Data Show Cost-Effectiveness of NitroMed's BiDil(R) Through Reduced Hospitalization, Cost of Care in Black Patients; Analysis Published Today in Circulation: Journal of the American Heart Association.

LEXINGTON, Mass. -- According to a pharmacoeconomic analysis titled "Cost-Effectiveness of Fixed-Dose Combination of Isosorbide Dinitrate and Hydralazine Therapy for Blacks with Heart Failure" published today in Circulation: Journal of the American Heart Association, BiDil(R) (isosorbide dinitrate/hydralazine hydrochloride) is a cost-effective way to treat heart failure in self-identified black patients. Study results indicate that treatment with BiDil in the African American Heart Failure Trial (A-HeFT) reduced heart failure-related and all healthcare resource use and costs, due primarily to substantial reductions in both number and length of heart failure-related hospitalizations.

NitroMed's (NASDAQ: NTMD) BiDil was approved in June 2005 by the U.S. Food and Drug Administration (FDA) and is indicated to improve survival, prolong time to hospitalization for heart failure and improve patient-reported functional status in self-identified black patients when used as an adjunct to current standard therapy.

"Our analysis shows that use of BiDil during the time interval of the A-HeFT trial resulted in substantial cost savings to the healthcare system. This is an important advantage that extends beyond the significant clinical benefit observed with BiDil," said study co-author, Jalal K. Ghali, M.D., Louisiana State University Health Sciences Center, Shreveport, La. "A-HeFT followed patients for an average of just over one year before the trial was halted due to the strong survival benefit observed in BiDil-treated patients. While the pharmacoeconomic analysis demonstrates BiDil's cost-savings during the trial period, our economic model also suggests long-term use of BiDil will be cost-effective."

Including the cost of BiDil at the current retail price, use of BiDil versus placebo in A-HeFT during the average 12.8 month follow-up resulted in per patient savings of $533 for heart failure-related costs and savings of $1,730 for total direct healthcare costs. Data gathered during A-HeFT indicate the following for patients taking BiDil:

--30 percent reduction in heart failure-related hospitalizations

--41 percent reduction in the length of hospital stay

--Six percent decrease in heart failure-related costs (including the cost of BiDil)

--Nine percent decrease in total healthcare costs (including the cost of BiDil)

The analysis also projected the cost per life-years saved by comparing the cost of BiDil based on the duration of time the therapy prolonged life on average to the overall cost of treatment for heart failure patients not taking the drug. In the U.S., if a drug therapy extends life by a year at a cost of under $50,000, it is generally considered by health economists to be cost-effective.

Assuming no additional benefits accrue beyond the trial, the study projects the cost-effectiveness of BiDil using heart failure-related costs to be $16,600 per life-year at two years post enrollment, $37,100 per life-year at five years, and $41,800 per life-year over lifetime, meaning that BiDil would remain cost-effective over the long-term.

"Despite advances in care, heart failure remains a major health concern, shortening survival, impairing quality of life and requiring frequent hospitalizations," said Michael D. Loberg, Ph.D., President and Chief Executive Officer, NitroMed. "There is a major cost burden in treating heart failure in the United States - it is the top Medicare DRG - so we are very pleased that BiDil represents not only an important medical advance for patients, but also a way to reach near-term cost savings and reduce long-term cost burden."

Approximately five million Americans currently have heart failure, with 550,000 new cases diagnosed each year. Costs to treat the disease are staggering and are estimated at $28 billion in 2005.(1) This figure includes inpatient care - with associated physician and professional fees, laboratory charges and pharmacy costs - plus outpatient care.

In A-HeFT, 1,050 self-identified black patients with New York Heart Association (NYHA) class III or IV heart failure were randomized at 169 sites nationwide to receive either BiDil or placebo, in addition to current standard heart failure therapy. The cost-effectiveness data were collected during the mean trial follow-up of 12.8 months.

Hospitalization information was collected during monthly phone interviews and study visits, including a review of medical records to determine the reason for hospital admission. A Medicare-based cost-estimate system was established to determine hospitalization and length of stay costs, while the $1.80 cost of BiDil and the average prescription dose was used to account for the treatment cost.

Long-term costs per years of life saved were generated based on lifetime estimates of costs and effects as per the U.S. Public Health Service Panel on Cost-Effectiveness in Health and Medicine (PCEHM), with costs expressed in 2004 costs and increasing at a rate of three percent each year.

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.

BiDil treatment is orally-administered and is initiated at a dose of one tablet, three times per day, and may be increased to a maximum of two tablets, three times per day, based on patient tolerance. Adjustments to maximum dosage may occur in three to five days; however, adverse side effects, which may include headaches and dizziness, may require that some patients take more time to reach their highest tolerated dose.

Heart Failure Burden in Black Patients

Heart failure 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 a research-based 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, and is marketed by NitroMed through a nationwide, dedicated sales force.

The Company is committed to the development of novel pharmaceuticals and safer, more effective versions of existing drugs to treat underserved patient populations. NitroMed's development efforts are primarily directed at expanding its cardiovascular franchise.

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 long-term cost effectiveness of BiDil for the treatment of heart failure in self-identified black patients, 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: unanticipated difficulties in maintaining regulatory approvals to market and sell BiDil; the Company's ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to launch and commercialize BiDil; patient, physician and third-payer acceptance of BiDil as a safe and effective therapeutic with near term cost-savings and long term cost-effectiveness benefits; 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 and other factors discussed in its Quarterly Report on Form 10-Q for the Quarter ended September 30, 2005, which is 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.

(1)American Heart Association. Heart Disease and Stroke Statistics - 2005 Update. Source: American Heart Association Web site