Antibody Therapeutics: Product Development, Market Trends, and Strategic Issues (Revised Edition) : Market Research Report

Antibody Therapeutics: Product Development, Market Trends, and Strategic Issues (Revised Edition)

Published by: Drug and Market Development Publishing

Published: Oct. 1, 2006 - 415 Pages

Chapter 1: Executive Summary: Key Points 2004-2006
Chapter 2: Introduction, Scope, and Objectives: Early Status and Current Products; Driving Forces; Customers; Competition; Scope and Objective
Chapter 3: Hybridoma Technology and Antibody Gene Manipulation: Introduction; Historical Roots; Classical Antibody Development; Hybridoma Technology; Genetic Immunization; Molecular Biology Applied To Antibody Characterization; References
Chapter 4: Status of Therapeutic Antibody Products: Introduction; Therapeutic Anticancer Antibodies; Immunoconjugated Anticancer Recombinant Antibodies; Cardiovascular Disorders; Infectious Diseases; Inflammatory Diseases; Transplantation; References
Chapter 5: Clinical Studies: Approved Antibody Therapeutics; Therapeutic Antibodies in Development; Failed Antibody Therapeutics; Catastrophic Clinical Trial; Status of A Few Selected Ongoing Clinical Studies
Chapter 6: Large Scale Manufacturing: Overview; Companies Involved; Risks of Innovation in Biomanufacturing; Bioprocessing Technologies; Production Systems; Antibody Glycosylation Issues; New Purification Tools; Monitoring Technologies; Is There a Shortage in Manufacturing Capability?; Insulin: A Case History of Recombinant Protein Production; The Future; References
Chapter 7: Business Development and Partnering: Collaboration and Partnering; Mergers and Acquisitions
Chapter 8: Patents and Intellectual Property Issues: Introduction; Intellectual Property Issues; Antibody Humanization; Human Antibody Technology; Antibody Production; Litigations and Co-licensing; Court Rulings about Importing Data; More Litigations; Xoma vs..Biosite; The Single-Chain Antibody Technology; Recent IP Issuance and Related Activities; Abstracts of the Selected Patents Mentioned in the Text
Chapter 9: Market Status: Revenues from the Early Products; Revenues from the Recently Approved Products; New Product Approvals
Chapter 10: Company Profiles
TABLE OF EXHIBITS: Exhibit 2.1. Selection of Phage Antibodies from an Antibody Library; Exhibit 2.2. Mechanisms of Actions In Vivo of Therapeutic Antibodies; Exhibit 2.3. List of Companies Involved in the Discovery and Development of Antibody. Therapeutics; Exhibit 2.4. List of Therapeutic Monoclonal Antibodies Approved for Additional Indications, September 2006; Exhibit 2.5. Primary Technology Portfolio of a.Selected Group of Antibody Companies; Exhibit 3.1. Major Events in the History of Immunology Compiled from Various Sources; Exhibit 3.2. Basic Structure of an IgG Molecule; Exhibit 3.3. A Space-filling Model of an IgG Molecule; Exhibit 3.4. The GENOVAC Technology for the Production of Polyclonal..(Steps 1-4)and. Monoclonal Antibodies.(Steps 1-7); Exhibit 3.5. Choices when Constructing a.Binding-site Library; Exhibit 3.6. Scheme Showing the Principle of Selection and Improvement of Binding Sites; Exhibit 3.7. Schematic Diagram of Ribosomal Display; Exhibit 3.8. Comparison of Structural Features of Human Antibody, Camelid Antibody, and Nanobodies; Exhibit 3.9. Schematic Diagram Showing Structural Features of Single Chain Antibody.(scFv).and Fab Fragment; Exhibit 3.10 Various Forms of Bispecific Antibodies; Exhibit 3.11 Various Types of Antibodies; Exhibit 3.12 Schematic Diagram of the Generation of Human Antibody Mouse; Exhibit 4.1. Various Mechanisms of Antibody Actions; Exhibit 4.2. Approved Monoclonal Antibodies for the Treatment of Various Cancers; Exhibit 4.3. Schematic Diagram Showing the Mechanism of ADCC; Exhibit 4.4. Schematic Diagram Showing the Structural Feature of Epidermal Growth Factor Receptor and the Binding to its Ligand.(egf); Exhibit 4.5. EGFR Expression in Various Tumors; Exhibit 4.6. Approved Antibody Therapeutic for the treatment of Cardiovascular Disorders; Exhibit 4.7. Summary of Antibody Studies in the Prevention and Treatment of Infectious Diseases; Exhibit 4.8. Approved Antibody for the Treatment of Infectious Disease; Exhibit 4.9. Approved MAbs for the Treatment of Inflammatory Diseases; Exhibit 4.10. Inflammation in the Rheumatoid Joint; Exhibit 4.11 Mode of Action of Xolair™; Exhibit 4.12 Market for Drugs to Treat Asthma in US.$.Million; Exhibit 4.13 Approved MAb for the Treatment of Transplantation; Exhibit 5.1. List of Approved Therapeutic Monoclonal Antibodies for Major Markets, September 2006; Exhibit 5.2. List of Therapeutic Monoclonal Antibodies Approved for Additional Indications, September 2006; Exhibit 5.3. Therapeutic Categories of Approved MAbs; Exhibit 5.4. Types of MAbs Approved Between 1986 and 2006; Exhibit 5.5. Types of MAbs Currently in Development; Exhibit 5.6. List of Monoclonal Antibody Therapeutics in Development (assembled by alphabetized company names); Exhibit 5.7. List of Monoclonal Antibody Therapeutics in Development (assembled by therapeutic indication in alphabetical order); Exhibit 5.8. Therapeutic Categories of Clinical Trials; Exhibit 5.9. Therapeutic Antibodies at Various Development Stages; Exhibit 5.10 List of Late-Stage Clinical Trial Failures; Exhibit 6.1. Distribution of Cell Culture Reactor Capability by Reactor Volume, Projected for 2006; Exhibit 6.2. Selected North American Contract Manufacturer, Primarily of Biotherapeutics; Exhibit 6.3. Selected Contract Manufacturers Outside of North America; Exhibit 6.4. Selected Manufacturers Offering Excess Capacity Contracts; Exhibit 6.5. Native and Engineered Disulfide Bond formation Pathways in the E. coli Periplasm; Exhibit 6.6. A comparison of Widely Used Cell Lines for the Manufacturing of Biotherapeutics; Exhibit 6.7. Processing of Asn-linked Oligosaccharides to a.Representative Biantennary Complex Glycoprotein Structure; Exhibit 7.1. Selected Companies with Antibody Discovery Platforms Which Formed Alliances in the Discovery and Development of Antibody Therapeutics; Exhibit 7.2. Selected Companies with Antibody Engineering and Expression Platforms Which Formed Alliances; Exhibit 7.3. Valuation of Collaborations; Exhibit 7.4. .Selected M&As In 2005 And Early 2006; Exhibit 7.5. Detailed List of Alliances Involving a.Selected Number of Antibody Drug Discovery and Development Companies; Exhibit 8.1 Issued Patents of Xencor; Exhibit 8.2. Patent Applications of Xencor; Exhibit 8.3 Additional Patent Applications Related to Enhanced Antibody Function; Exhibit 8.4. Issued Patents of Kyowa Hakko and BioWa; Exhibit 8.5. Patent Applications of Kyowa Hakko and BioWa; Exhibit 8.6. Flow-chart Showing Various Technologies Important for MAb Discovery, Modulation and Production and the Primary IP Holders of the Technologies; Exhibit 8.7. Key Antibody Phage Display patents of Cambridge Antibody Technology; Exhibit 8.8. Single-chain Antibody IP Portfolio of Micromet/Enzon; Exhibit 8.9. A Selected List of Relevant US Patents; Exhibit 9.1. Yearly Fundraising by the Biotechnology Industry; Exhibit 9.2. Status of Market Capitalization of a.Selected Group of Antibody Companies; Exhibit 9.3. Major Monoclonal Antibody Sales, 2003-2005.; Exhibit 9.4. Yearly Revenues Earned and Forecasted for Antibody Therapeutics; Exhibit 9.5. .Annual Sale of Rituxan®.in.$.million, 2001.-.2005; Exhibit 9.6. Annual Sale of Herceptin®.in.$.million, 2000.-.2003; Exhibit 9.7. Revenues Generated by Remicade®, 2000.-.2005; Exhibit 9.8. Revenues Generated by Synagis®, 2000.-.2005; Exhibit 9.9. Quarterly Sales of Synagis®.from 2001 to 2005; Exhibit 9.10 Comparative Sales of Humira™.and Avastin™, 2003 to 2005; Exhibit 9.11 Current and Projected Sales of Avastin™

Abstract

D&MD’s Antibody Therapeutics market analysis report provides an update of the current market environment including clinical study status, progresses made in the area of collaborations and partnerships, patent situation, and finally the market status. These developments are primarily in the antibody market place and in clinical development areas as opposed to in the antibody discovery field as was observed in the early part of this decade.

About the Author

Rathin C. Das, Ph.D., M.B.A. is the Chief Business Officer of the human antibody therapeutics company, Affitech AS of Oslo, Norway and President of its US subsidiary, Affitech USA, Inc. of Walnut Creek, CA. He has over 22 years of experience in the bio/pharmaceutical industry in research and development, technology and product licensing, business development and corporate management. Dr. Das is also the Editor of the biotechnology trade journal, the American Biotechnology Laboratory, and has published numerous articles and publications including D&MD’s Antibody Therapeutics, Antibody Engineering and Display Technologies.

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Antibody Therapeutics: Product Development, Market Trends, and Strategic Issues (Revised Edition)

Table of Contents

Abstract