Genaissance Comments on FDA Guidance on Pharmacogenomics

Genaissance Comments on FDA Guidance on Pharmacogenomics
- Guidance Removes Regulatory Uncertainty and Encourages Broader Adoption of
Pharmacogenomics Toward Developing Safer, More Effective Medicines - 


NEW HAVEN, Conn., March 22  /PRNewswire-FirstCall/ -- Genaissance
Pharmaceuticals, Inc. (NASDAQ:GNSC), a leading developer and user of genetic
information to help guide medical therapy, applauds the U.S. Food and Drug
Administration's (FDA) newly-issued pharmacogenomics guidance.

The FDA Guidance for Industry on Pharmacogenomic Data Submissions specifies
when and how pharmacogenomic data needs to be submitted as part of applications
for marketing approval of new drugs, and eventually will enable safer and
better drugs to reach the market. The guidance also describes how
pharmacogenomic data will be utilized by the agency in regulatory
decision-making.  The Company anticipates that these clarifications will
increase the pharmaceutical industry's confidence level in pursuing marketing
approval of targeted medicines guided by an individual's genetic makeup, and
that pharmacogenomics will evolve into standard practice.

"The FDA's guidance is a significant step forward for the pharmacogenomics
industry, and provides a clear path for how to gain marketing approval of drugs
targeted by an individual's genetics," stated Kevin Rakin, President & CEO of
Genaissance.  "It represents an endorsement of pharmacogenomics as a promising
path for developing safer and more effective medicines."

Mr. Rakin said that he expects the FDA guidance to stimulate wider use of
Genaissance's fee-based clinical trial support services and also to streamline
its efforts in developing a portfolio of pharmacogenomically-guided drugs. "The
FDA's guidance removes much of the regulatory uncertainty surrounding
pharmacogenomic data submission, bringing us one step closer to realizing our
goal of commercializing high-value, genetically-targeted medicines," he added.

Adding to the Company's enthusiasm about the guidance, Jurgen Drews, MD,
Chairman of the Board of Directors of Genaissance, and former head of Global
R&D at Hoffmann-LaRoche, Inc., noted that, "The guidance creates a framework
for enriching the clinical development process, by bringing forth new kinds of
data and, over time, looking at how those data can lead all of us to better and
more effective medicines."

Current Applications -- Drug Rescue

The Company is among the first to apply pharmacogenomics to the development of
drugs that initially failed to demonstrate efficacy for a broad clinical trial
population but may prove to be effective for certain subgroups based on their
genetics.  The Company has acquired rights to vilazodone, a novel dual-action
antidepressant discovered by scientists at Merck KGaA, as its first example of
such a product.  Genaissance currently intends to develop vilazodone as a
targeted therapy for depression using Genaissance's pharmacogenomic technology.

Genaissance currently intends to apply its genotyping technology to identify
subjects in a Phase II study of vilazodone who are likely to respond to the
drug based on their genetics.  Genaissance believes that this should increase
the chances for a successful Phase III study and for the drug's ultimate
approval for use in an $18-billion antidepressant market currently
characterized by 'hit or miss' drugs.

Another of the Company's programs is aimed at improving the safety of
clozapine, which has long been accepted as one of the most effective
medications for treating schizophrenia.  The Company has discovered gene
variants that are likely to predispose schizophrenics to agranulocytosis, a
life-threatening side effect of clozapine.  Clozapine's use is severely limited
because of this risk and because of the accompanying arduous blood-monitoring
compliance procedures required for its use.  A simple DNA test for the gene
variants could greatly expand the number of patients who may benefit from
clozapine.

The guidance represents the results of a nearly three-year-long process that
incorporated input from the scientific community, the pharmaceutical industry
and the public, and is endorsed by the FDA Science Board.  The FDA states in
the guidance that the policies outlined therein are intended to assist in
advancing the field of pharmacogenomics in a manner that will benefit both drug
development programs and public health.

The FDA views the integration of pharmacogenomics into drug development as a
new, promising approach to identify sources of inter-individual variability in
drug response (both efficacy and toxicity); this will help individualize
therapy with the intent of maximizing effectiveness and minimizing risk.
Pharmacogenomics has also been one of the FDA's areas of focus for improving
regulatory procedures for more timely development of effective drugs.

The guidance anticipates fully integrating pharmacogenomic testing into drug
development and drug labeling, and outlines the regulatory procedures for
basing the dose selection, safety, or efficacy of a drug contingent upon the
performance of a pharmacogenomic test or tests.  The FDA's new pharmacogenomics
Web page is available at http://www.fda.gov/cder/genomics/default.htm.

Pharmacogenomics is the correlation of the unique features of a person's
genetic makeup with his/her response to a drug.  The field of pharmacogenomics
aims to develop better medicines through the incorporation of genetic
information in drug development and prescription to:  (1) protect patients from
receiving a drug that would be unsafe for them; and/or (2) determine prior to
prescribing that a drug will be effective for them.  The integration of
pharmacogenomics into the drug development process is leading to the
development of a new generation of therapeutic products that are safe and
effective for patients who can be identified upfront by using simple, DNA
diagnostic tests based on a blood sample or a cheek swab.

Pharmacogenomics may also help to reduce the cost of clinical trials and speed
their completion.  By enriching enrollment with subjects who display certain
genetic variations that are hypothesized to predispose these subjects to a
favorable response, the clinical trial process may then be refined to one that
requires smaller trials and produces more definitive results.

Genaissance Pharmaceuticals is a pioneer in developing pharmacogenomics-based
tools and technologies to better equip the pharmaceutical industry in its
efforts to develop safer and more effective drugs.

About Genaissance

Genaissance Pharmaceuticals, Inc. is developing innovative products based on
its proprietary pharmacogenomic technology and has a revenue-generating
business in DNA and pharmacogenomic products and services.  Genaissance also
markets its proprietary FAMILION(TM) Test, designed to detect mutations
responsible for causing Familial Long QT and Brugada Syndromes, two causes of
sudden cardiac death.  The Company's product development strategy is focused on
drug candidates with promising clinical profiles and finding genetic markers to
identify a responsive patient population.  This strategy is designed to enable
Genaissance to leverage existing clinical data and, thus, reduce the costs and
risks associated with traditional drug development and increase the probability
of clinical success and commercialization.  The Company's lead therapeutic
product, vilazodone for depression, is in Phase II of development.  For more
information on Genaissance, visit the company website at:
http://www.genaissance.com/.

This press release contains forward-looking statements, including statements
about the expected growth and development of Genaissance's business, such as
Genaissance's ability to effectively complete its vilazodone and clozapine
programs, detect associations between clinical outcomes and genetic variation,
the ability to assess how genetic variation can affect drug response, efforts
to build a drug candidate pipeline, the timing and outcome of its genetic
testing programs and the ability of Genaissance to apply its technologies to
the development, marketing and prescribing of drugs and Genaissance's ability
to detect associations between clinical outcomes and genetic variation.  Such
statements are subject to certain factors, risks and uncertainties that may
cause actual results, events and performance to differ materially from those
referred to in such statements, including, but not limited to, Genaissance's
ability to fund its drug development efforts, the extent to which genetic
markers (haplotypes) are predictive of clinical outcomes and drug efficacy and
safety, the attraction of new business and strategic partners, the adoption of
the Company's technologies by the pharmaceutical industry, the acceptance of
the Company's cardiac tests by health care providers, the timing and success of
clinical trials, competition from pharmaceutical, biotechnology and diagnostics
companies, the strength of the Company's intellectual property rights and those
risks identified in the Annual Report on Form 10-K for the year ended December
31, 2004, filed with the Securities and Exchange Commission on March 15, 2005,
and in other filings the Company makes with the Securities and Exchange
Commission from time to time.  The forward-looking statements contained herein
represent the judgment of Genaissance as of the date of this release.
Genaissance disclaims any obligation to update any forward-looking statement. 

DATASOURCE: Genaissance Pharmaceuticals, Inc.



CONTACT:  Richard S. Judson, Ph.D., Chief Scientific Officer, Senior Vice

President, R&D, [phone], , or Kevin Rakin

President & CEO, [phone], , both of Genaissance

Pharmaceuticals, Inc.; Rhonda Chiger (investors), Rx Communications,

[phone], ; Tom Redington (media), Redington, Inc.,

[phone], , both for Genaissance

Pharmaceuticals, Inc.



Web site:  http://www.genaissance.com/

http://www.fda.gov/cder/genomics/default.htm 

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