BiDilTreatment for Congestive Heart Failure
NitroMed Submits BiDil New Drug Application Amendment; Company Prepares for Commercialization of First Heart Failure Treatment for African Americans
LEXINGTON, Mass., 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."
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.
Posted: December 2004
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- FDA Advisory Committee Recommends Approval for NitroMed's BiDil to Treat Black Patients With Heart Failure - June 16, 2005
- Organizations Unite to Support BiDil's Approval for Heart Failure, Rebuff Designation as 'Race-Only' Drug - June 15, 2005
- FDA Schedules Advisory Committee Review of BiDil - April 29, 2005
- FDA Accepts NitroMed's New Drug Application Resubmission for BiDil; Submission Granted a June 23, 2005 PDUFA Date - February 3, 2005