タンパク薬剤のデリバリー発展動向

Abstract

Introduction

Despite their remarkable success, protein drugs continue to suffer from important drawbacks, especially with respect to their delivery (subcutaneously or intravenously injected). Improvements in protein drug delivery will increase patient compliance and expand many drug markets. In addition, some new formulations may be patentable and can therefore extend a drug' s life cycle. For these reasons, pharmaceutical and biotechnology companies are researching and testing new delivery methods for protein drugs.

Get the Answers You Need to Shape Your Strategy

• Although protein-based drugs have had great commercial success, they still suffer from signifi cant drawbacks, especially in the area of delivery. What are these drawbacks and what are the barriers for creating better protein drug delivery methods?
• Many companies see the potential for improving the delivery methods for protein-based drugs. What companies are at the forefront of these improvements?
• Researchers are approaching this opportunity from several different angles. Some companies are looking to modify drugs to improve pharmacokinetics while other companies are developing whole new technologies. What are the specifi c programs and development initiatives in place? What is the time line for the introduction of these improved drugs and/or delivery devices?

Scope

• Milestones: Recent approval of two large-molecule drugs (Fortical and Exubera) that do not require injection show proof-of-principle that noninjected protein and peptide drugs can be developed successfully
• Modifi cation and discovery of protein drugs: Pegylation, fusion proteins, amino acid substitution or omission.
• Discovery and development of novel modifi ed proteins: novel pegylated protein drugs, novel fusion protein drugs, and novel bioengineered protein drugs
• Novel delivery methods in development: oral delivery, buccal delivery, transdermal systems, subcutaneous implants, pulmonary delivery, intranasal delivery
• Outlook: status of current programs, anticipated product launches, outlook for protein drug market.

Companies Mentioned in This Spectrum Report

• Aegis Therapeutics
• Aerogen
• Alkermes
• Altea Therapeutics
• Alza
• Amgen
• Amylin Pharmaceuticals
• Apogee Technology
• Aradigm
• Bayer
• Biovitrum
• Chrysalis Technologies
• DOR BioPharma
• Eli Lilly
• Emisphere Technologies
• Enzon
• Generex
• Georgia Tech Research Corporation
• GlaxoSmithKline
• Human Genome Sciences
• Intranasal Therapeutics
• Johnson & Johnson
• Macrofl ux
• MannKind
• MicroCHIPS
• Nautilus Biotech
• Nektar Therapeutics
• Novartis
• Novo Nordisk
• Pfi zer
• Prolong Pharmaceuticals
• Roche
• Sandoz
• Sanofi -Aventis
• Schering-Plough
• Spherics Pharmaceuticals
• Syntonix Pharmaceuticals
• Takeda
• UCB Pharma
• Unigene Laboratories
• Upsher-Smith
• Wyeth Pharmaceuticals

Table of Contents

• Strategic Considerations
  • Stakeholder Implications
• Introduction
• Recent Milestones in Protein Drug Delivery
• Modifi cation of Protein Drugs to Improve Pharmacokinetics
  • Pegylation
  • Fusion Proteins
  • Amino Acid Substitution or Omission
• Discovery and Development of Novel Modifi ed Proteins
  • Novel Pegylated Protein Drugs
    • Nektar Therapeutics
    • Prolong Pharmaceuticals
  • Novel Fusion Protein Drugs
    • Human Genome Sciences
    • Syntonix Pharmaceuticals
  • Novel Bioengineered Protein Drugs
• Transdermal Systems and Subcutaneous Implants
  • Transdermal Delivery
    • Macrofl ux
    • Apogee Technology
    • Altea Therapeutics
    • Peptide Chaperone for Transdermal Delivery
    • MicroCHIPS
• Oral and Buccal Delivery
  • Unigene
  • Emisphere Technologies
  • Spherics Pharmaceuticals
  • Generex
  • DOR BioPharma
• Pulmonary and Intranasal Delivery
  • Pulmonary Insulin Products in Late-Stage Development
    • Alkermes/Eli Lilly
    • MannKind
    • Novo Nordisk
  • Emerging Pulmonary and Intranasal Drug Delivery Systems
    • Chrysalis Technologies
    • Aegis Therapeutics
• Outlook for Protein Drug Delivery

Tables:

• 1. Select Marketed Modifi ed Protein Drugs
• 2. Select Novel Modifi ed Protein Drugs in Development
• 3. Novel Transdermal Systems and Subcutaneous Implants
• 4. Novel Oral and Buccal Formulations of Protein and Peptide Drugs
• 5. Novel Pulmonary and Intranasal Formulations of Protein and Peptide Drugs

Figures:

• 1. Anatomy of the Skin
• 2. MicroCHIPS' s Implanted Drug Delivery Device
• 3. Schematic Representation of a Micelle and a Reverse Micelle