BiDil(R) Gains Broad Preferred Status on Pharmacy Benefit Plans
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NitroMed (NASDAQ: NTMD), said today that the reimbursement and formulary
status of BiDil continues to improve. To date, 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. The company defines ‘affordable’
as Tier 2 status, meaning out-of-pocket co-payments for patients are
approximately $25. BiDil®,
the fixed-dose combination of isosorbide dinitrate (ISDN) and
hydralazine hydrochloride (HYD), is approved by the FDA as adjunct
therapy in the treatment of heart failure in African Americans to
improve survival, reduce hospitalization and improve patient functional
status. Heart failure is a life threatening condition that
disproportionately burdens African Americans.
"BiDil enjoys preferred formulary status on
America’s four largest Medicare Part D drug
plans, and the two largest commercial drug plan providers,”
observed Gerald Bruce, NitroMed’s Senior Vice
President. "Additionally, BiDil is available
at tier 2 through the two largest pharmacy benefit management
formularies in the United States, and it is listed on the formularies of
numerous hospitals that provide heart failure care to large numbers of
African Americans. These strong coverage gains should once and for all
put to rest the perception that BiDil is out of reach and costly. In
fact, in many cases it is no more costly to patients than its untested
component agents ISDN and HYD which the FDA has said are not
bioequivalent to or substitutable for BiDil,”
he said. "Indeed, for the majority of
patients, the out-pocket cost for evidence-based BiDil is less or
comparable to the out-of-pocket cost of two prescription co-payments for
the untested component agents.”
The company said that the steady flow of clinical evidence supporting
BiDil’s efficacy, safety and its
cost-effectiveness are factors in the strong contracting activity.
The company will issue a statement at 9:00 AM today regarding a
published study on the use of BiDil's individual components that have
not been shown to be bioequivalent to the fixed dose combination.
About NitroMed, Inc.
NitroMed of Lexington, Massachusetts is an emerging pharmaceutical
company and the maker of BiDil®
(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 as an adjunct to current standard therapies such as
angiotensin converting enzyme (ACE) inhibitors and beta blockers. There
is little experience in patients with New York Heart Association Class
IV heart failure. 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 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.
