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Directed Molecular Evolution

Product lifecycle management for biologics

Publication Date   May 2006
Publisher   Datamonitor
Product Type   Strategic Report
Pages   136
ISBN Number   not applicable
Product Code   DAT477
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Price £4,000.00

approximately: $8,026 | €5,021

Summary


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. DMEa method for optimizing biologicsdirectly 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

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

Content


  • 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