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Evolving Approaches for Protein Drug Delivery

Published by: Decision Resources

Published: Aug. 27, 2007 - 24 Pages


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


Abstract

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 significant 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 specific 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 modified 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.


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