FREMONT, Calif., Aug. 22 /PRNewswire/ -- Scios Inc. today announced it is
launching a comprehensive recommended use initiative for NATRECOR(R)
(nesiritide), its treatment for acutely decompensated heart failure (ADHF).
The intent of the initiative is to educate healthcare providers regarding
those patients who should receive NATRECOR(R) and those for whom Scios does
not recommend the use of NATRECOR(R) based on currently available clinical
data.
The recommended use initiative is a direct response to recommendations the
company recently sought from a panel of leading U.S. cardiologists. The full
panel report can be found at http://www.natrecor.com. All company activities related
to NATRECOR(R) will be focused on use in patients with ADHF presenting to the
hospital with shortness of breath -- or dyspnea -- at rest or with minimal
activity (such as talking, eating or bathing).
"We are committed to our recommended use initiative and we are confident
that it will further assist healthcare professionals in identifying
appropriate patients for treatment with NATRECOR(R)," said Darlene Horton,
M.D., senior vice president of clinical research and medical affairs at Scios.
"NATRECOR(R) continues to be an important therapy for patients presenting to
the hospital with ADHF. These patients have few well-studied treatment
options."
The NATRECOR(R) recommended use initiative will be rolled out over the
next several weeks and will consist of a number of activities, including:
-- Training the entire sales force and all promotional speakers
regarding the recommended use of NATRECOR(R),
-- The creation of new promotional materials for use with healthcare
providers,
-- Including recommended use language in promotional speakers programs,
and
-- Advertising in top-tier medical journals.
To date, the company has disseminated a letter to more than 160,000
healthcare professionals describing those patients for whom NATRECOR(R)
therapy is appropriate, incorporated the recommended use information into the
toll-free NATRECOR(R) support line and trained external speakers on the
recommended use of NATRECOR(R).
In May of 2005, Scios asked Dr. Eugene Braunwald, Distinguished Hersey
Professor of Medicine, Harvard Medical School, and Chairman TIMI Study Group
at Brigham and Women's Hospital in Boston, to identify and convene a panel of
leading cardiologists to review and assess important data associated with
NATRECOR(R), to provide guidance and counsel on the ongoing and planned
clinical development program and to provide recommendations with regard to use
of the product. The panel met on June 8th and, shortly thereafter, issued
recommendations to the company that included an educational program related to
the appropriate use of NATRECOR(R).
"We asked the panel to provide us with guidance regarding NATRECOR(R), and
we have shared and discussed our planned response to these recommendations
with panel members," said Dr. Horton. "With regard to the use of NATRECOR(R),
there are some modest differences between the panel's specific recommendations
and Scios' recommended use initiative. However, we believe that this
comprehensive effort enhances our focus on advocating the use of NATRECOR(R)
in a patient population that is consistent with the population studied in the
trials that led to the approval of the drug."
NATRECOR(R) remains the only therapy approved for the treatment of ADHF
that has a demonstrated clinical benefit, specifically the improvement of
severe breathing difficulties leading to hospitalization. More information is
known about NATRECOR(R) -- based on large, well-controlled clinical trials --
than exists for any other intravenous therapy approved for ADHF.
"We are committed to studying NATRECOR(R) to further demonstrate its value
for these very sick patients," added Dr. Horton. "Consistent with the panel's
recommendations, we are proceeding with our clinical development program
through FUSION II and other studies to better understand how this medicine can
benefit patients with this debilitating condition."
Scios Inc., a Johnson & Johnson company, is a biopharmaceutical company
headquartered in Fremont, California. Scios is developing novel treatments
for cardiovascular disease, inflammatory disease and cancer. The Company's
disease-based technology platform integrates expertise in protein biology with
computational and medicinal chemistry to identify novel targets and rationally
design small molecule compounds and peptides for markets with unmet medical
needs. For more information, visit http://www.sciosinc.com.
IMPORTANT SAFETY INFORMATION
HYPOTENSION
NATRECOR(R) (nesiritide) may cause hypotension and should be administered
only in settings where blood pressure can be monitored closely. If
hypotension occurs during administration of NATRECOR(R), the dose should be
reduced or discontinued. At the recommended dose of NATRECOR(R), the incidence
of symptomatic hypotension (4%) was similar to that of IV nitroglycerin (5%).
Asymptomatic hypotension occurred in 8% of patients treated with either drug.
In some cases, hypotension that occurs with NATRECOR(R) may be prolonged. The
mean duration of symptomatic hypotension was longer with NATRECOR(R) than IV
nitroglycerin (2.2 versus 0.7 hours, respectively). NATRECOR(R) should not be
used in patients with systolic blood pressure <90 mm Hg or as primary therapy
in patients with cardiogenic shock. The rate of hypotension may be increased
with higher doses of NATRECOR(R) or in patients with baseline blood pressure
<100 mm Hg, and NATRECOR(R) should be used cautiously in these patients.
NATRECOR(R) is not recommended for patients for whom vasodilating agents
are not appropriate and should be avoided in patients with low cardiac filling
pressures.
RENAL
NATRECOR(R) may affect renal function in susceptible individuals. In
patients with severe heart failure whose renal function may depend on the
activity of the renin-angiotensin-aldosterone system, treatment with
NATRECOR(R) may be associated with azotemia. In the VMAC trial, through day
30, the incidence of elevations in creatinine to > 0.5 mg/dL above baseline
was 28% and 21% in the NATRECOR(R) and nitroglycerin groups, respectively.
When NATRECOR(R) was initiated at doses higher than 0.01 mcg/kg/min, there was
an increased rate of elevated serum creatinine over baseline compared with
standard therapies, although the rate of acute renal failure and need for
dialysis was not increased.
MORTALITY
In seven NATRECOR(R) clinical trials, at 30 days, 5.3% in the NATRECOR(R)
treatment group died as compared with 4.3% in the group treated with other
standard medications. In four clinical trials, at 180 days, 21.7% in the
NATRECOR(R) treatment group died as compared with 21.5% in the group treated
with other medications. There is not enough information to know if there is an
increased risk of death after treatment with NATRECOR(R).
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Mark T. Wolfe of Scios, +1-908-927-2745, or
cell, +1-908-672-4988
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