< 2004 News Listings American Heart Association Adds A-HeFT Heart Failure Study To Late-Breaking Plenary Session Phase III Clinical Data on Heart Failure Drug BiDil® will be Presented at November Annual Meeting LEXINGTON, MS September 16, 2004 NitroMed, Inc. (NASDAQ:NTMD) announced today that the American Heart Association has disclosed that the Phase III African American Heart Failure (A-HeFT) clinical trial data will be presented by Anne L. Taylor, M.D., Chairperson of the A-HeFT Steering Committee, at a late-breaking session during its annual meeting, November 7-10 in New Orleans, La. The plenary session presentation will be held on Monday, November 8th, 11:45 a.m. - 12:00 p.m. This follows on the recent recommendations of the (A-HeFT) Data Safety and Monitoring Board (DSMB) and Steering Committees to halt the confirmatory Phase III clinical trial of BiDil® due to the significant survival benefit seen with the drug. BiDil is NitroMed's orally administered nitric-oxide enhancing drug which combines isosorbide dinitrate and hydralazine. Over 1,000 African American patients in 170 sites across the United States were enrolled in A-HeFT, a double blind placebo controlled trial. About NitroMed, Inc. NitroMed is an emerging pharmaceutical company that discovers, develops and seeks to commercialize proprietary pharmaceuticals based on the therapeutic benefits of the naturally occurring molecule nitric oxide. The Company uses its expertise in nitric oxide biology and chemistry in an effort to develop both novel drugs, as well as safer, more effective versions of existing drugs. Research and development efforts focus on major diseases that are characterized by a deficiency in nitric oxide, such as cardiovascular and inflammatory diseases. BiDil®, the Company's lead product in development, is an orally administered nitric oxide-enhancing medicine being investigated for the treatment of heart failure in African Americans. Because of the significant survival benefit seen with BiDil, NitroMed halted its confirmatory Phase III clinical trial of the drug. The action was taken on July 19, 2004 and followed the unanimous recommendations of both the trial's independent Data and Safety Monitoring Board (DSMB) and its Steering Committee. Over 1,000 patients in 170 sites across the United States were enrolled in the double blind placebo controlled trial, known as the African American Heart Failure Trial (A-HeFT). The Association of Black Cardiologists is a joint sponsor of the study. Collaborative partnerships are a key element of the Company's business strategy. NitroMed has agreements with Merck to jointly develop nitric oxide COX-2 inhibitors and with Boston Scientific to jointly develop nitric oxide coated cardiovascular stents. Forward Looking Statements Any statements in this press release about future expectations, plans and prospects for the Company, including statements containing the words "believe," "anticipate," "plan," "expect," "will," "may," and similar expressions, 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: difficulties or delays relating to required regulatory approvals to develop, market and sell BiDil and the Company's other products under development; the Company's ability to successfully complete clinical trials of its products under development; the Company's dependence on corporate collaborators to develop, manufacture, market and sell products based upon its technologies; the Company's failure to obtain or maintain intellectual property protection and required licenses for its technologies and products under development; the Company's ability to obtain the substantial additional funding required to conduct research and development, manufacturing, marketing and sales of its products under development; and other factors discussed in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2004, 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. CONTACT: NitroMed, Inc. Lawrence E. Bloch, 781-266-4197 SOURCE: NitroMed, Inc.
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