Oncogenomics is a forthcoming study from Decision Resources, Inc., that evaluates the potential for genomics-based therapy to treat cancer. In another Decision Resources study, Genomics and Drug Development: Impact and Strategic Implications (due to publish in December, 2000), we found that there is little consensus among senior executives on a definition of genomics. In Oncogenomics, we will use Decision Resources' broad operational definition of genomics: the study and analysis of the genetic content of a given organism. We look at the pathways that are important in oncogenesis. The study of these pathways has yielded many new gene-based therapies-drugs that target the enzymes that lead to transformation, invasion, and metastasis. In addition, we look at how genomics is likely to change drug discovery and what experts expect from genomics-based therapies-drugs discovered using genome analysis.

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We limit our discussion to therapies aimed at breast, colorectal, ovarian, prostate, and lung (both small-cell and non-small-cell) cancers, non-Hodgkin's lymphoma, and the acute leukemias. The interest in these cancers as targets for drug development stems from their high prevalence in the seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) and their high levels of unmet need. For each of these cancers, we estimated the number of incident cases diagnosed at stages I, II, III, and IV for 1999, 2004, and 2009. We estimate that in 1999 physicians diagnosed approximately 1.7 million new cases of these cancers in the seven major pharmaceutical markets. By 2009, we expect this number to reach nearly 2.0 million, representing 1.4% annual growth in the number of incident cases.

Developers of a host of gene-based drugs are taking advantage of the relatively level playing field offered by the infant state of oncogenomics to test a variety of genomics-based candidates, including the following:

-- Agents targeting mutations in cell-growth signaling, such as Medarex's MDX-210, a monoclonal antibody formulation that stimulates immune system response (by simultaneously binding to the tumor cell and to monocytes and macrophages) against HER2/neu-overexpressing cells. The agent is in Phase II trials against ovarian, prostate, and kidney cancers.

-- Agents targeting signal transduction, such as Novartis's STI-517, which has received considerable recognition for its targeting of the Bcr-abl gene fusion in chronic lymphocytic leukemia. Novartis plans to expand the agent's indications.

-- Agents targeting cell cycle regulators, such as Aventis's flavopiridol, which has shown activity in Phase II trials, stabilizing disease in patients with chronic lymphocytic leukemia and non-small-cell lung cancer; Aventis plans launch dates for flavopiridol for these two cancers in 2002 and 2004, respectively.

-- Agents targeting programmed cell death, such as Genta's G-3139 (Genasense), the lead agent targeting the bcl-2 pathway mutations associated with lack of programmed cell death. Genasense, which has received fast-track designation from the FDA, is in Phase III trials against malignant melanoma.

We believe that peak-year sales exceeding $1 billion will eventually be achievable by broad-spectrum genomics-based drugs, no matter if the drugs are incorporated into a consensus-based therapy model or a personalized medicine model. Nevertheless, we do not believe that a genomics-based blockbuster will be seen until after 2004, when diagnostics technology will have improved the oncology community's ability to stratify patients into treatment-specific groups. Thus, the window of opportunity in genomics-based cancer therapy remains open for those pharmaceutical developers agile enough to capitalize on the identification of the genetic causes of cancer.

Oncogenomics is part of Onkos, one of six Pharmacor services that evaluate the commercial potential of drugs in research and development.

Decision Resources, Inc., is a world leader in pharmaceutical research publications, advisory services, and consulting designed to help clients shape strategy, allocate resources, and master their chosen markets. Founded as a subsidiary of Arthur D. Little, Inc., the company has provided strategic information services for 30 years.

Contact: Frank Sama, 781.487.3753 (telephone), 781.487.5750 (fax), or sama@dresources.com (e-mail). In Europe, contact Francoise Bidart, +32.2.351.4082 (telephone), +32.2.351.2347 (fax), or fbidart@decisionresources.be (e-mail). In Japan, contact Makiko Yoshimoto, +81.3.5401.2615 (telephone), +81.3.5401.2617 (fax), or makiko@bl.mmtr.or.jp (e-mail). http://www.dresources.com

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SOURCE: Decision Resources, Inc.

Contact: Frank Sama of Decision Resources, 781-487-3753,

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