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BiDil Maker NitroMed Responds to "Race In A Bottle"

The Science Behind BiDil

The landmark study, AHeFT, showed BiDil® (isosorbide dinitrate/hydralazine) to be a major medical advance in treating heart failure in African Americans. A "placebo"-treated group of heart failure subjects were administered current standard heart failure therapies, and compared to BiDil-treated subjects who were administered current standard heart failure therapies plus BiDil. A-HeFT showed that BiDil provides a profound mortality benefit, reduction in first hospitalizations for heart failure, and improvement in patients functional status for a lethal disease that disproportionately burdens blacks. As we continue to learn more about BiDil's clinical utility as adjunct therapy in treating heart failure, our commitment remains steadfast in making BiDil broadly accessible, for the benefit of African American heart failure patients and their families. The peer-reviewed, published studies below illustrate the extent and value BiDil's effects in heart failure patients.

But paramount is that A-HeFT unassailably proved that the group receiving BiDil—on top of all standard heart failure therapy—had a survival improvement of 43%. If all eligible patients were on BiDil, AHeFT shows that 30,000 lives would be saved per year and about 99,000 costly and burdensome hospitalizations could be avoided. Indeed, A-HeFT was stopped months earlier than originally planned because the independent data safety monitoring board observed marked decreased mortality in the BiDil-treated group of subjects. From that moment on, it was deemed that ethical medical treatment of black heart failure patients' regimen of medicines includes BiDil therapy.

Race is an uncomfortable proxy for medical treatment. NitroMed does not employ the phrase 'race-based medicine.' It is a term others have coined and we think it is offensive and dismisses the scientific foundation of BiDil's development. We make a medicine that was shown to be tremendously beneficial to a vulnerable sub-population. And because of the sub-population's vulnerability and unmet medical need, AHeFT was carefully designed in collaboration with the Association of Black Cardiologists. It included the largest number of black heart failure patients ever studied, and the largest number of black women ever to participate in any clinical trial. Indeed, A HeFT represents a ground- breaking example of a trial including a meaningful number of African American subjects. The FDA promulgated regulations for the collection and reporting of racial and ethnic data in investigational and marketing applications for new drugs beginning in 1998. In the 2005 guidance document associated with these regulations, FDA states that "(d)ifferences in response to medical products have already been observed in racially and ethnically distinct subgroups of the U.S. population. These differences may be attributable to intrinsic factors (e.g., genetics, metabolism, elimination), extrinsic factors (e.g., diet, environmental exposure, socio-cultural issues), or interactions between these factors."1

The Genetic Risk Assessment in Heart Failure Trial (GRAHF), a prospectively defined genetic analysis of A-HeFT patients, was developed to help identify specific, shared biomarkers within patient cohorts to delineate additional subsets where BiDil may also be effective. In GRAHF, researchers are examining the genetic variation of a number of genes important for cardiovascular diseases, collected from 358 A-HeFT patients to determine a potential correlation between specific genetic biomarkers and the positive A-HeFT results. African American patients were compared with white heart failure subjects from the Genetic Risk Assessment of Cardiac Events (GRACE) study at the University of Pittsburgh.

Initial results from GRAHF indicate that a marked difference exists in the make up of several genes in self-identified black patients versus white patients. Researchers found that a majority of black patients possess a specific gene variation that was observed in less than half of the white cohort from GRACE. In the subset of black patients, the benefit of BiDil therapy on the primary composite score from A-HeFT—combining mortality, heart failure hospitalization and patient functional status—was primarily seen in those possessing the specific gene variation observed in GRAHF. Investigators hope the identification of specific genetic variants may help identify other heart failure patients who may receive a greater benefit from BiDil. More comprehensive results from GRAHF are expected.

Fortunately, the benefit of this evidence-based medicine is available now and access is broad and affordable. We are very proud to be associated with the development and commercialization of BiDil.

1 Office of the Commissioner, Center for Devices and Radiologic Health, Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research, Food and Drug Administration, U.S. Department of Health and Human Services, Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials, September 2005.

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