Abstract
Pressure to Optimize Drug Discovery Drives Adoption
Considering that the development of a single drug costs an average of $500
million and that only 30 percent of approved drugs even recover these costs,
the pharmaceutical industry is under growing pressure to streamline and
optimize the identification of novel therapeutics. In addressing this need,
pharmacogenomic profiling has the potential not only to increase the
efficiency and speed with which new medicines are developed, but also to
improve diagnostics for drugs already in the market. As a result, there is a
growing awareness among pharmaceutical and biotechnology companies about the
benefits of using pharmacogenomics in the selection of compounds with a
favorable safety and efficacy profile.
This Frost & Sullivan research service provides technical insights into
developments in pharmacogenomics. This analysis reviews technologies that are
expected to impact the pharmacogenomics industry and includes coverage of key
participants and their developments. The study distinguishes itself by
focusing on user concerns by examining the practical and pragmatic
applications of emerging technologies.
NitroMed looking at Identifying Genes Involved in the Positive Response to its Heart Failure Drug, BiDil
Among the notable developments related to pharmacogenomics research in North
America, NitroMed is focusing on determining the genes involved in the
positive response to its BiDil, a drug that remedies heart failure. This
orally-administered medication, which enhances nitric oxide levels in the body
and protects the compound after it is formed, was developed on the basis of
pharmacogenomic evidence that suggests that African American heart failure
patients often suffer from a greater deficiency of nitric oxide than
non-African Americans. After their initial setbacks, the company successfully
conducted clinical trials on 1,050 African American patients and in June 2005,
the Food and Drug Administration (FDA) voted to recommend approval of BiDil
for the treatment of heart failure in African American patients. Encouraged by
this approval, the company is now conducting pharmacogenomic studies to
determine the genes that might be involved in the positive response to BiDil.
Researchers are looking at the endothelial nitric oxide synthase (NOS3) gene,
which encodes the nitric oxide synthesizing enzyme in the heart as well as
vasculature and is important in treating hypertension and heart failure
"In Europe, the UK-based Solexa is developing genome sequencing systems for a
comprehensive and economical analysis of individual genomes, which can be used
in a wide range of applications from basic research to the development and
implementation of personalized medicine," notes the analyst of this research
service. "The long-term goal of this project is to reduce the cost of human
resequencing to a few thousand dollars, thus providing an individuals total
genetic information for less than the cost of a CT scan."
Pharmacogenomics Hold Tremendous Potential in Reducing Market Withdrawals
Apart from bringing about improvements in drug discovery and approvals, the
potential benefits of pharmacogenomics are likely to extend even after FDA
approvals. In the last decade, a considerable number of approved drugs,
including Vioxx, Rezulin, Pondimin, Redux, Propulsid, Seldane, Posicor, and
Baycol (Cerivastatin) have been withdrawn from the market. In most cases, the
withdrawal was precipitated by adverse effects that occurred in less than 0.1
percent of patients receiving the drug. Examining genetic variation provides
the opportunity to uncover genotype-phenotype correlations that may allow the
exclusion of a subset of at-risk individuals.
"Despite the explosive growth in proteomics, genetic information is expected
to continue playing a major role in healthcare and drug discovery," says the
analyst. "Pharmacogenomic testing (research, clinical, and diagnostic) is one
of the fastest growing sectors of healthcare and its market potential is
projected to grow to 3-4 billion dollars by the end of this year."
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