize pharmaceutical and biotech companies also marketed products that attained $1 billion in sales during that time period. What implications does the rise of smaller and midsize companies hold for the blockbuster arena-and for the pharmaceutical industry as a whole?
• Although many Big Pharma companies will be losing patent protection on many of their blockbuster drugs in the upcoming years, one Big Pharma company is poised to make a splash in the blockbuster arena. Which company is this? What two drugs is this company developing that will likely achieve blockbuster status?
• Barring unexpected delays in development, Merck' s Isentress is expected to be the fi rst integrase inhibitor to reach the HIV market and thereby become a new blockbuster drug for Merck. Why might subsequent drugs in this class have a particularly diffi cult time breaking into the HIV market after Isentress has established a signifi cant presence?
• As with sales of small-molecule blockbusters, sales of biologics blockbusters are susceptible to both equivalent (generics) products and to "me too" drugs. Evidence is building, however, that suggests biologics blockbusters will ultimately have more staying power than small-molecule blockbusters. What factors may ultimately determine the longevity of biologics blockbusters?

Scope

• Retrospective: trends during the past 11 years (1996-2006) in the number of blockbusters, the companies producing blockbusters, and the therapeutic areas blockbuster drugs have addressed.
• Recently failed, highly anticipated blockbuster candidates: potential blockbuster compounds that were abruptly discontinued or withdrawn by Sanofi -Aventis, Pfi zer, and Neurochem.
• Upcoming patent effects on current blockbusters: patent expiry dates in each of the seven major markets for 2006' s best-selling prescription drugs in the world; the late-stage product pipelines of select Big Pharma companies in relation to the upcoming loss of patent protection for their blockbuster drugs.
• Emerging blockbusters: potential $1 billion compounds in late-stage development in each of five different therapeutic areas (metabolic diseases, cardiovascular disease, oncology, infectious diseases, psychiatric disorders).
• Outlook and conclusion: the post-Vioxx world; the looming threat of generics; the outlook for biologics blockbusters.
• Expert commentaries: detailed examinations by industry experts of three vital blockbuster issues: the threat of biosimilars to the sales of biologics blockbusters, Big Pharma' s aggressive pursuit of biologics licensing and acquisition agreements (written by Spectrum Program Manager Barbara Bolten, M.S., M.B.A., and the disaster with Pfi zer' s Exubera (written by Decision Resources Senior Analyst Donny Wong, Ph.D.).

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Introduction
• Retrospective: Pharmaceutical Blockbuster Trends Since 1996
  • Methodology
  • Trends in the Number of Blockbusters, 1996-2006
  • Trends in the Type of Drugs Achieving Blockbuster Status, 1996-2006
  • Trends in Companies Producing Blockbusters, 1996-2006
  • Trends in the Therapeutic Areas of Blockbusters, 1996-2006
• Examples of Recently Failed, Highly Anticipated Blockbusters
  • Sanofi -Aventis' s Acomplia (Rimonabant)
  • Pfi zer' s Torcetrapib
  • Neurochem' s Alzhemed (Tramiprosate)
  • Upcoming Patent Effects on Current Blockbusters
• Review of Emerging Blockbusters
  • Emerging Blockbusters to Treat Metabolic Disease
    • Novartis' s Galvus (Vildagliptin)
    • Merck' s Cordaptive (ER niacin and laropiprant)
  • Emerging Blockbusters for Cardiovascular Disease
    • Novartis' s Exforge (Amlodipine & Valsartan)
  • Emerging Blockbusters for Oncology
    • GlaxoSmithKline' s Tykerb (Lapatinib)
  • Emerging Blockbusters for Infectious Diseases
    • Merck' s Isentress (Raltegravir)
  • Emerging Blockbusters for Psychiatric Disorders
    • Wyeth' s Pristiq (Desvenlafaxine)
• Conclusion

Tables

• 1. Top Blockbuster Companies, 1996-2000
• 2. Top Blockbuster Companies, 2001-2006
• 3. Total Number of Blockbusters by Company, 1996-2006
• 4. Patent Expiries in Major Markets of the 10 Top-Selling 2006 Blockbusters
• 5. Development Status and Anticipated Launch Year of Emerging Blockbusters

Figures

• 1. Growth in Number of Blockbusters Worldwide, 1996-2006
• 2. Select Companies' Late-Stage Pipelines vs. Anticipated 2012 Patent Expiries
• 3. Number of Conventional-Technology Blockbusters vs. Biotechnology Blockbusters, 1996-2006
• 4. Number of Blockbusters by Therapeutic Area, 1996-2000
• 5. Number of Blockbusters by Therapeutic Area, 2001-2006
• 6. Prevalent Cases of Select Metabolic Diseases in the Major Markets, 2006
• 7. Major-Market Value of Select Metabolic Disease Segments, 2006
• 8. Major-Market Value of Breast and Renal Cancer Therapies, 2005
• 9. Prevalent Cases of Breast and Renal Cancer in the Major Markets, 2006
• 10. Major-Market Value of Bipolar and Major Depression Therapies, 2005
• 11. Prevalent Cases of Bipolar and Major Depression in the Major Markets, 2006
• A. Projected Growth in Biologics Sales, 2001-2010

Expert Commentaries

• Exubera: What Went Wrong?
• Biologics Blockbusters-Decreased Vulnerability to Biosimilars and "Me Too" Drugs Portends Better Prospects for Blockbuster Sales Sustainability
• Big Pharma' s Interest in Biotech: Will the Trend Continue or Do Troubles Lie Ahead?

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