In the nearly 35 years since the first process for creating mAbs was introduced, they have remained a centerpiece of the growing biotechnology industry. Thirty therapeutic mAbs have been approved around the world, including 23 in the United States. A number of these drugs have attained blockbuster status, with sales reaching the coveted billion-dollar mark and well beyond. Rituxan, Remicade, Avastin, Herceptin, and Humira alone generated sales of over $4 billion each in 2008, and global sales for this entire sector surpassed $30 billion last year.

Key challenges and implications presented in this new report include:
  • Future products and their indications
  • Merits of human versus chimeric structures
  • Costs of mAb therapy and the US healthcare debate
  • Clinical pipeline with over 250 candidates
  • A focus on "engineered" antibodies


Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment reviews the broad drug development effort that is focused on bringing improved mAb-based products to the market, concentrating on those used for therapeutic applications. It surveys the latest technologies being applied to the development of these compounds and profiles the major companies, drugs, and projects. It then draws conclusions about the future market potential for mAbs and discusses the major challenges faced by the industry.

The biotech industry devoted years to reducing the immunogenicity of mAbs, developing the technologies—detailed in this report—to progress from chimeric, to humanized, to fully human antibodies. These succeeding generations of mAbs have demonstrated incremental improvements in safety and activity, and the industry is currently in the middle of a major shift toward humanized and human products.

Much work has also been done on altering antibodies’ outward form to boost their efficacy, enabling them to more readily penetrate tumors, enhancing their ability to stimulate beneficial immune responses, or otherwise improving their characteristics. Into this realm fall such constructions as antibody fragments, diabodies, synthetic antibodies, bispecific antibodies, and antibody conjugates. This report looks at some of the engineered forms of antibodies and the companies that are leading the way in this research. Other complementary technologies, such as PEGylation and glycosylation, are also presented.

Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment presents an analysis for the current state of mAb drug development. It identifies more than 250 therapeutic products now in clinical trials, which are largely concentrated in the areas of cancer, immunological and inflammatory diseases, as well as infectious diseases. Beyond these, hundreds more candidates are at the preclinical stage of development. Reviewed here are the products that are already available, those in clinical development, and those still at the preclinical stage that are likely to play an important role in the advancement of the field.

Please note, this report is delivered as a zip file.  
 

Table Of Contents

Executive Summary
Chapter 1
BACKGROUND AND SCIENTIFIC OVERVIEW:
ANTIBODIES AND MONOCLONAL ANTIBODIES
1.1. What Is an Antibody?
1.2. What Is a Monoclonal Antibody?
Chapter 2
CURRENT AND EMERGING TECHNOLOGIES:
IMPROVING MONOCLONAL ANTIBODY
DESIGN AND PRODUCTION
2.1. Key Breakthroughs in the First 35 Years of Monoclonal Antibody
Development
Murine-Derived Monoclonal Antibodies
Chimeric Monoclonal Antibodies
Humanized Monoclonal Antibodies
Fully Human Monoclonal Antibodies
Antibody Fragments
Antibody Conjugates
2.2. Monoclonal Antibody Libraries and Display Technologies
Phage Display
MedImmune (AstraZeneca)
Dyax
Crucell
MorphoSys
Affitech
Biosite (Inverness Medical Innovations)
Affimed Therapeutics
XOMA
Ribosome Display
MedImmune (AstraZeneca)
Discerna
Other Library-Based Technologies
Alexion Pharmaceuticals
BioInvent International
viii and#149; www.InsightPharmaReports.com and#149; Reproduction prohibited
Table of Contents
Adimab
MSM Protein Technologies
Vaccinex
Morphotek (Eisai Corp. of North America)
AnaptysBio
Sorrento Therapeutics
2.3. Other Technologies for Designing Monoclonal Antibodies
Techniques for Improving Hybridoma Production
Abeome
New Techniques for Generating Animal-Derived Monoclonal
Antibodies
GENOVAC (Aldevron)
Epitomics
North Coast Biologics
Xori
Chiome Bioscience
Humanization Technology
Abmaxis (Merck)
Arana Therapeutics
MRC Technology
ImmunoGen
KaloBios Pharmaceuticals
PDL BioPharma
XOMA
Antitope
Xencor
Massachusetts Institute of Technology
Transgenic Mice
Amgen
Medarex
AVANIR Pharmaceuticals
Regeneron Pharmaceuticals
Human Hybridoma Technology
Morphotek (Eisai Corp. of North America)
Patrys
Kenta Biotech
2.4. Alternative Antibody Formats
Antibody Fragments
ESBATech
MacroGenics
Genmab
Synthetic Antibodies
Ablynx
Affibody
Domantis (GlaxoSmithKline)
AdAlta
Enzon Pharmaceuticals/Micromet
Arana Therapeutics
Bispecific Antibodies
Elusys Therapeutics
Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment
Micromet
TRION Pharma
Affimed Therapeutics
Affitech/Pharmexa
Biotecnol
Other Antibodies That Enhance Effector Function
BioWa
MacroGenics
Tolerx
Vaccibody
InNexus Biotechnology
Xencor
2.5. Antibody Conjugates
Antibody-Radioisotope Conjugates
Affibody
PBL Therapeutics
Aduro BioTech
Antibody-Drug Conjugates
Medarex
HERMES Biosciences
Celldex Therapeutics
Scancell
Paladin Labs
Antibody-Toxin Conjugates
2.6. Technologies for Improving Monoclonal Antibody
Characteristics
Protein Engineering
Applied Molecular Evolution (Eli Lilly)
Arana Therapeutics
Morphotek
MilleGen/Accuro Biologics
Facet Biotech
Xencor
Merus
Algonomics
f-star
PEGylation
Alternatives to PEGylation
Glycosylation
GlycArt (Roche)
GlycoFi (Merck)
Glycotope
Synageva BioPharma
LFB
Alternative Modes of Administration
Altus Pharmaceuticals
Baxter BioPharma Solutions
Chapter 3
MARKETED AND EMERGING MONOCLONAL
ANTIBODIES: PRESENT AND FUTURE
THERAPEUTICS
3.1. Approved Therapeutic Monoclonal Antibodies
Profiles of Therapeutic Monoclonal Antibodies Approved for
Marketing
Orthoclone OKT3 (Muromonab-CD3) (1986)
ReoPro (Abciximab) (1994)
Rituxan (Rituximab) (1997)
Zenapax (Daclizumab) (1997)
Simulect (Basiliximab) (1998)
Synagis (Palivizumab) (1998)
Remicade (Infliximab) (1998)
Herceptin (Trastuzumab) (1998)
Mylotarg (Gemtuzumab Ozogamicin) (2000)
Campath (Alemtuzumab) (2001)
Zevalin (Ibritumomab Tiuxetan) (2002)
Humira (Adalimumab) (2002)
Xolair (Omalizumab) (2003)
Bexxar (Tositumomab) (2003)
Raptiva (Efalizumab) (2003)
Erbitux (Cetuximab) (2004)
Avastin (Bevacizumab) (2004)
Tysabri (Natalizumab) (2006)
Lucentis (Ranibizumab) (2006)
Vectibix (Panitumumab) (2006)
Soliris (Eculizumab) (2007)
Cimzia (Certolizumab Pegol) (2008)
Ilaris (Canakinumab) (2009)
3.2. Monoclonal Antibodies in Development for Cancer
Unconjugated Monoclonal Antibodies for Cancer
Genmab
Medarex
Biogen Idec
Genentech
Human Genome Sciences
Pfizer
Wilex
Immunomedics
ImClone Systems (Eli Lilly)
Morphotek (Eisai Corp. of North America)
Antisoma
Micromet
UCB
AVEO Pharmaceuticals
Lpath
Northwest Biotherapeutics
Anti-idiotype Monoclonal Antibodies for Cancer
Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment
Menarini Group
Onyvax
Conjugated Monoclonal Antibodies for Cancer
Active Biotech
Antisoma
ImmunoGen
Immunomedics
MedImmune
Seattle Genetics
Merck Serono
Celldex Therapeutics/Curagen
3.3. Monoclonal Antibodies in Development for Immunological
Diseases
Human Genome Sciences
Novartis
UCB
Amgen
Biogen Idec/Genentech
MedImmune
Genmab
Millennium Pharmaceuticals (Takeda Pharmaceutical)
Medarex
NovImmune
BioTie Therapies
Micromet
ZymoGenetics/Novo Nordisk
Glenmark Pharmaceuticals
CSL
LigoCyte Pharmaceuticals
Sanofi-Aventis/Kyowa Hakko Kirin
3.4. Monoclonal Antibodies in Development for Infectious Diseases
Novartis
MedImmune
Human Genome Sciences
Taimed Biologics
Medarex
Elusys Therapeutics
Emergent BioSolutions
Crucell
Progenics Pharmaceuticals
Roche
Genmab
Theraclone Sciences
iBioPharma
3.5. Monoclonal Antibodies in Development for Cardiovascular
Diseases
Ablynx
ThromboGenics/BioInvent International
Affimed Therapeutics
Table of Contents
Lexicon Pharmaceuticals
3.6. Other Therapeutic Antibodies in Development
Amgen
Elan/Wyeth
Eli Lilly
Pfizer
Others
Chapter 4
BUSINESS AND STRATEGIC OUTLOOK: MARKET
POTENTIAL FOR MONOCLONAL ANTIBODIES AND
TRENDS IN THE FIELD
4.1. General Trends
4.2. The Market for Therapeutic Monoclonal Antibodies
Cancer: Solid Tumors
Cancer: Non-Hodgkinandrsquo;s Lymphoma
Immune and Inflammatory Diseases
Transplant Rejection
Rheumatoid Arthritis
Crohnandrsquo;s Disease
Psoriasis
Lupus
Multiple Sclerosis
Asthma
Other Emerging Markets
Age-Related Macular Degeneration
HIV
Alzheimerandrsquo;s Disease
Chapter 5
CHI INSIGHT PHARMA REPORTS MONOCLONAL
ANTIBODIES SURVEYandmdash;JULY 2009
References
Company Index with Web Addreses
Monoclonal Antibodies: Pipeline Analysis and Competitive Assessment
Tables
Table 3.1. FDA-Approved Therapeutic Monoclonal Antibodies
Table 3.2. Unconjugated Monoclonal Antibodies in Clinical Trials for Cancer
Table 3.3. Conjugated Monoclonal Antibodies in Clinical Trials for Cancer
Table 3.4. Monoclonal Antibodies in Clinical Trials for Immunological Diseases
Table 3.5. Monoclonal Antibodies in Clinical Trials for Infectious Diseases
Table 3.6. Monoclonal Antibodies in Clinical Trials for Cardiovascular Diseases
Table 3.7. Other Therapeutic Monoclonal Antibodies in Clinical Development
Table 4.1. Worldwide Sales of Therapeutic Monoclonal Antibodies,2007 and 2008
Table 4.2. Estimated New Cancer Cases in United States, Total and Selected Types, 2009
Figures
Figure 1.1. Structure of an Antibody
Figure 2.1. Monoclonal Antibody Production
Figure 2.2. Antibody Engineering
Figure 2.3. Engineered Forms of Antibodies
Figure 1A. Please classify your organization
Figure 2A. Focus of Respondentsandrsquo; Organizations
Figure 3A. Professional Responsibilities of Respondents
Figure 4A. Changes in mAb Pipelines
Figure 5A. Magnitude of Increase in mAb Pipelines
Figure 6A. Recent Changes in Level of Activity Related to mAbs
Figure 7A. Future Changes in Level of Activity Related to mAbs
Figure 8A. Rate of New mAb Approvals
Figure 9A. Challenges to mAb Development
Figure 10A. Key Technologies
Figure 11A. Future Improvements to mAbs
Figure 12A. Relevant Disease Areas

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