REPORT SCOPE
INTRODUCTION
In 1971, U.S. President Richard Nixon declared a “War on Cancer” and congress passed the National Cancer Act, committing the nation to putting an end to this collection of dread diseases. More than 30 years later, the incidence of cancer is about the same as it was in 1950 and chances of survival are not much better.
For decades, cancer therapy has been dominated by chemotherapy. Unfortunately, for most cancers, chemotherapy does not work very well, if at all. Diagnosis of pancreatic cancer or liver cancer, for example, essentially is a death warrant, and most cancers have poor prognosis unless they are found really early. The recent approvals of biopharmaceuticals like Avastin™, Erbitux™ and Herceptin™, all monoclonal antibody drugs, have given hope that the tide finally is turning.
Monoclonal antibodies are not the only tricks available in the biotechnology tool chest. It includes protein hormones and cytokines, antisense oligonucleotides, gene therapy, oncolytic viruses and cancer vaccines. Biopharmaceuticals approved so far for oncology indications are of three general types: monoclonal antibodies, colony stimulating factors and peptide hormone analogues. Other biopharmaceuticals, such as oligonucleotides, gene therapies, therapeutic vaccines, or oncolytic viruses have yet to be approved in major markets.
The promise of biotechnology finally is being brought to bear on this most problematic of diseases and its many manifestations. It appears, therefore, to be a propitious time to report on therapies being developed and assess the likelihood for success of these new therapies. This BCC report does just that, quantifying historical and projected sales for biopharmaceutical products to treat cancer.
SCOPE OF STUDY
The report:
- Identifies all major biopharmaceuticals that were in clinical trials to treat cancer as of the spring of 2004
- Describes these biopharmaceuticals and their proposed mechanisms of action
- Identifies and profiles companies involved in developing biopharmaceuticals
- Discusses regulatory policies that affect the development of biopharmaceuticals
- Estimates current markets for biopharmaceutical drugs and project future sales five years out, through 2008.
METHODOLOGY AND INFORMATION SOURCES
The information reported herein has been gathered from a variety of industry and other sources. The 10K forms and other SEC filings from public companies have been examined along with annual reports, catalogues, press releases et cetera. Clinical trial information on cancer drugs was retrieved from the OVID database. The World Wide Web is a rich source of information, as almost every commercial concern now has its own web page. Much statistical information was garnered from the American Cancer Society, the Federal government and the World Health Organization.
Armed with the industry and statistical information garnered above, market participants have been interviewed as necessary to fill in the gaps of our understanding.
ANALYST'S CREDENTIALS
The author of this report, Steven Edwards, Ph.D., has a broad background in the biological and health sciences and is well acquainted with advancing technology. He received his doctorate in Biology from the University of California, San Diego. His thesis work centered on the expression of murine leukemia virus genes and was then awarded a National Health Institutes postdoctoral Fellowship to study neuroendocrinology at Salk Institute. Subsequently, Dr. Edwards was a Research Associate at La Jolla Cancer Research Foundation (now Burnham Institute) and later an Assistant Professor in the Biochemistry Department of Meharry Medical College. There he directed a research laboratory studying transcriptional regulation supported by grants from the American Heart Association and the NIH.
Dr. Edwards is now a medical industry analyst and science writer and editor. He has been editor of several BCC newsletters: Applied Genetics News, and Drug Discovery/Technology News, Cell Therapy News and Nano/Bio Convergence News, and is now editor of Biomolecular Diagnostic News, also published by BCC. His journalistic work has also appeared in MIT's Technology Review, Diabetes Forecast, Genetic Engineering News, and other publications.
Dr. Edwards was the Project Analyst responsible for the BCC reports B-119 Cell Therapy and Tissue Engineering, Emerging Products (1998), B-127 Microelectronic Medical Implants, Products, Technology and Opportunity (1999), B-143 Bones and Joints: Drugs, Devices and Regenerative Technologies (2000), B-153 Progenitor and Stem Cell Therapy: Current Uses and Future Possibilities (2002), and B-162 Biomedical Applications of Nanoscale Devices (2003).
Dr. Edwards is Vice President, Technologies for Phaelixe, Inc., a consulting firm from Denver, CO., and consulted for a venture capital company. He is also the Program Chairman for the annual Nanotech and Biotech Convergence conference, hosted by BCC.
