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Protein and Peptide-based Therapeutics - Trends in Drug Discovery and Development

Executive Summary

A Promising Future for Protein and Peptide Medications.

Since being recognised in the 1950's, many protein and peptide based therapeutics have been discovered. However, it is only over the last decade that developments have really drawn the attention of the pharmaceutical industry, states a new report by healthcare experts GBI Research.

According to the report*, there are currently 280 protein and peptide-based therapeutics molecules (excluding antibodies) currently being marketed for the treatment of a huge variety of diseases, ranging from cancer to HIV and hepatitis. This group of products is approved for the treatment of 283 indications across 22 therapeutic areas.

This total, however, may witness a boom in coming years, as GBI Research has identified 571 molecules in the discovery, preclinical and clinical stages of development. Even this considerable figure is likely to be an underestimate as companies do not always disclose this information. These recorded compounds exist in 953 indication-specific developmental programs, and 629 programs are currently in clinical development.

These therapy types are highly promising as they exert a high level of specificity on their respective targets, which can make them much more effective than traditional treatments. Their potential is increased by their high safety profiles and the high level of tolerance that patients exhibit to their application.

Protein and peptide therapies are not without their disadvantages, however. The size of these molecules poses substantial challenges as it can adversely affect intestinal uptake when the medication is administered orally. There are also issues regarding their half-life values and stability, with their tendency to be quickly hydrolyzed by plasma enzymes.

The cost of developing these therapeutics when compared to traditional molecules can also prove too much for some manufacturers, especially in the contemporary climate of reduced R&D spending.

Protein and Peptide-based Therapeutics - Trends in Drug Discovery and Development

This report provides an overview of the targeted indications of current molecules across 22 therapeutic areas, relevant technological developments, the manufacturing processes and the current regulatory environment

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts.

Abstract

Protein and Peptide-based Therapeutics - Trends in Drug Discovery and Development

Summary

GBI Research, leading business intelligence provider, has released its latest research report, entitled "Protein and Peptide-based Therapeutics - Trends in Drug Discovery and Development". Over the last decade, protein and peptide-based therapeutics have attracted more and more attention in the pharmaceutical industry. These types of molecules exert a high level of specificity on their respective molecular targets, making them highly advantageous and allowing them to be exploited therapeutically.

This report provides an overview of the targeted indications of current molecules across 22 therapeutic areas, relevant technological developments, the manufacturing processes and the current regulatory environment. In addition, an extensive analysis of the developmental pipeline for all protein and peptide-based therapeutics, excluding antibodies, across 11 therapeutic areas by phase, therapeutic area, route of administration, as well as mechanism of action and cell type/functional target is provided.

GBI Research has identified a sizable developmental pipeline for protein and peptide-based molecules in the therapeutic areas primarily targeted by these types of molecules, such as Central Nervous System (CNS), cardiovascular, immunology, musculoskeletal diseases, ophthalmology, infectious diseases, dermatology as well as metabolic, hematological, genetic, hormonal and gastrointestinal disorders. Overall, across these therapeutic areas, there are 571 molecules in the discovery, preclinical and clinical stages of development. These compounds have been identified in 953 indication-specific developmental programs, and 629 developmental programs are currently in clinical developmental.

The report also provides an overview of the top 15 licensing deals involving protein and peptide-based molecules since 2005, which are worth $6.9 billion and reflect a growing interest in licensing promising peptide and protein-based therapeutic molecules. They involve a number of major pharmaceutical companies, such as Pfizer, Sanofi, Merck & Co, Bristol-Myers Squibb and Merck Serono.

Scope

  • Technological trends in R&D of protein and peptide-based therapeutics include compound screening technology, drug delivery, bioavailability and degradation as well as rational drug design capacities.
  • An overview of the manufacturing options for protein and peptide-based therapeutics.
  • An overview of the regulatory environment for protein and peptide-based therapeutics including considerations around patent protection and exclusivity standards.
  • A detailed analysis of the developmental pipeline across 11 therapeutic areas including CNS, cardiovascular, immunology, musculoskeletal diseases, ophthalmology, infectious diseases, dermatology as well as metabolic, hematological, genetic, hormonal and gastrointestinal disorders. Stages of development, distribution across therapeutic areas, cell type and functional targets, mechanisms of action, and lastly, route of administration are analyzed.
  • The top 15 licensing agreements for protein and peptide-based therapeutics since 2005.

Reasons to buy

  • Identify key trends in the developmental pipeline for protein and peptide-based therapeutics across the 11 most frequently targeted therapeutic areas by these types of molecules.
  • Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules or identify gaps in the current developmental pipeline.
  • Exploit in-licensing and out-licensing opportunities by identifying products that might fill their portfolio gaps.
  • Identify the key strengths and weaknesses of protein and peptide-based therapeutics compared to small molecule drugs.
  • Identify key technological trends in the development and manufacture of protein and peptide-based therapeutics

TOC

1 Table of Contents

1 Table of Contents 5

  • 1.1 List of Tables 6
  • 1.2 List of Figures 6

2 Protein and Peptide-based Therapeutics - Introduction 7

3 Protein and Peptide-based Therapeutics - Market Overview 8

  • 3.1 Introduction to the Physiological Relevance of Proteins and Peptides 8
  • 3.2 The Organization and Structure of Proteins and Peptides 8
  • 3.3 The Application of Protein and Peptide-based Molecules for Therapeutic Purposes 9
  • 3.4 Benefits and Disadvantages of Protein and Peptide-based Therapeutics 18

4 Review of the Discovery and Development Process of Protein and Peptide-based Therapeutic Molecules 19

  • 4.1 Overview of the Discovery Phase 19
  • 4.2 Compound Screening Technology 21
    • 4.2.1 Phage-display Peptide Library Screening 21
  • 4.3 Drug Delivery, Bioavailability and Degradation 21
    • 4.3.1 Primary Challenges for Drug Delivery, Bioavailability and Degradation 21
    • 4.3.2 Strategies for Improved Bioavailability and Stability of Protein and Peptide-based Therapeutics 22
  • 4.4 Modifications of Protein and Peptide-based Therapeutics 24
    • 4.4.1 Glycosylation, Phosphorylation and Proteolytic Cleavage 24
  • 4.5 Rational Drug Design 25
    • 4.5.1 Bioinformatic and Structural Computational Approach to Drug Design 25

5 Summary of the Manufacturing Processes of Protein and Peptide-based Therapeutics 26

  • 5.1 Recombinant Cell Line Production of Protein and Peptide-based Therapeutics 26
  • 5.2 Peptide Synthesis 27

6 Regulatory Environment for Protein and Peptide-based Therapeutics 28

  • 6.1 Patent Protection 28
  • 6.2 Exclusivity for Biological Products 28

7 Pipeline Analysis of Protein and Peptide-based Therapeutics 30

  • 7.1 Overview of the Distribution of Protein and Peptide-based Therapeutics across Developmental Stages 30
  • 7.2 Pipeline Molecules per Therapeutic Area 31
  • 7.3 Overview of Targeted Cell Types, Functions and Mechanisms of Action of the Pipeline Molecules 32
  • 7.4 Route of Administration of Pipeline Molecule Developments 35

8 Licensing Deals for Protein and Peptide-based Therapeutics 36

  • 8.1 Bristol-Myers Squibb Enters into a Licensing Agreement with ZymoGenetics for Pegylated Interferon λ 37
  • 8.2 Hanwha Chemical Enters into Licensing Agreement with Merck for HD203 37
  • 8.3 Sanofi Enters into Licensing Agreement with Oxford BioMedica for TroVax 38
  • 8.4 Cephalon Enters into Licensing Agreement with ImmuPharma for Lupuzor 38
  • 8.5 BioMS Medical Enters into Licensing Agreement with Eli Lilly for MBP8298 38
  • 8.6 Human Genome Sciences Enters into Licensing Agreement with FivePrime Therapeutics for FP-1039 38
  • 8.7 Novacea Enters into Licensing Agreement with Schering-Plough for Asentar 39
  • 8.8 Celldex Therapeutics Enters into Licensing and Development Agreement with Pfizer 39
  • 8.9 Allergan Enters into Licensing Agreement with Molecular Partners for MP0112 39
  • 8.10 Onyx Pharma Enters into Licensing Agreement with Ono Pharma for Carfilzomib and ONX 0912 40
  • 8.11 Forest Labs Enters into Licensing Agreement with Microbia 40
  • 8.12 NPS Pharma Enters into Licensing Agreement with Nycomed for Gattex 40
  • 8.13 Pfizer Enters into Licensing Agreement with Scil Technology 40
  • 8.14 Cubist Pharma Enters into Licensing Agreement with Dyax 41
  • 8.15 Merck Serono Enters into Licensing Agreement with Apitope Technology 41

9 Protein and Peptide-based Therapeutics - Appendix 42

  • 9.1 Abbreviations 42
  • 9.2 Sources 42
    • 9.2.1 Research Methodology 43
    • 9.2.2 Coverage 43
    • 9.2.3 Secondary Research 43
    • 9.2.4 Primary Research 43
    • 9.2.5 Pipeline Analysis 44
    • 9.2.6 Expert Panel Validation 44
  • 9.3 Contact Us 44
  • 9.4 Disclaimer 44

List of Tables

1.1 List of Tables

  • Table 1: Protein and Peptide-based Therapeutics, Overview of Marketed Products in Therapeutic Areas and Indications 10

List of Figures

1.2 List of Figures

  • Figure 1: Protein and Peptide-based Therapeutics, Developmental Process and Applied Methods and Protocols 20
  • Figure 2: Protein and Peptide-based Therapeutics, Number of Clinical Trials by Stage of Development 30
  • Figure 3: Protein and Peptide-based Therapeutics, Developmental Pipeline of Lead Compounds by Therapeutic Area 31
  • Figure 4: Protein and Peptide-based Therapeutics, Developmental Pipeline by Targeted Cell Type, Cellular Function and Mechanism of Action 34
  • Figure 5: Protein and Peptide-based Therapeutics, Developmental Pipeline by Route of Administration 35
  • Figure 6: Protein and Peptide-based Therapeutics, Licensing Deals by Year, 2007-2011 36
  • Figure 7: Protein and Peptide-based Therapeutics, Overview of Major Licensing Deals by Value, 2007-2011 37
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