How to Succeed in Personalized Medicine by Using Tools and Technologies

by Sam Tetlow, M.B.A.

Published: January, 2006

Introduction

The application of pharmacogenomics in drug development is widespread today in differing degrees of intensity. Pharmacogenomics has recently seen an inflection point that pharmaceutical and biotechnology companies need and want to understand. Given recent issues with Cox-2 inhibitors and anti-depressants, the FDA is increasingly focused on bringing personalized medicine to this area. Advances in patents and technology are occurring at a faster rate than ever before. The first FDA approved test in this area was for the Roche and Affymetrix 2D6 GeneChip.

One of the major issue facing large pharmaceutical and medium biotechnology companies is how to incorporate pharmacogenomic technology into the drug model. The three major opportunities being pursued in the industry to perpetuate and improve the drug sales model include targeted therapies, product extensions and ultra-blockbusters.

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Report Overview

D&MD's How to Succeed in Personalized Medicine by Using Tools and Technologies report provides the market with a clear understanding of the regulatory and commercial actions influencing the industry. This report analyzes the elements shaping this market and offers an intensive investigation of pharmacogenomic business issues, including:

Analysis on the regulatory impact for submitting pharmacogenomics data using FDA's 2005 Guidance for Industry

How companies are now adopting genotyping and pharmacogenomics

Why big pharma is selectively making bets on personalized medicine using innovative business structures that have long-term implications for all large pharma

Details on varying forms of pharmacogenomics success highlighting key elements from the pharmaceutical value chain

Requirements for market adoption in the pharmaceutical industry

The report offers 40 industry interviews and survey results compiled companies of all types that show an inflection point in 2006 in personalized medicine, where the industry believes approximately 39 percent of drugs will be influenced in any of pre-clinical, clinical, or on-market activities in 2006. This inflection point will be driven by emerging biotechnology companies. However, industry believes that over time, large pharma will be the driving force for adoption.

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Market Opportunities

The focus of pharmacogenomics is currently selecting targets that are genetically validated even before genomic validation begins, attacking attrition early in development (Phase I and II), addressing adverse reactions in Phase III, and supporting a standardized system of post-launch surveillance with regulatory oversight. Addressing attrition earlier in the drug development process can have a huge impact on development cost. Indeed, moving just 10 percent of Phase III failures to Phase I reduces the average total cost of developing a drug by $98 million.

There is considerable concern in the industry, and on Wall Street, that the net impact of the introduction of pharmacogenomics will be negative. Yet, the economic and the logistical arguments for not implementing pharmacogenomics are not sound. The average sales of a conventional drug are approximately $63 million lower than for a pharmacogenomics-developed drug. Assuming a 30-year revenue lifecycle, the Net Present Value (NPV) of the pharmacogenomics drug is approximately $85 million higher than the conventional drug.

Company Profiles

Affymetrix, Inc.

DXS Genotyping Services

Incyte Corporation

Sequenom, Inc.
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