PROACTION Study Designed to Quantify Economic Benefits of Natrecor
In Treating Acute Congestive Heart Failure
SUNNYVALE, Calif., March 19 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
today announced the initiation of a new study aimed at investigating the
potential pharmacoeconomic impact of its lead drug candidate, Natrecor(R)
(nesiritide), in improving treatment and outcomes for acute congestive heart
failure patients. Acute congestive heart failure (CHF) is a fast-growing
disorder that causes one million hospitalizations and costs the healthcare
system about $23 billion each year.
PROACTION (Prospective Randomized Outcomes Study of Acutely Decompensated
Congestive Heart Failure Treated Initially in Outpatients with Natrecor) is a
pilot study designed to compare the clinical effects, safety profile and
economic impact of standard therapy plus Natrecor to standard therapy plus
placebo in 250 acute CHF patients treated in the Emergency Department
(ED)/Observation Unit (OU). The majority of the one million hospitalizations
each year for this indication begin in either the ED or the OU. Standard
therapy will consist of any treatments physicians would typically use for
these patients. Scios expects to complete this study in the third quarter
of 2001.
"This study is designed to look at numerous measures that factor in the
overall cost of hospitalization for patients with acute CHF," said
Charles L. Emerman, M.D., Chairman, Department of Emergency Medicine, The
Cleveland Clinic Foundation and MetroHealth Medical Center. "We will examine
admission to the hospital following evaluation and treatment in the ED/OU, and
other pharmacoeconomic measures. We believe Natrecor's fixed-dose
administration compared to the titration schedule and safety profile of
existing therapies may result in a lower overall cost of care for patients
hospitalized with acute CHF."
On January 10, 2001, Scios submitted an amendment to its New Drug
Application for Natrecor to the U.S. Food and Drug Administration, requesting
approval to market Natrecor for the treatment of acute CHF.
The amendment was based largely on the results of the VMAC (Vasodilation
in the Management of Acute Congestive heart failure) trial, which demonstrated
that Natrecor, added to standard care, had a statistically significant effect
on the primary endpoint, reducing pulmonary capillary wedge pressure (PCWP, or
filling pressures) in as little as 15 minutes. The hemodynamic effect of
reducing filling pressures was sustained for at least 48 hours. At three
hours, Natrecor plus standard care significantly improved PCWP, compared to
either the placebo plus standard care or IV nitroglycerin plus standard care
regimens tested, and significantly improved patient breathing compared to the
placebo plus standard care regimen. Natrecor also produced a more rapid
improvement in patient hemodynamics, and caused significantly fewer side
effects than the IV nitroglycerin regimen.
In the first three hours of the VMAC trial, 5% of the Natrecor patients
reported headache, vs. 12% for nitroglycerin. In the first 24 hours of the
trial, 9% of the Natrecor patients reported headache, vs. 20% for
nitroglycerin. Symptomatic hypotension was reported in 4% of the Natrecor
patients and 5% of the nitroglycerin patients.
Natrecor
Natrecor is a recombinant form of B-type natriuretic peptide (BNP), a
naturally occurring hormone in the body that aids healthy functioning of the
heart. BNP is secreted by the ventricles of the heart as one of the body's
natural responses to heart failure. When the heart is unable to pump blood
efficiently, BNP is produced to ease its workload. BNP appears to relax blood
vessels (vasodilation), increase the excretion of sodium (natriuresis) and
fluid (diuresis), and decrease neurohormones that lead to vessel constriction,
fluid retention and elevated blood pressure.
Scios Inc.
Scios is a biopharmaceutical company developing novel treatments for heart
failure and rheumatoid arthritis. The company's disease-based technology
platform integrates expertise in protein biology with combinatorial and
medicinal chemistry to identify novel targets and rationally design small
molecule compounds to treat cardiovascular and inflammatory diseases, two of
the world's leading unmet medical needs. Additional information on Scios is
available at its web site located at http://www.sciosinc.com and in the company's
various filings with the Securities and Exchange Commission.
The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties. These
include uncertainties associated with anticipating the response of the FDA to
the results of the VMAC trial, the timing of regulatory approval of Natrecor,
the timing and results of the PROACTION study, and acceptance by the medical
community of Natrecor as a new therapy for acute decompensated CHF, as well as
other risks detailed from time to time in the reports filed by Scios with the
SEC, including the company's annual report on form 10-K for the year ended
December 31, 1999 and subsequent reports on form 10-Q.
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
Wendy Carhart of Scios Inc., 408-616-8325; or
Jim Weiss of Weisscomm, 415-203-0328, for Scios Inc.; or Don
Hyman of Edelman Public Relations, 212-642 7741, for Scios Inc.
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