Directed Molecular Evolution: Product Lifecycle Management For Biologics

Published by: Datamonitor

Published: May. 4, 2006 - 136 Pages

Table of Contents

CHAPTER 1 EXECUTIVE SUMMARY

Key Findings

Scope

Definition of key terms

Small molecules

Biologics

Monoclonal antibodies

Therapeutic proteins

Biologics market size

Biologics market growth rate

Threat to biologics - bio-similars

DME science

DME companies

Applied Molecular Evolution

Maxygen

Cambridge Antibody Technology (CAT)

MorphoSys

The first DME to hit the market - Synagis/Numax

DME-based business models

CHAPTER 2 THE COMMERCIAL CONTEXT FOR DME - THE BIOLOGICS MARKET

Introduction

Definition of key terms

Small molecules

Biologics

Monoclonal antibodies

Therapeutic proteins

Biologics market size

Biologics market growth rate

Threat to biologics - bio-similars

Wave of patent expiries makes biogenerics a priority

High cost of biologics increases the importance of biogenerics

Proving equivalence of the protein

Threat to biologics from intensifying competition

Current techniques for optimizing biologics

Current techniques for optimizing for protein therapeutics

Current techniques for optimizing mAbs

Chimeric antibodies

CDR grafting

DME - a technology for the ‘evolutionary’ optimization of biologics

CHAPTER 3 THE SCIENCE OF DIRECTED MOLECULAR EVOLUTION

Key findings

Concept of DME - diversification and selection

Application - lead optimization for biologics

Diversification technologies

Selection technologies

Cell screening

Protein formats

The DME technology landscape

Amgen and Genentech - Participating in DME?

DME intellectual property

CHAPTER 4 APPLIED MOLECULAR EVOLUTION

Key findings

Company history

Eli Lilly acquisition

DME: providing Lilly the opportunity of accessing new markets

AME technology

AME’s technology: the AMEsystem

DirectAME frAMEworks

ExpressAME

SelectAME

AME’s financial position

AME’s R&D collaborations

Bristol Myers-Squibb first to test AME

MedImmune set to benefit from AME

Other collaborations

AME’s internal R&D

AME-527

AME-133

AME-359

CHAPTER 5 MAXYGEN

Key findings

Maxygen company history

Maxygen technology

Maxygen’s technology: Molecular Breeding

Maxygen’s financial position

Maxygen’s R&D collaborations

Maxygen achieved industry connections and reputation through process design collaborations

Roche is Maxygen’s biggest collaborative partner

Maxy-Alpha (HCV)

Maxy-Factor VII

Other collaborations

Maxygen’s internal R&D

MAXY-G34/G-CSF

Maxygen has a strong vaccine initiative

Summary

CHAPTER 6 OTHER DME PLAYERS

Introduction

Cambridge Antibody Technology (CAT)

Phage display technology

Ribosome display technology

Partnerships

Product portfolio and pipeline

Summary

MorphoSys

MorphoSys technology

MorphoSys proprietary candidates

MorphoSys collabroative agreements

Summary

Dyax

Summary

Crucell

Summary

Diversa

Genencor

Direvo AG

MilleGen

CHAPTER 7 CASE STUDY: SYNAGIS/NUMAX - THE FIRST DME PRODUCT TO REACH THE MARKET?

Introduction

The facts about RSV

CHAPTER 8 APPENDIX

References

LIST OF TABLES

Table 1: General characteristics of small molecule drugs vs. biologics

Table 2: AME’s financial performance

Table 3: AME’s proprietary candidates

Table 4: Leading treatments in AIID

Table 5: Maxygen’s financial performance

Table 6: Maxygen’s proprietary candidates

Table 7: Revenue outlook for Neulasta and Neupogen

Table 8: Products developed using CAT’s phage display technology

Table 9: Summary of MorphoSys collaborations, 2000-06

Table 10: Synagis historical sales and forecasts, 2003-10

Table 11: Forecast global sales of Numax ($m), 2006-10

LIST OF FIGURES

Figure 1: Global sales by molecule class ($bn), 2001-10

Figure 2: Percentage contribution to global sales, 2005 and 2010 split by molecule class

Figure 3: CAGR trends split by product class

Figure 4: DME can be viewed as lead optimization for biologics

Figure 5: The DME concept: diversification then selection

Figure 6: Diversification technologies used in DME

Figure 7: Selection technologies used in DME

Figure 8: Synagis vs. Numax - schematic diagram of amino acid differences

Figure 9: Global sales by 2001-2010 split by molecule class

Figure 10: Percentage contribution to global sales, 2005 and 2010 split by molecule class

Figure 11: CAGR trends split by product class

Figure 12: The DME concept - diversification then selection

Figure 13: Successive diversify-select cycles drive optimization

Figure 14: DME is analogous to natural evolution

Figure 15: DME can be viewed as lead optimization for biologics

Figure 16: Diversification technologies used in DME

Figure 17: An overview of DNA shuffling/molecular breeding

Figure 18: Selection technologies used in DME

Figure 19: The range of candidate protein types eligible for DME

Figure 20: The DME technology landscape

Figure 21: The DME technology landscape

Figure 22: The AMEsystem

Figure 23: mAb optimization

Figure 24: AME collaborative timeline

Figure 25: AME’s collaboration network map

Figure 26: Tg197 transgenic murine model of rheumatoid arthritis

Figure 27: AME-133 model results

Figure 28: Maxygen/Codexis’s collaboration: process design

Figure 29: Maxygen’s collaborations: biologic therapeutics

Figure 30: CAT’s partnerships for its phage display technology

Figure 31: Diversa

Figure 32: Genencor

Figure 33: Direvo

Figure 34: MilleGen

Figure 35: Synagis vs. Numax - schematic diagram of amino acid differences

Figure 36: The Synagis-Numax switch

Abstract

• Assessment of the DME total market opportunity using global sales forecasts for all biologics, split by company and therapy area, spanning 200110
• Classification system for understanding DME technologies decomposing the process into diversification, selection and protein format steps
• Detailed company analysis of both AME and Maxygen in terms of corporate history, internal pipeline, alliance networks and financial performance
• Analysis of how companies such as MorphoSys and CAT are using 'display systems' to accelerate the DME process in drug discovery

• Learn how DME opens up a route to generating highly optimized versions of currently marketed biologics and vaccines
• Understand how DME can be applied in the discovery and development process to enhance the binding affinity and stability of biologic lead candidates
• Identify the key holders of DME technology, how to gain access to this powerful method and which techniques are best suited to which biomolecule types

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