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Lexington, MA December 23, 2004 NitroMed, Inc. (NASDAQ: NTMD) today completed the submission of the amendment to the new drug application (NDA) for BiDil® with the submission of the complete A-HeFT (African American Heart Failure Trial) study report. The results of A-HeFT demonstrated that African American patients with heart failure experienced a 43 percent improvement in survival, a 33 percent reduction in first hospitalization for heart failure and a significant improvement in overall quality of life after taking BiDil. These results, which occurred with BiDil added to other drug treatments, were presented at the American Heart Association’s Scientific Sessions in November 2004. “This completed submission marks a significant milestone for NitroMed,” said Manuel Worcel, M.D., Chief Medical Officer for NitroMed. “We look forward to working with the FDA to bring BiDil to the African American community, a population disproportionately burdened by heart failure and historically underrepresented in clinical trials.” In July 2004, the A-HeFT trial was halted early due to the significant survival benefit seen in patients on BiDil. As a result, NitroMed has accelerated its commercialization timeline and completed the recruitment of an experienced marketing and sales management team. “Our first priority lies in building a solid infrastructure in preparation for a potential BiDil launch in 2005,” said Mark Pavao, Senior Vice President, Sales and Marketing for NitroMed. “All NitroMed commercialization assets, including BiDil launch supplies and a fully trained, experienced sales force, will be in place by the end of Q1 2005, enabling us to focus our resources to effectively reach physicians caring for African Americans living with heart failure.” About BiDil As the lead product in development for NitroMed, BiDil is an orally-administered nitric oxide-enhancing drug candidate that was investigated in A-HeFT for its potential, when administered together with standard heart failure therapies, to reduce mortality and hospitalization and improve the quality of life of African Americans diagnosed with heart failure. BiDil is a combination of two drugs, isosorbide dinitrate and hydralazine. Isosorbide dinitrate is a nitric oxide donor. Hydralazine is an antioxidant and vasodilator, which means that it protects nitric oxide formed by isosorbide dinitrate and dilates blood vessels. Neither drug separately is indicated for heart failure. Because heart failure is a chronic disease, if approved, BiDil, like other medicines taken for chronic heart disease, will be taken for the duration of the patient's life. About NitroMed, Inc. NitroMed is an emerging pharmaceutical company focused on the research, development and commercialization of 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 new pharmaceuticals, 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 candidate, is an orally administered nitric oxide-enhancing medicine being developed for the treatment of heart failure in African Americans. Corporate collaborations are also an element of the Company's business strategy, and NitroMed has an agreement with Boston Scientific to jointly develop nitric oxide-enhanced cardiovascular stents. Forward Looking Statements Any statements in this press release about future expectations, plans and prospects for the Company, including statements regarding the Company's plans for the launch of BiDil in 2005, its financial forecasts, its ability to establish a sales force by the first quarter of 2005, as well as 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 develop or successfully contract for the sales, marketing and manufacturing competencies required to launch BiDil and any other product candidates for which it may receive regulatory approval; 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 September 30, 2004, 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. |
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