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COMMUNITY SUPPORT
NAACP and NitroMed Announce Partnership to Narrow Disparities in Cardiovascular Healthcare; Press Conference Today at 9:30 am ET BALTIMORE and LEXINGTON, Mass., Dec 14, 2005 (BUSINESS WIRE) -- The National Association for the Advancement of Colored People (NAACP) and NitroMed, Inc. (NASDAQ:NTMD) today announced a strategic alliance to implement measures to narrow health care disparities that exist between African Americans and Caucasians in areas of access, affordability, quality, infrastructure and compliance. As part of the partnership, NitroMed is providing a three-year $1.5 million grant to establish an organizational infrastructure to allow the NAACP to develop health advocacy initiatives towards equal access to quality healthcare. Bruce S. Gordon, NAACP President and CEO, said, "The NAACP is proud to partner with NitroMed and is committed to assisting at the grass root and legislative levels. The availability of new life-saving treatments such as BiDil, supported by NitroMed's innovative program to make the drug accessible, is consistent with our guiding principle that affordable health services without bureaucratic and financial barriers should be considered a fundamental societal obligation." The NAACP intends to roll out programs that include: increasing visibility and awareness in the black community; developing an Advocacy Action Plan with the NAACP National Health Leadership Committee; implementing a two day training with the seven regional health care representatives of the NAACP Health Advocacy Department; rolling out the Plan for the top tier state and local NAACP chapters and during the 2006 National Leadership Summit; and developing a consensus paper on the state of African American health care and the impact of Medicare. NitroMed is the maker of BiDil(R) (isosorbide dinatrate/ hydralazine HCl), a prescription medicine approved this year by the Food and Drug Administration (FDA) for the treatment of heart failure in black patients as an adjunct to other standard therapies. Earlier this year, the NAACP issued an Emergency Resolution encouraging black patients to discuss BiDil and other treatments with their doctors. Dr. Michael Loberg, NitroMed Chief Executive Officer, said, "Because the FDA's approval of BiDil is specifically for the treatment of black heart failure patients, it is our responsibility to put real resources toward policies and programs that address health care disparities. At the same time, together with the NAACP, we are doing our part to remove all barriers to access of BiDil." Given the pending implementation of the Medicare Modernization Act, the NAACP, along with NitroMed, the National Institute of Health and other partners, is embarking on a significant effort to assist with patient enrollment in Medicare Part D. The NAACP and NitroMed partnership includes an initiative to inform Medicare beneficiaries about prescription medicine coverage options, which become available January 1, 2006 and to encourage people to enroll early. The deadline to be eligible by January 1 is December 31, 2005. Medicare beneficiaries are eligible for drug coverage regardless of income or health status. Enrollees may choose from an array of plans relative to types of medicines patients need and pharmacies included as well as co-pays and deductibles required. With its commercial launch this summer, NitroMed introduced NitroMed Cares(TM), a patient assistance program that helps to make BiDil accessible to all patients who need it, regardless of income level or health insurance status. Through the program, NitroMed provides BiDil free of charge to heart failure patients who have no health coverage and whose annual incomes are up to three times the poverty level according to Federal guidelines. Founded in 1909, the National Association for the Advancement of Colored People is the nation's oldest and largest civil rights organization. Its half-million adult and youth members throughout the United States and the world are the premier advocates for civil rights in their communities and monitor equal opportunity in the public and private sectors. Press Conference Details A press conference will be held this morning at 9:30 am ET to introduce and discuss the alliance. Representatives from the NAACP and NitroMed will speak, as well as key policy makers and physician experts in cardiovascular care. Media should dial (800) 659-1966 and use passcode 20325117. All other participants (listen-only) can dial (866) 510-0711 and use passcode 18868577. Participants can also access the press conference by a webcast link on the following websites: www.nitromed.com or www.naacp.org. 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. Heart Failure Burden in Black Patients Heart failure, or end-stage cardiovascular disease, 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) /RevatioT, 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. NitroMed 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 NitroMed, including statements regarding NitroMed's expectations from its strategic alliance with the NAACP, the benefits of BiDil, and its plans to make BiDil available to patients who can gain from its therapeutic benefits, 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: patient, physician and third-party payer acceptance of BiDil as a safe and effective therapeutic; maintaining existing regulatory approvals to market and sell BiDil; NitroMed's ability to develop and maintain the necessary sales, marketing and manufacturing capabilities to launch and commercialize BiDil; adverse side effects experienced by patients taking BiDil; NitroMed's ability to obtain or maintain intellectual property protection and required licenses; NitroMed'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 NitroMed's views as of the date of this release. NitroMed anticipates that subsequent events and developments will cause NitroMed's views to change. However, while NitroMed may elect to update these forward-looking statements at some point in the future, NitroMed specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing NitroMed'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. For more information on NitroMed, visit: www.nitromed.com. SOURCE: NitroMed, Inc. NAACP Office of Communications |
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