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Published Study: Use of BiDil(R) Individual Components Are Not Bioequivalent to the Fixed Dose Combination BiDil- Used in A-HeFT

LEXINGTON, Mass.--(BUSINESS WIRE)--Sept. 24, 2007--A study published in the current edition of Clinical Pharmacokinetics, a peer-reviewed scientific journal, reports that two different combinations of individual isosorbide dinitrate (ISDN) and hydralazine hydrochloride (HYD), used in the Vasodilator-Heart Failure Trials (V-HeFT) I and II are not bioequivalent to BiDil(R), the fixed-dose combination of ISDN and HYD, used in the African American Heart Failure Trial (A-HeFT). The study compared identical amounts of the formulations of ISDN and HYD used in V-HeFT I and II, and BiDil, the proprietary fixed dose combination, used in A-HeFT and demonstrated that the formulations used in V-HeFT I and V-HeFT II are neither bioequivalent to each other, nor to BiDil.

Generic formulations of ISDN and HYD have not been shown to be bioequivalent to BiDil and there is no basis to conclude that the clinical efficacy of generic ISDN and hydralazine will be the same as BiDil. Only BiDil was studied and proven effective in A-HeFT and it is unknown whether other formulations provide the same clinical benefits. The non-bioequivalence in the formulations used may explain why V-HeFT I, V-HeFT II, and A-HeFT had very different results in reducing mortality and morbidity. BiDil is an orally administered medicine approved in the United States for the treatment of heart failure in self-identified black patients.

"Decreasing mortality is really important and BiDil does that. Currently available formulations of ISDN and HYD have not been shown to have the same mortality and morbidity benefit as BiDil or to be therapeutically equivalent to or substitutable for BiDil. Heart failure in blacks carries a mortality rate higher than many forms of cancer, as well as impairing quality of life and requiring acute hospital admissions. In treating this life- threatening disease, it's now clear that the use of BiDil represents standard of care for these patients," said Dr. Milton Packer, a heart failure specialist and co-author of the study from the University of Texas, Southwestern Medical Center in Dallas.

Earlier today, NitroMed reported that approximately 80% of African Americans who have commercial and Medicare Part D and Medicaid prescription drug insurance coverage in the United States, have affordable access to BiDil.

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 available in the United States for the treatment of heart failure in self-identified black patients. In this population, BiDil is indicated for the treatment of heart failure as an adjunct to current standard therapy, 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 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. Adverse events reported in A-HeFT and seen more frequently in the group given BiDil included headache (50% in BiDil patients vs. 21% in placebo patients) and dizziness (32% in BiDil patients vs. 14% in placebo patients).

BiDil is marketed by NitroMed through a specialty medicines sales organization.

For full prescribing information, visit: www.BiDil.com. BiDil is a registered trademark of NitroMed, Inc.

Forward Looking Statements

Statements in this press release about future expectations, plans and prospects for the Company, including the Company's positioning to achieve the Company's goals and objectives, 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 discussed in the Section titled "Risk Factors" in the Company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2007, which has been filed with the SEC, and in the other filings that the Company makes with the SEC from time to time. 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.

CONTACT: NitroMed, Inc.
Jane A. Kramer, 781-266-4220
C: 781-640-8499

SOURCE: NitroMed, Inc.

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