New BiDil Data Highlighted at Annual Heart Failure Society of America Meeting.

LEXINGTON, Mass. -- NitroMed, Inc. (NASDAQ:NTMD) announced today that five poster presentations highlighting new findings related to BiDil(R) (isosorbide dinitrate/hydralazine hydrochloride) will be presented at the 10th Annual Meeting of the Heart Failure Society of America (HFSA), being held at the Washington State Convention & Trade Center in Seattle, from September 10 - 13th. BiDil is currently marketed by NitroMed's sales force as adjunctive treatment for African Americans with heart failure. The drug was approved in June 2005 on the basis of outstanding clinical results from the Company's African American Heart Failure Trial (A-HeFT). Ongoing analyses of patient data from A-HeFT continue to provide valuable insight into how and in whom BiDil may provide treatment benefit.

One notable BiDil presentation demonstrates longer-term compliance with the fixed-dose combination drug, as well as continued efficacy, safety and tolerability. A second presentation highlights a particular genotype of the G protein beta 3-subunit (GNB3 TT) that is closely associated with positive results in A-HeFT, providing a basis for further study for the role of the genotype in targeting therapy. A third presentation demonstrates a survival benefit amongst post-menopausal women who received BiDil in A-HeFT. Although the mechanism of action of BiDil has not been completely established, the drug is believed to stimulate and maintain nitric oxide signaling and post-menopausal women are believed to have lower vascular nitric oxide activity. A fourth presentation shows cardiac mortality as the most common cause of death in African American heart failure patients. BiDil significantly decreased cardiac death by decreasing pump failure deaths in the moderately severe A-HeFT heart failure population. This is consistent with previously reported significant reductions in all-cause mortality and heart failure hospitalizations for BiDil treated patients in A-HeFT. The fifth presentation suggests that while BiDil was superior to placebo with or without use of beta blockers or angiotensin converting enzyme (ACE) inhibitors, there appears to be further benefit in the group treated with BiDil and beta blockers than without beta blockers.

Abstracts of the BiDil presentations are available at www.hfsa.org. A synopsis of the abstract titles and conclusions follow:

(260) Results of the Extension to A-HeFT (X-A-HeFT) Support the Continued Safety and Tolerability of BiDil

Conclusion: The results of the open label extension study of BiDil, X-A-HeFT, demonstrate a high level of compliance, duplicate the low mortality and support continued safety and tolerability of treatment with BiDil previously noted in A-HeFT. Headaches and dizziness were significantly lower than observed in A-HeFT.

(227) GNB3 TT Genotype Predicts Enhanced Benefit of BiDil in African Americans with Heart Failure: Results of the A-HeFT Trial

Conclusion: A common polymorphism (C825T) exists in exon 10 of the gene for the G protein beta 3 subunit. The GNB3 TT genotype prevalent in African Americans and associated with increased alpha adrenergic signaling was characterized by a more pronounced effect of BiDil on a composite score, functional status (quality of life) and event-free survival in A-HeFT.

(278) Administration of BiDil Is Associated with Improved Outcomes in Post-Menopausal Women

Conclusion: BiDil added to standard therapy significantly improved survival and event-free survival in women in A-HeFT. BiDil was also found to have a benefit on survival and event-free survival in the post-menopausal group.

(243) Mode of Death in African American (AA) Heart Failure (HF) Population

Conclusion: In AA patients with NYHA class III and IV HF, cardiac mortality was the most common cause of death, principally due to sudden cardiac death (SCD) and pump failure (PF) death. BiDil decreases cardiac mortality by decreasing PF deaths in this moderately severe HF population. This finding is consistent with the marked reduction in all-cause mortality and HF hospitalizations previously reported with BiDil in A-HeFT.

(259) Effect of Angiotensin Converting Enzyme Inhibitor or Beta-Blocker Use on the Benefit of BiDil in the African-American Heart Failure Trial

Conclusion: Based on the analysis of baseline medications use in A-HeFT, BiDil was superior to placebo with or without beta blocker or angiotensin converting enzyme (ACE-I) use. However, beta blocker but not ACE-I provided additional benefit to African Americans with heart failure treated with BiDil. These analyses are hypotheses generating and would need to be investigated in prospective trials.

About BiDil

BiDil is indicated for the treatment of heart failure as an adjunct to current standard therapy in self-identified black patients, to improve survival, prolong time to hospitalization for heart failure and improve patient-reported functional status. There is little experience in patients with New York Heart Association (NYHA) class IV heart failure. Most patients in the clinical trial supporting effectiveness, referred to as A-HeFT, received, in addition to BiDil or placebo, a loop diuretic, an angiotensin converting enzyme inhibitor or an angiotensin II receptor blocker, and a beta blocker, and many also received a cardiac glycoside or an aldosterone antagonist. BiDil is a fixed-dose combination of isosorbide dinitrate and hydralazine hydrochloride. While the exact mechanism of action underlying the beneficial effects of BiDil in the treatment of heart failure is unknown, it is known that isosorbide dinitrate is a vasodilator with effects on both arteries and veins. The dilator properties of nitrates result from the release of nitric oxide that leads to the relaxation of vascular smooth muscle. Hydralazine is an arterial vasodilator.

In A-HeFT, self-identified black patients taking BiDil in addition to current standard heart failure therapies experienced a significant 43 percent decrease in the risk of mortality (P=.012) (absolute mortality rate: BiDil, 6.2% vs. placebo, 10.2%), a 39 percent reduction in the risk of first hospitalization for heart failure (P less than .001) (absolute first hospitalization rate: BiDil, 16.4% vs. placebo, 24.4%) and a statistically significant improvement at most time points in response to the Minnesota Living with Heart Failure Questionnaire, which is a self-report of the patient's functional status, versus patients taking placebo in addition to current standard therapies.

Heart Failure Burden in Black Patients

Heart failure, or end-stage cardiovascular disease, affects approximately five million Americans, including an estimated 750,000 African Americans. Each year, over 550,000 people are diagnosed with heart failure for the first time, and there is no cure for this disease - with more than 50 percent of patients dying within five years of diagnosis. With respect to heart failure, blacks are affected at a rate greater than that of the corresponding non-black population, presenting with the disease earlier and dying sooner. According to the Centers for Disease Control and Prevention (CDC), African Americans between the ages of 45 and 64 are 2.5 times more likely to die from heart failure than Caucasians in the same age range.

Important Safety Information

BiDil is contraindicated in patients who are allergic to organic nitrates. Augmentation of the vasodilatory effects of isosorbide dinitrate by phosphodiesterase inhibitors (e.g., Viagra(R)/Revatio(TM), Levitra(R), Cialis(R)) could result in severe hypotension.

Treatment with hydralazine may produce a clinical picture simulating systemic lupus erythematosus (SLE) including glomerulonephritis. If SLE-like symptoms occur, discontinuation of BiDil should be considered.

Residua have been detected many years after discontinuation of hydralazine. Symptomatic hypotension may occur with even small doses of BiDil. BiDil should be used with caution in volume depleted or hypotensive patients. Hydralazine can cause tachycardia potentially leading to myocardial ischemia and anginal attacks. Hydralazine hydrochloride has been associated with peripheral neuritis, evidenced by paresthesia, numbness and tingling, which may be related to an antipyridoxine effect. Caution should be exercised if BiDil is used with MAO inhibitors, alcohol, sildenafil, vardenafil or tadalafil.

Headache (50%) and dizziness (32%) were the two most frequent adverse events and were more than twice as frequent in the BiDil group.

Viagra is a registered trademark and Revatio is a trademark of Pfizer, Inc.; Levitra is a registered trademark of Bayer HealthCare, GlaxoSmithKline, and Schering-Plough; Cialis is a registered trademark of Lilly ICOS LLC.

About NitroMed, Inc.

NitroMed of Lexington, Massachusetts is an emerging pharmaceutical company and the maker of BiDil(R) (isosorbide dinitrate/hydralazine hydrochloride), an orally administered medicine that may be prescribed in the United States for the treatment of heart failure in self-identified black patients. In this population, BiDil is indicated as an adjunct to current standard therapies such as ACE inhibitors and/or beta blockers. BiDil was approved by the U.S. Food and Drug Administration, primarily on the basis of efficacy data from the Company's landmark A-HeFT (African American Heart Failure Trial) clinical trial.

Forward Looking Statements

Statements in this press release about future expectations, plans and prospects for the Company, including statements regarding the Company's expectations about the potential benefits of BiDil, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the potential impact of new data derived from A-HeFT, if any, on the use of BiDil; the Company's ability to obtain regulatory approval with regard to new clinical data; patient, physician and third-payer acceptance of BiDil as a safe and effective therapeutic; the Company's ability to obtain preferential reimbursement treatment for BiDil, if at all, and the impact of obtaining such preferential reimbursement treatment on BiDil sales, if any; the Company's ability to successfully market and sell BiDil; the effectiveness of the Company's marketing and sales strategy and efforts; the Company's ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to commercialize BiDil; unanticipated difficulties in maintaining regulatory approvals to market and sell BiDil; adverse side effects experienced by patients taking BiDil; the Company's ability to obtain or maintain intellectual property protection and required licenses; the Company's ability to obtain the substantial additional funding required to conduct manufacturing, marketing and sales of BiDil; unanticipated operating expenses for the remainder of the fiscal year 2006 and other factors discussed in the section titled "Risk Factors" in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, which has been filed with the SEC. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

For full prescribing information, visit: www.BiDil.com.

BiDil is a registered trademark of NitroMed, Inc.