Studies Involving Over 1,700 Patients Demonstrate Natrecor Rapidly Improves
Blood Circulation, Relieves Patient Symptoms
SUNNYVALE, Calif., March 20 /PRNewswire/ -- Scios, Inc. (Nasdaq: SCIO)
announced today that a comprehensive review article published in this week's
issue of the Journal of Cardiac Failure concludes that its investigational new
drug, Natrecor(R) (nesiritide), could become a valuable addition to the
treatment of acute congestive heart failure (CHF).
The article reviews results of clinical trials involving more than
1,700 patients and concludes that Natrecor rapidly improves blood circulation
and alleviates symptoms associated with acute CHF, such as shortness of breath
and fatigue. 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. It causes arteries and veins to dilate, alleviating symptoms by
improving blood movement around the heart without a change in heart rate.
Natrecor is administered intravenously in a standard fixed dose regimen, and
does not require titration (i.e., dose adjustments).
"The impressive amount of data collected, analyzed and presented to date
indicate that nesiritide improves symptoms, is well-tolerated and would be a
valuable addition to the initial treatment of patients admitted to the
hospital for acute decompensated CHF," said the article's author, Wilson S.
Colucci, M.D., Professor of Medicine and Physiology and Cardiovascular
Medicine, Boston University School of Medicine. "The drug's salutary clinical
and hemodynamic profile, rapid onset of action, ease of administration and
favorable safety profile circumvent several of the limitations we have with
currently available treatments."
The article examines several studies, including the recently completed
498-patient 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), a measure of the pulmonary congestion
resulting from acute CHF, in as little as 15 minutes. This effect 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 intravenous (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.
Another recent study discussed in the article is the PRECEDENT
(Prospective Randomized Evaluation of Cardiac Ectopy with Dobutamine or
Nesiritide Therapy) trial, which showed that Natrecor produced fewer
arrhythmias (irregular heart beats) and improved overall mortality rates
compared to dobutamine, a commonly administered inotropic agent. The other
studies reviewed in the article were published in the July 27th issue of The
New England Journal of Medicine. In those studies, infusion of Natrecor in
acute CHF patients resulted in significant improvements in hemodynamic
function (i.e., blood circulation forces), including an increase in the
cardiac index, and rapid and sustained improvements in clinical status.
Earlier this year, Scios submitted an amendment to its existing New Drug
Application (NDA) for Natrecor to the U.S. Food and Drug Administration based
largely on the VMAC and PRECEDENT data. If approved, Natrecor would be the
first new treatment for acute CHF in more than a decade.
"We are working closely with the agency and believe we have provided them
with the evidence necessary for approval," said Richard B. Brewer, Scios'
president and chief executive officer. "This publication is important and
should help in our efforts to educate the medical community about Natrecor's
potential benefits to acute CHF patients."
Congestive Heart Failure - An Epidemic
A potentially life-threatening disorder that has no cure, heart failure is
a chronic pathophysiologic condition in which the heart functions
inefficiently and circulation is reduced to the body's organs. In congestive
heart failure, fluid accumulates in the tissues, including lung tissue,
causing such symptoms as difficulty breathing, swelling of the hands and feet,
difficulty sleeping, dry cough, fatigue and rapid weight gain. CHF may result
from an acute event (e.g., heart attack) or may develop gradually over time.
During an acute episode of CHF, the heart's inability to adequately
circulate blood throughout the body worsens beyond its already compromised
state, causing symptoms to become so pronounced that hospital treatment is
required to stabilize the patient's condition. A sudden increase in dietary
sodium (salt), failure to take chronic oral medications for managing CHF, or
the development of a new heart arrhythmia can precipitate an acute attack.
Roughly five million Americans suffer from heart failure, and there are
approximately one million hospitalizations each year in the U.S. for CHF which
cost the healthcare system $23 billion. In 1995, CHF treatments were the
largest annual expenditure for Medicare, costing nearly $3.4 billion. Another
two million Americans are hospitalized each year with CHF as the secondary
diagnosis. In the U.S., CHF accounts for the largest cause of
hospitalizations for patients over age 65. Virtually all CHF patients will
have at least one acute episode, where the symptoms are so severe that often
only intravenous (IV) medications administered in the hospital can improve
patients' health.
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 large and
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, 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; or Don Hyman of Edelman
Public Relations, 212-642-7741
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