Abstract
Overview
Introduction
Biologics are forecast to be the fastest growing segment of the pharmaceutical
market out to 2010 (12.2% CAGR). However, biologics face the emergence of
bio-similars and increasing numbers of competitor products, both factors that
intensify the commercial need for next-generation biologics with superior
product characteristics. DME-a method for optimizing biologics-directly
addresses this need.
Scope
- Assessment of the DME total market opportunity using global sales
forecasts for all biologics, split by company and therapy area, spanning
2001-10
- 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
Report Highlights
Alliance network maps revealing which pharmaceutical players are accessing DME
through product technology collaborations with AME and Maxygen - including an
analysis of how Eli Lilly's 2004 acquisition of AME redefined the DME
competitive landscape.
Case study of how MedImmune applied DME to its marketed anti-RSV monoclonal
antibody Synagis to create the next-generation product Numax, which is
forecast to produce global sales in excess of $1bn by 2010.
Review of the major DME technologies which are in use with a consideration of
their relative strengths and weaknesses and suitability for different
commercial applications.
Reasons to Purchase
- 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
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
- Recent CHMP recommendation for Omnitrope a sign of things to come?
- 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
- 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
- Overview
- Market dynamics
- Methodology
- AME-133
- Overview
- Market dynamics
- Methodology
- 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
- Maxy-1100
- Maxy-1200
- Maxy-1500
- Maxy-201
- Maxy-829
- Maxy-14
- 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
- Crucell
- Diversa
- Genencor
- Direvo AG
- MilleGen
- CHAPTER 7 CASE STUDY: SYNAGIS/NUMAX - THE FIRST DME PRODUCT TO REACH THE
MARKET?
- Introduction
- The facts about RSV
- Synagis (palivizumab)
- The role of DME in RSV
- Numax (motavizumab)
- DME has provided MedImmune with a successful lifecycle management
strategy
- CHAPTER 8 APPENDIX
- References
- List of Tables
- Table 1: General characteristics of small molecule drugs vs. biologics
- 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
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