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Dealmaking and Industry Outlook: Antivirals

Published by: Decision Resources

Published: May. 7, 2009 - 26 Pages


Table of Contents


Executive Summary

Strategic Considerations

Stakeholder Implications

Viruses Cause Debilitating Human Diseases

Genomics and Antiviral Development

Current Anti-Infectives Markets

Major Companies

Top-Selling Brands

Impact of Combination Products

Gilead Sciences’ HIV Franchise

GlaxoSmithKline’s HIV Franchise

Antiviral Drug Classes

Herpes Polymerase Inhibitors

Nucleoside Analogue Reverse Transcriptase Inhibitors

Nucleoside Analogues

Neuraminidase Inhibitors

Other HIV Antiviral Classes

Antivirals in Clinical Development

Small Molecules

HCV Antivirals

HIV Antivirals

New Classes of Antivirals in Clinical Development

Biologics

Industry-Shaping Events

Recent Deals and Business Strategies

Alnylam and Cubist

Bristol-Myers Squibb and ZymoGenetics

GlaxoSmithKline and Pfi zer

GlaxoSmithKline and Santaris Pharma

Merck & Co. and Ranbaxy Laboratories

Pfi zer and Tacere Therapeutics

Roche and Metabasis Therapeutics

Market Drivers

New Mechanisms of Action

Improved Dosing and Patient Compliance

Dominance of Small Molecules Over Biologics

Emerging Markets

Emerging Viruses

Outlook


Tables

1. The Link Between Human Viruses and Disease

2. Gilead Sciences’ and GlaxoSmithKline’s Major Antiviral HIV Franchises, 2008

3. New Classes of Small-Molecule Antivirals in Clinical Development

4. Select Monoclonal Antibodies in Clinical Development as Antivirals, 2009

5. Select RNA-Based Therapeutics in Development as Antivirals

Figures

1. Growth in the Global Anti-Infectives Markets, 2007-2014

2. Major Companies Marketing Antivirals, 2008

3. Best-Selling Antiviral Brands, 2008

4. Small-Molecule Antivirals by Phase of Clinical Development, 2008

5. Market Share of HIV Antiviral Drug Classes, 2007

Abstract

Introduction

The infamous mutability of viruses has long challenged antiviral drug developers, but complete genome sequences are now known for thousands of viruses, and the viral proteins encoded in these sequences are being used as targets for novel antiviral development. Viruses originated early during the evolution of life and have survived by their ability to mutate key genetic sequences in order to evade the defense systems of their hosts.

However, the last 30 years have seen great strides in elucidating the link between viruses and the development and treatment of human diseases. In this report, we evaluate the landscape for antiviral drugs, including antivirals on the market and those in clinical development. We assess novel mechanisms of action, recent deals, industry- shaping events, and market drivers—all of which are important in shaping company business strategies.

Get the Answers You Need to Shape Your Strategy
  • Human viruses exist in many different forms and genetic types. What types of viruses exist? What novel mechanisms of action are being exploited in the development of antivirals? What novel fi rst-in-class antivirals are in development?
  • Life-cycle management strategies are very important in the antivirals industry. What are the major antiviral franchises? What strategies are these companies using to maintain their market dominance? Why are combination drugs so important?
  • The HIV antiretroviral market is dynamic and competitive, comprising more than two dozen agents from six classes. What are the most pressing needs in HIV antivirals? What are the promising emerging therapies? How will the market share of different classes of HIV antivirals change in the near term?
  • Because of the side effects of interferon and ribavirin therapies, responses occur in only approximately 40-50% of U.S. patients infected with HCV (genotype 1). What novel HCV therapies are in development?What is Bristol-Myers Squibb’s three-pronged approach to HCV?
  • Pfizer’s Research Technology Center’s CSO Arthur M. Krieg, M.D., says RNAi is “potentially a transformational technology for biopharma that makes it worthy of aggressive investment.” What RNA-based antivirals are in development? What RNA-based deals took place recently?
Scope
  • Viruses: 2008 Nobel Prize in medicine, viral genome sequences, viral targets, human immunodefi -ciency virus type 1 and type 2, herpesviruses, cytomegalovirus, Epstein Barr virus, herpes simplex virus type 1 and type 2, varicella zoster virus, human papillomavirus, respiratory syncytial virus, hepatitis B virus, hepatitis C virus, infl uenza virus A and B.
  • Antiviral markets: Total market size, major franchises, best-selling brands, major companies,blockbuster antivirals, promising HCV antivirals, promising HIV antivirals, fi rst-in-class antivirals in development, emerging markets, swine fl u antivirals.
  • Technologies: Biologics, monoclonal antibodies, recombinant proteins, vaccines, small-molecule drugs, RNA-based therapeutics, RNA interference, microRNAs, antisense, pro-drugs, nucleoside analogues, follow-ons, ribozymes, genetically altered stem cells, cell-delivered gene therapy.
  • Mechanisms of action: Polymerase inhibitors, nucleoside analogue reverse transcriptase inhibitors (NRTIs), neuraminidase inhibitors, CCR5 antagonists, non-nucleoside reverse transcriptase inhibitors (NNRTIs), fusion inhibitors, integrase inhibitors, protease inhibitors, RNA antagonists, oligonucleotide antagonists.
  • Strategies: Life-cycle management, fi xed-dose combinations, pegylation, overcoming drug resistance, drug cocktails, market drivers, novel drug classes.
  • Dealmaking: RNA-based deals, a $1.1 billion megadeal, copromotion, upfront payments, milestones, profi t sharing, codevelopment, novel interferons, human proof-of-concept, options.


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