LEXINGTON, Mass.--(BUSINESS WIRE)--Sept. 24, 2007--A study
published in the current edition of Clinical Pharmacokinetics, a
peer-reviewed scientific journal, reports that two different
combinations of individual isosorbide dinitrate (ISDN) and hydralazine
hydrochloride (HYD), used in the Vasodilator-Heart Failure Trials
(V-HeFT) I and II are not bioequivalent to BiDil(R), the fixed-dose
combination of ISDN and HYD, used in the African American Heart
Failure Trial (A-HeFT). The study compared identical amounts of the
formulations of ISDN and HYD used in V-HeFT I and II, and BiDil, the
proprietary fixed dose combination, used in A-HeFT and demonstrated
that the formulations used in V-HeFT I and V-HeFT II are neither
bioequivalent to each other, nor to BiDil.
Generic formulations of ISDN and HYD have not been shown to be
bioequivalent to BiDil and there is no basis to conclude that the
clinical efficacy of generic ISDN and hydralazine will be the same as
BiDil. Only BiDil was studied and proven effective in A-HeFT and it is
unknown whether other formulations provide the same clinical benefits.
The non-bioequivalence in the formulations used may explain why V-HeFT
I, V-HeFT II, and A-HeFT had very different results in reducing
mortality and morbidity. BiDil is an orally administered medicine
approved in the United States for the treatment of heart failure in
self-identified black patients.
"Decreasing mortality is really important and BiDil does that.
Currently available formulations of ISDN and HYD have not been shown
to have the same mortality and morbidity benefit as BiDil or to be
therapeutically equivalent to or substitutable for BiDil. Heart
failure in blacks carries a mortality rate higher than many forms of
cancer, as well as impairing quality of life and requiring acute
hospital admissions. In treating this life- threatening disease, it's
now clear that the use of BiDil represents standard of care for these
patients," said Dr. Milton Packer, a heart failure specialist and
co-author of the study from the University of Texas, Southwestern
Medical Center in Dallas.
Earlier today, NitroMed reported that 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.
About NitroMed, Inc.
NitroMed of Lexington, Massachusetts is an emerging pharmaceutical
company and the maker of BiDil(R) (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 for the
treatment of heart failure as an adjunct to current standard therapy,
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
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)/Revatio(TM), Levitra(R), Cialis(R)) could result in severe
hypotension. Adverse events reported in A-HeFT and seen more
frequently in the group given BiDil included headache (50% in BiDil
patients vs. 21% in placebo patients) and dizziness (32% in BiDil
patients vs. 14% in placebo patients).
BiDil is marketed by NitroMed through a specialty medicines sales
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
CONTACT: NitroMed, Inc.
Jane A. Kramer, 781-266-4220
SOURCE: NitroMed, Inc.