NEW HAVEN, Conn., March 22 /PRNewswire-FirstCall/ -- Genaissance Pharmaceuticals, Inc. , 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.
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.
Genaissance Pharmaceuticals, Inc.