SUNNYVALE, Calif., March 26 /PRNewswire-FirstCall/ --
Scios, Inc. (Nasdaq: SCIO) today announced that the lead article and editorial
published in this week's issue of the Journal of the American Medical
Association (JAMA) support the use of the company's flagship product,
Natrecor(R) (nesiritide), for the treatment of acutely decompensated
congestive heart failure in patients with shortness of breath at rest or with
minimal activity.
"This publication reinforces our belief that Natrecor is an ideal initial
agent for physicians to use along with diuretics before considering
conventional treatment options," said Darlene P. Horton, M.D., Vice President
of Medical Affairs at Scios. "The clinical community has indicated they are
enthusiastic about using Natrecor as part of a new treatment paradigm for
acute heart failure."
The lead article reported the results of the VMAC (Vasodilation in the
Management of Acute Congestive Heart Failure) study, a randomized double-blind
trial involving 489 patients with acute heart failure treated at 55 hospitals
between October 1999 and July 2000. These patients were assigned to one of
four treatment groups. They received either a fixed or adjustable dose of
intravenous Natrecor, intravenous nitroglycerin or placebo plus standard care.
The investigators tracked changes in dyspnea, or shortness of breath, and
pulmonary capillary wedge pressure (PCWP). PCWP estimates the heart's
internal filling pressure and is a standard measure of cardiac function in
patients with acute heart failure.
The improvement (reduction) in PCWP was significantly greater in the
Natrecor group than in the nitroglycerin or placebo groups, starting with the
first measurement at 15 minutes. Sixty percent of the three-hour reduction in
PCWP was observed at 15 minutes and 95 percent of the three-hour reduction in
PCWP was seen in the first hour. At three hours, the effect of Natrecor on
PCWP was statistically significantly greater than both nitroglycerin and
placebo while the effect of nitroglycerin was similar to placebo. At 24 hours
the mean reduction in PCWP was significantly greater with Natrecor than
nitroglycerin (placebo patients had crossed over to active therapy after three
hours).
Patients who received Natrecor also reported feeling less breathless at
three hours compared to placebo plus standard care whereas the effect of
nitroglycerin was similar to placebo. There were no significant differences
in the frequency of serious adverse events through 30 days for either
treatment group.
"The findings reported in this publication suggest that Natrecor should be
used as a first-line treatment for acutely decompensated CHF," said lead
author James B. Young, M.D., medical director of the Kaufman Center for Heart
Failure at The Cleveland Clinic and head of the Section of Heart Failure at
The Cleveland Clinic Heart Center.
About Natrecor
Scios received approval for Natrecor from the U.S. Food and Drug
Administration (FDA) in August 2001 for the treatment of acutely decompensated
heart failure in patients with dyspnea at rest or with minimal activity.
Administered intravenously, Natrecor is a recombinant form of human B-type
natriuretic peptide (hBNP), a naturally occurring hormone in the body that
promotes healthy functioning of the heart.
Natrecor may cause hypotension. If hypotension occurs during
administration of Natrecor, the dose should be reduced or discontinued, and
blood pressure should be monitored closely. At the recommended dose of
Natrecor, the incidence of symptomatic hypotension (4%) was similar to that of
IV nitroglycerin (5%). Asymptomatic hypotension occurred in 8% of patients
treated with both drugs. The mean duration of symptomatic hypotension was
longer with Natrecor than IV nitroglycerin (2.2 versus 0.7 hours,
respectively). Natrecor may affect renal function in susceptible patients. In
the 30-day follow-up period in the VMAC (Vasodilation in the Management of
Acute Congestive Heart Failure) trial, 5 patients in the IV nitroglycerin
group (2%) and 9 patients in the Natrecor group (3%) required first-time
dialysis. Other adverse events reported at a rate of at least 5% during the
first 24 hours of infusion with either Natrecor plus standard care or IV
nitroglycerin plus standard care therapy, included, respectively: ventricular
tachycardia (3%, 5%), nonsustained ventricular tachycardia (3%, 5%), headache
(8%, 20%), abdominal pain (1%, 5%), and nausea (4%, 6%). Higher doses of
Natrecor increased the risk of hypotension and elevated creatinine. Natrecor
should be avoided in patients with cardiogenic shock, systolic blood pressure
<90 mm Hg, or in patients with low cardiac filling pressures. Please refer to
http://www.natrecor.com for full Prescribing Information.
About Scios Inc.
Scios is a biopharmaceutical company developing novel treatments for
cardiovascular and inflammatory disease. 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 for large markets with unmet medical needs.
Forward-Looking Safe Harbor Statement
This news release contains forward-looking statements within the meaning
of Section 27A of the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. We generally identify such forward-looking statements
using words like "believe," "intend," "expect," "may," "should," "plan,"
"project," "contemplate," "anticipate" or similar statements. Statements that
are not historical facts are forward-looking statements based on current
assumptions that involve risks and uncertainties. These risks and
uncertainties may include the sales penetration and success of Natrecor, the
success of clinical trials of Natrecor and our pipeline products, including
SCIO-469 and our inhibitors of the TGF-beta receptor, as well as other risks
detailed from time to time in the reports filed by Scios with the SEC,
including the Company's quarterly reports and annual report on Form 10-K.
Actual results, performance or achievements of Scios may differ significantly
from those described in these forward-looking statements. Scios disclaims any
intention or obligation to update or revise any financial projections or
forward-looking statements, whether as a result of new information, future
events or otherwise.
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
David Gryska of Scios Inc., +1-408-616-8303;
or, media, Jim Weiss of WeissCom Partners, Inc., +1-415-203-0328,
or, investors, Fern Lazar of Lazar Partners, +1-212-867-1765,
both for Scios Inc.
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