Molecular Classification of Disease

Personalized medicine and pharmacogenomics were a major theme at the 6th International Biotech and Infotech summit this week in San Francisco. Pharmacogenomics is the correlation of a patient's genetic information to drug response, leading to "personalized" prescription of the most appropriate medicine.

Though the benefits of personalized medicine for patients is clear, many are concerned that efforts will be held back by the insurance industry and by pharmaceutical companies. Large pharmaceutical companies, in particular, are reputed to be resistant to the ideas of personalized medicine because this trend will herald the end of "blockbuster" drugs that drive pharmaceutical company profits as drugs become tailored to more specific, smaller markets.

But Dr. Gil Omenn had an interesting take on this issue. In a talk on connecting genomics technologies with patients, he reasoned that personalized medicines might have larger markets than we think because they will be treating a whole range of diseases that have an underlying molecular pathology.

The two "poster children" for personalized medicine are Novartis's (NYSE: NVS) Gleevec and Genentech's (NYSE: DNA) Herceptin. Both of these anti-cancer therapeutics are very effective in a limited patient population defined by a molecular phenotype. But both are experiencing market expansion beyond their initial indication. Gleevec, which inhibits the "abl" and the related "c-kit" kinases, is now being used to treat certain gastrointestinal tumors as well as chronic myelogenous leukemia. Herceptin is now being shown to be effective at treating many Her-2 positive tumors, not just breast cancers but also Her-2 positive ovarian and lung cancers.

Another example of a biotech drug expanding its market is IDEC's (NASDAQ: IDPH) Rituxan, which binds to the CD20 protein on the surface of B cells and B cell tumors. Rituxan has been very successful at expanding its use beyond the specific type of non-Hodgkin lymphoma for which it was originally approved. Recent data now suggest that it may also be useful at treating rheumatoid arthritis, a disease that involves hyperactive B cells. Perhaps it will eventually be used to treat other inflammatory conditions involving hyperactive B cells.

Classification of diseases by molecular and cellular characteristics is a compelling way to optimize the use of therapeutics that target specific molecular pathways. Johnson & Johnson's (NYSE: JNJ) Remicade and Immunex's (NASDAQ: IMNX) Enbrel, both inhibitors of the TNFalpha pathway, can be viewed as therapeutics that impact inflammatory diseases where TNFalpha is overproduced rather than being viewed as treatments for some but not all cases of rheumatoid arthritis, psoriasis, Crohn disease, etc. Rituxan can be used to treat diseases involving B cells. Already, Gleevec treats conditions characterized by overactive abl or c-kit, and Herceptin treats overactive Her-2. Perhaps we don't need a million different drugs for a million patients, bur rather a better understanding of the molecular basis of disease coupled with therapeutics that can target those very molecular processes. ______________________

BTECH NEWS
by Leon Henderson, M.D.
Bennett Weintraub, Ph.D.
Christopher Martin
www.btechnews.com
June 26, 2002

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BTECH NEWS, published by Btech Investor, Inc., highlights selected events in the life sciences sector that the Btech Investor team believes are particularly relevant to biotechnology investors. The Btech Investor team combines scientific, clinical, and business experience to perform comprehensive analysis of the biotechnology industry and to identify future industry leaders.

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