Evolving Approaches for Protein Drug Delivery

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