Expert Intelligence for Better Decisions The New Generation of Antibody Therapeutics: Current Status and Future Prospects K. John Morrow, Jr., PhD Using This Document A navigation bar containing links to the Table of Contents, a Search feature, Insight Pharma Reports are interactive Previous/Next page arrows, and a Return button is anchored at the bottom of electronic documents which offer many each page. of the features of Web sites, including Hyperlinks throughout the document are designated by blue, underlined text. navigation, search, bookmarks, download Hyperlinks on the Index page are also rendered as blue text, and will navigate you options, and additional layered content. to a company’s Web site. Table of Contents listings are hyperlinked and will navigate you directly to that specific content, Table or Figure. Reports are also available Figures and Tables found within the document are available for download by clicking on a selected Figure or the title of a Table. 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Related Reports Fragment-Based Drug Discovery Engineering Next-Generation Therapeutic Technologies, Applications, and Pipelines Proteins by Peter Norman, MBA, PhD Trends and Markets To 2020 by Hermann AM Mucke, PhD Managing Director: Laurie Sullivan 781-972-1353, [email protected] Design Director: Thomas Norton 781-972-5440, [email protected] Production Director: Ann Marie Handy 781-972-5493, [email protected] Customer Service: Rose LaRaia 781-972-5444, [email protected] Corporate Subscriptions: David Cunningham 781-972-5472, [email protected] Insight Pharma Reports, 250 First Avenue, Suite 300, Needham, MA 02494 n www.InsightPharmaReports.com iv The New Generation of Antibody Therapeutics: Current Status and Future Prospects by K. John Morrow, Jr., PhD About the Author K. John Morrow, Jr., PhD, is a writer and consultant for the biotechnology industry. He obtained his PhD in genetics from the University of Washington in Seattle, and completed his training with post-doctoral studies in Italy at the Universitá di Pavia and in Philadelphia at the Fox Chase Cancer Institute. He has held faculty positions at the University of Kansas and at Texas Tech University Health Sciences Center. His writings include over 200 peer-reviewed journal papers, non–peer-reviewed coverage of the biotechnology industry, books, and marketing reports. A number of companies, including Meridian Bioscience, Affitech, Henderson- Morley Biotechnology, Brandwidth Communications, and Emergent Technologies have taken advantage of his consultancy services, provided through Newport Biotechnology Consultants. He resides in Newport, KY. For more information about published Insight Pharma Reports, visit www.InsightPharmaReports.com or call Rose LaRaia at 781-972-5444 A Cambridge Healthtech Institute publication © 2012 by Cambridge Healthtech Institute (CHI). This report cannot be duplicated without prior written permission from CHI. Every effort is made to ensure the accuracy of the information presented in Insight Pharma Reports. Much of this information comes from public sources or directly from company representatives. We do not assume any liability for the accuracy or completeness of this information or for the opinions presented. Cambridge Healthtech Institute, 250 First Avenue, Suite 300, Needham, MA 02494 Phone: 781-972-5444 n Fax: 781-972-5425 n www.InsightPharmaReports.com v Executive Summary The New Generation of Antibody Therapeutics: Current Status and Future Prospects Executive Summary ntibody therapeutics remains the shining star of the may require dosing for years. For small-molecule drugs, costs run from pharma industry, yet there is a constant push to explore pennies to as much as a dollar per day, yet biopharmaceuticals average new approaches as pipelines become glutted with “me-too” $22 per day. The top 6 biologic drugs take up 43% of the Medicare Part A products. Currently approved antibodies are expecting a B drug budget. And the situation can only get worse. The world’s 9 most growth from 22 billion euros ($32 billion) in 2008 to approximately 40 expensive drugs all run in the range $200,000 to $400,000 per annum, billion euros ($58 billion) by 2014. and with proper therapy, individuals with these conditions may enjoy Despite increasing R&D budgets, Big Pharma has been unable to decades of life. increase its yield of approved drugs per dollar of R&D expenditures. This Antibodies are a formidable and elegant technology, yet costly, report profiles many approaches underway to increase an abysmal record representing complex molecules that can bind to a wide range of of productivity. While these strategies may take effect in the long run, molecular sites. Thirty-one antibodies have been approved by the FDA they are unlikely to have immediate repercussions. for treatment of a range of disorders, including cancer and autoimmune Today’s biotech industry is fiercely competitive and can be a “winner dysfunction (and one for infectious disease). Whereas antibodies have takes all” environment. As the battle heats up, the climate encourages been demonstrated to extend length and quality of life in a number companies to overpromise. There are many new technologies that are of cases, they do not constitute a cure and they cannot be used alone, hyped as delivering new treatments in the next 5 years. These rosy but must be combined with conventional chemotherapy. They are predictions represent a disconnect with reality, as they don’t take into complicated to administer and extremely expensive. account the years and uncertainty of clinical trials that these compounds The difficulties encountered with potential therapeutic antibodies must go through. for Alzheimer’s disease are illustrative of the plight of the industry as The success of biologics, especially antibodies, has been accompanied a whole, and may explain why the introduction of new antibodies has by increasing concerns over their cost, and whether it is sustainable proceeded at such a sluggish pace. Despite the amazing progress in our in the long run. Not only do antibodies have a high unit cost, but they understanding of biological systems in the last 60 years, we still lack a are frequently employed in the treatment of chronic conditions and complete and thoroughgoing knowledge of the molecular