Celera and Medco Enter Research Collaboration to Evaluate Effect of K1F6 Testing on Compliance with Statin Therapy in Patients with Cardiovascular Disease
ALAMEDA, CA, and Franklin Lakes, NJ, - September 22, 2009
Celera Corporation (NASDAQ:CRA) and Medco Health Solutions, Inc. (NYSE:MHS), today announced that they have entered into a research collaboration to evaluate whether testing for a gene variant called KIF6 increases patient adherence with statin therapy. Current studies have suggested that only about 50 to 60 percent of the patients who receive a prescription for a lipid-lowering drug are taking the medication after six months1. This level of adherence falls to 30 to 40 percent after two years in patients with coronary artery disease2.
“A study of this nature has the potential to show that understanding your genetic risk can improve statin adherence,” said Medco Vice President of Personalized Medicine Research and Development Dr. Felix Frueh. “Medco's research partnership with Celera could help provide more evidence that personalized medicine can improve patient outcomes.”
As part of this collaboration, the companies will conduct a prospective, randomized, open-label, multi-center study (AKROBATS – Additional KIF6 Risk Offers Better Adherence to Statins) to address the primary question of whether patient adherence with newly prescribed statin therapy is higher in those patients tested for KIF6 status than in those who are not offered the test. Medco expects to test approximately 650 members for their KIF6 status and compare adherence with statin therapy to an equally-sized control group whose KIF6 status is not known. Samples will be collected by using a simple cheek swab. Testing will be performed by Berkeley HeartLab, Inc., a Celera subsidiary, using its laboratory developed test. Following review and approval by an Institutional Review Board, the study is expected to begin this fall, and patients' statin adherence is expected to be monitored by Medco's current pharmacy benefit methods over the course of 18 months.
“We believe this research collaboration presents an opportunity to demonstrate an important benefit of genetic testing as we hope to show that carriers of the KIF6 variant are more likely to adhere with their physician-prescribed statin treatment,” said Celera Chief Executive Officer Kathy Ordoñez.
All patients included in the study will be under the care of a physician who has already prescribed them a statin. The primary endpoint of this study is change in adherence to statin therapy in patients tested for KIF6 status compared to statin-treated patients who do not undergo KIF6 testing.
Medco has established a Personalized Medicine Program that offers solutions for payors to help enable them to leverage the potential advantages of personalized medicine by analyzing prescription claims histories to identify patients who could benefit from genetic testing, communicating with physicians about testing options and results and engaging patients to educate them about genetic tests. Outcomes from the current collaboration are expected to further strengthen this program.
The KIF6 gene encodes kinesin-like protein 6 ( KIF6 ). Published research studies have shown an association between KIF6 and cardiovascular risk and statin benefit3-7.
Statins are the most potent cholesterol-lowering agents available, which can help prevent heart attacks and strokes. Approximately 20 percent of Americans are prescribed a statin each year and are the most prescribed class of drugs in the United States , according to 2008 IMS data.
Celera is a healthcare business focusing on the integration of genetic testing into routine clinical care through a combination of products and services incorporating proprietary discoveries. Berkeley HeartLab, a subsidiary of Celera, offers services to predict cardiovascular disease risk and improve patient management. Celera also commercializes a wide range of molecular diagnostic products through Abbott and has licensed other relevant diagnostic technologies developed to provide personalized disease management in cancer. Information about Celera Corporation, including reports and other information filed by the company with the Securities and Exchange Commission, is available at http://www.celera.com.
Copyright© 2009. Celera Corporation. All Rights Reserved. Celera is a registered trademark of Celera Corporation or its subsidiaries in the U. S. and/or certain other countries.
Certain statements in this press release are forward-looking. These may be identified by the use of forward-looking words or phrases such as “believe,” “expect,” “will,” “should,” “anticipate,” “may,” “could,” and “intend,” among others. These forward-looking statements are based on Celera's current expectations. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for such forward-looking statements. In order to comply with the terms of the safe harbor, Celera notes that a variety of factors could cause actual results and experience to differ materially from the anticipated results or other expectations expressed in such forward-looking statements. The risks and uncertainties that may affect the operations, performance, development, and results of our business include, but are not limited to, the risks and uncertainties that: (1) the risk that the agreement with Medco may be terminated; (2) the risk that the study contemplated by this collaboration may not advance as anticipated or show that KIF6 carriers are more likely to comply with statin therapy; and (3) the uncertainty that any products or services will be accepted and adopted by the market, including the risk that that our products or services will not be competitive with products or services offered by other companies, or that users will not be entitled to receive adequate reimbursement for these products or services from third party payors such as private insurance companies and government insurance plans. The foregoing list sets forth some, but not all, of the factors that could affect Celera's ability to achieve results described in any forward-looking statements. For additional information about the risks and uncertainties that Celera faces and a discussion of its financial statements and footnotes, see documents filed by Celera with the SEC, including its transition report on Form 10-KT and all subsequent periodic reports. All information in this press release is as of the date of the release, and Celera does not undertake any duty to update this information, including any forward-looking statements, unless required by law.
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 more than 60 million Americans.
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 2008 revenue exceeding $51 billion, Medco ranks 45th 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 .
1. ATP III. Third Report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III) final report. Circulation. 2002;106:3143-3421.
2. Jackevicius CA, Mamdani M, Tu JV. Adherence with statin therapy in elderly patients with and without acute coronary syndromes. JAMA 2002;288:462-7.
3. Morrison AC et al. Prediction of coronary heart disease risk using a genetic risk score: the Atherosclerosis Risk in Communities Study. Am J Epidemiol. 2007; 166(1):28-35.
4. Iakoubova OA et al. Association of the Trp719Arg polymorphism in kinesin-like protein 6 with myocardial infarction and coronary heart disease in 2 prospective trials: the CARE and WOSCOPS trials. J Am Coll Cardiol. 2008; 51(4):435-43.
5. Shiffman D et al. Association of gene variants with incident myocardial infarction in the Cardiovascular Health Study. Arterioscler Thromb Vasc Biol. 2008; 28(1):173-9.
6. Shiffman D et al. A kinesin family member 6 variant is associated with coronary heart disease in the Women's Health Study. J Am Coll Cardiol. 2008; 51(4):444-8.
7. Iakoubova OA et al. Polymorphism in KIF6 gene and benefit from statins after acute coronary syndromes: results from the PROVE IT-TIMI 22 study. J Am Coll Cardiol. 2008; 51(4):449-55.
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