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SureGene, LLC and the Medco Research Institute Enter a Collaboration to Evaluate the Ability of Genetic Biomarkers to Enhance Drug Selection for Serious Mental Health Illnesses



8/24/2010 8:49:30 AM

LOUISVILLE, Ky. and FRANKLIN LAKES, N.J., Aug. 24 /PRNewswire/ -- SureGene, LLC and the Medco Research Institute, LLC, a wholly-owned subsidiary of Medco Health Solutions, Inc. (NYSE: MHS), today announced that they have entered into a novel investigative research collaboration to evaluate whether variation in genetic biomarkers previously identified by SureGene can help predict drug response for widely prescribed antipsychotic drugs in patients with serious mental illness. The results of this research could help provide evidence supporting the development of genetic tests that would assist doctors to make more precise prescribing decisions, leading to improvements in outcomes, compliance and safety for these mental health patients.

(Logo: http://photos.prnewswire.com/prnh/20100609/MEDCOLOGO )

(Logo: http://www.newscom.com/cgi-bin/prnh/20100609/MEDCOLOGO )

Choosing the correct antipsychotic medication for patients suffering from severe psychiatric illness is a major challenge. When patients are not prescribed an effective antipsychotic drug, they are at an elevated risk of experiencing a serious adverse drug event. Current studies have suggested that less than one in three patients suffering from schizophrenia and related disorders will have an improvement in symptoms on the first antipsychotic drug prescribed. Poor response to treatment and the side effects of antipsychotic drugs can also result in low compliance, with 50 percent of patients discontinuing drug use within six months of starting a prescription. High discontinuation and poor compliance often results in hospitalization. While there are no currently marketed ways to identify which antipsychotic drug is optimal for a given patient, SureGene's genetic test has demonstrated the ability to stratify drug efficacy of atypical antipsychotics, such as olanzapine and risperidone.

Through their collaboration, the companies will conduct the REST study Relative Effectiveness of Schizophrenia Therapy a prospectively designed clinical trial to further validate SureGene developed genetic biomarkers as predictors of efficacy and safety for commonly used atypical antipsychotics in the treatment of serious mental illness. In addition, the collaboration will evaluate the cost effectiveness of using SureGene biomarkers as a standard part of future clinical care for mental illness. Key to these objectives, Medco expects to collect 2,000 DNA samples obtained from plan members who agree to participate in the REST study.

"The REST study provides us an exciting opportunity to validate our technology in a real world setting. It has the potential to move us closer to making a real difference in the lives of people suffering from serious psychiatric illnesses using genetic information to guide drug selection," said Dr. Mark Brennan, SureGene's Chief Scientific Officer.

Personalized medicine is an area of healthcare that is becoming more widely used to focus on how a person's genetic makeup can affect their ability to respond to medications, allowing physicians to make more effective and safe selection or dosing of a drug with the benefit of this additional genetic information.

"A study of this nature has the potential to show that understanding a patient's genetic risk with the help of a diagnostic test can improve antipsychotic drug selection, efficacy, safety and compliance," said Medco Vice President of Personalized Medicine Research and Development, Dr. Felix Frueh. "Medco's research partnership with SureGene could help provide evidence supporting the development of a genetic test that may assist physicians to make a personalized treatment decision for patients with these serious diseases."

This study with SureGene is Medco's first personalized medicine research effort in the area of mental illness. Medco has also conducted extensive personalized medicine research regarding genetic factors affecting patient responses to medications used for the treatment of cardiovascular disease, such as warfarin (Coumadin®) and clopidogrel (Plavix®).

As a scientifically-driven healthcare company, Medco recently underlined its commitment to research by announcing plans to acquire United BioSource Corporation (UBC). UBC is one of the world's most respected sources of post-approval drug and device research focused on accelerating the generation of critical pharmaceutical knowledge to advance patient safety and to further evidence-based medicine. The acquisition is subject to regulatory reviews and approvals, and is expected to close in the third-quarter of 2010.

About Schizophrenia and Bipolar Disorder

Schizophrenia is characterized by psychotic symptoms including delusions, hallucinations, disorganized thinking and cognitive impairment. Poor response to drug treatment and the side effects of antipsychotic drugs can also result in low compliance, with 50% of patients discontinuing drug use within six months of starting a prescription. High discontinuation and poor compliance often results in hospitalization. Bipolar Disorder is characterized by two main types of mood disturbances, with depression being the most common type and mania, or hypomania less frequent.

About SureGene

SureGene is a healthcare business focusing on personalized medicine for mental health. SureGene's technology can be used to identify genetic variations in sub populations that correlate with important safety factors, lack of effect as well as improved response to antipsychotic drugs, segment clinical trials to enhance performance of antipsychotic and other drugs relative to active comparators, identify targets for drug repurposing and identify novel targets for drug development. For more information, go to http://www.suregene.net.

About Medco Research Institute

Medco Research Institute is an evidence-based research organization focused solely on novel research, analytics and new discoveries that close the gap between scientific discovery and medical practice for improved patient outcomes and lower overall healthcare costs. More information about the Medco Research Institute's peer-reviewed research can be found at www.medcoresearchinstitute.com.

About Medco

Medco Health Solutions, Inc. (NYSE: MHS) is pioneering the world's most advanced pharmacy® and its clinical research and innovations are part of Medco making medicine smarter for approximately 65 million members.

With more than 20,000 employees dedicated to improving patient health and reducing costs for a wide range of public and private sector clients, and 2009 revenues of nearly $60 billion, Medco ranks 35th on the Fortune 500 list and is named among the world's most innovative, most admired and most trustworthy companies.

For more information, go to http://www.medcohealth.com.

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that may cause results to differ materially from those set forth in the statements. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the risks and uncertainties that affect our business, particularly those mentioned in the Risk Factors section of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission.

SOURCE Medco Research Institute


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