Recent Advances in the Fast-Growing Molecular Diagnostics Industry

Published by: Decision Resources

Published: Sep. 12, 2007 - 22 Pages

Table of Contents

Executive Summary

Strategic Considerations

Stakeholder Implications

Immunology-Based Cancer Treatment: Building on the Promise of the Past

Mobilizing the Human Immune System: Back to the Future

Observations in Bladder Cancer Patients

Observations in Melanoma Patients

Marketed Immunomodulatory Oncology Drugs

Novartis’s Proleukin

Roche’s Roferon-A and Schering’s Intron-A

Thalidomide and Thalidomide Derivatives

Thalidomide

Celgene’s Thalidomide Derivatives

Revlimid (Lenalidomide)

CC-4047

CC-11006

Small-Molecule Drugs that Modulate Toll-Like Receptors

3M Pharmaceuticals’ Aldara

3M Pharmaceuticals’ 852A

Coley Pharmaceuticals/Pfi zer’s PF-3512676

Dynavax Technologies’ 1018 ISS

Idera Pharmaceuticals’ IMOs

Mologen’s dSLIM

Biologics That Modulate T-Cell Costimulation

CTLA-4 Antagonists

Amgen/Pfi zer’s Tremelimumab

Medarex/Bristol-Myers Squibb’s Ipilimumab

CD28 Superagonist TGN1412

Outlook

Tables:

1. Marketed Nonspecifi c Immunomodulatory Drugs for Cancer

2. Celgene’s Immunomodulatory Products for Cancer Indications

3. Toll-Like Receptor Agonists in Clinical Development for Cancer Treatment, 2007

4. T-Cell Costimulation Modulating Biologics in Development for Cancers

5. Potential Reasons for the Pathogenic Effect of TGN1412 in Humans

Figures:

1. Chemical Structures of Thalidomide and Lenalidomide

2. Mechanisms of T-Cell Costimulation

Sidebar:

Thalidomide Derivatives vs. Thalidomide: How Is Cancer Immunomodulation Best Achieved?

Abstract

• The MDx market can be segmented into three phases: infectious diseases; blood screening; and pharmacogenomic testing, genetic testing, predictive testing, and companion diagnostics. Why does scope for greater innovation and greater sales potential lie in the third phase?
• According to industry experts, polymerase chain reaction (PCR) technology will have the greatest impact on the MDx market. PCR enables researchers to amplify minute amounts of genetic material to billions of copies in a matter of hours through repeated cycles of duplication via the use of an enzyme called DNA polymerase or Taq polymerase. What big pharma company used PCR to become one of the most powerful leaders in the fi eld of MDx?
• Pharmaceutical companies have traditionally been reluctant to employ MDx (e.g., to identify biomarkers) to screen drug candidates during the R&D process for fear of reducing the potential target population. Why is this attitude changing?
• Big pharmaceutical companies and smaller MDx companies are teaming up to produce MDx technologies. What alliances have been formed, and what products have been the result?

• The three phases of MDx: infectious diseases; blood screening; and pharmacogenomic testing, genetic testing, predictive testing, and companion diagnostics.
• MDx technologies: PCR, DNA methylation, and RNAi validation.
• MDx platforms: Microarrays, nanoarrays, microfl uidics, and multiplex assays.
• Major players: Roche Diagnostics, Abbott Diagnostics, and Siemens Medical Solutions Group.
• Expert Commentary: Dr. John Sninsky, vice president of discovery research at Celera, and Dr. David Speechly, Media and Investor Relations at Celera, discuss Celera’s involvement in MDx.

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