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Medco Announces Research Collaboration with FDA Focused on Personalized Medicine

Tuesday, August 19, 2008 General News J E 4
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FRANKLIN LAKES, N.J., Aug. 18 Medco HealthSolutions, Inc. (NYSE: MHS), the nation's leading pharmacy benefit manager,announced it and the Food and Drug Administration (FDA) have entered into aresearch partnership to study genetic testing and the impact of genetics onthe efficacy of prescription drugs. The announcement adds credence to theemerging science of personalized medicine and will expand the body of evidencefor the consideration of personal genetics in how doctors prescribe drugs.

Under the partnership, Medco and the FDA will jointly develop researchprojects, programs and strategies in the area of pharmacogenomics,collectively aimed at improving patient health and quality in the delivery ofcare. Pharmacogenomics is the science of capturing a patient's geneticinformation to help predict how a person is likely to respond to a widevariety of drugs, including commonly used prescriptions such as painrelievers, anticoagulants, and cancer drugs. This information has a bearingon what drug is selected and may help optimize doses for particular drugs.Commercial tests are currently available to identify the appropriateness ofspecific drug treatments based upon a patient's genetic profile.

"An increasing number of drugs are including genetic information in theirlabels and we're finding out how genes affect some drugs that have been widelyused for generations," said Medco's Chief Medical Officer Dr. Robert Epstein."Studying this field can advance pharmacy care to remove some of the trial anderror in how medications are prescribed."

Research Partnership

The research agreement extends to Aug. 31, 2010, during which time Medcowill deliver a series of reports to the FDA about pharmacogenomic testing.The topics to be studied will address the safety of prescription drugs,physician participation in pharmacogenomics testing, the usefulness of thetests in prescribing, and quantifying prescription information about drugsthat have genetic information in their labels. Medco's reports will bederived from clinical settings, including one that will examine whetherphysicians are willing to change the dose of a prescription based on a genetictest result. Medco's database of pharmacy claims will supply a large portionof the data to be used in the reports for the FDA.

"Medco's partnership with the FDA should help establish gene testing as atool to help lower health care costs and improve the quality of care," Epsteinsaid. "This will come from reducing waste from treatments that do not workand also from helping prevent unnecessary hospitalizations from incorrectdosages or other adverse drug events."

Medco plans on submitting portions of the research from this partnershipto peer-reviewed journals for publication with an eye on building the body ofevidence supporting the value of these tests.

Medco has existing research collaborations with Mayo Clinic studyinggenetic consideration in the use of warfarin, and with LabCorp regardingbreast cancer patients using tamoxifen. Completion of the tamoxifen study isexpected this year and the warfarin study is anticipated next year. Thecompany anticipates additional development partnerships with privatecompanies, academic institutions and other health care entities.

Pharmacogenomics revolution

Unique differences in an individual's genes can cause variations in howmany prescription drugs are metabolized in the body. These differences affectthe speed of which a patient metabolizes medication -- affecting safety orefficacy from too high or low of a dose. Such a situation can be dangerous orpotentially deadly in the case of common medications like warfarin or codeine.Approximately 30 percent of all medications are metabolized by one enzyme(CYP2D6). This opens up a far reaching range of genetic tests that could beused to determine how people will respond to a wide range of me
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