Drug Could Become First New Acute CHF Treatment in Over a Decade
SUNNYVALE, Calif., May 25 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
announced today that the Cardiovascular and Renal Drugs Advisory Committee to
the U.S. Food and Drug Administration (FDA) unanimously recommended approval
of Natrecor(R) (nesiritide) for the treatment of acute congestive heart
failure (CHF) by a vote of 10-0.
If approved by the FDA, Natrecor would be the first new treatment for
acute CHF in more than a decade. 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 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 typically does not require titration (i.e., dose
adjustments). Approximately five million Americans suffer from congestive
heart failure, and there are approximately one million hospitalizations each
year in the United States due to acute CHF.
"Natrecor is now one step closer to approval and helping physicians manage
acute CHF patients, which are growing in number every year," said
Darlene P. Horton, M.D., Scios' Vice President of Medical Affairs. "We
commend the clinical investigators and their teams at leading medical centers
around the country who made it possible to expedite high-quality clinical
trials evaluating Natrecor. We are very proud of this dedicated development
effort."
Based on the outcome of clinical trials involving nearly 1,000 patients
treated with Natrecor, Scios submitted an amendment to the New Drug
Application (NDA) for Natrecor to the FDA in early 2001. The original NDA was
filed with the FDA in April 1998. The FDA subsequently requested additional
data on Natrecor, which was included in the amended application filed in
January of 2001. Despite a positive Advisory Committee recommendation, the
FDA's final decision may differ. We expect the FDA to make its decision in
July 2001.
In anticipation of final FDA approval of Natrecor, Scios entered into a
commercialization and marketing agreement for Natrecor in the United States
with Innovex, the commercialization unit of Quintiles Transnational Corp.
(Nasdaq: QTRN).
"We are building a 180-person strong sales and marketing force that we
believe will be the largest and the most focused in the U.S. acute CHF
market," said Richard B. Brewer, Scios' President and Chief Executive Officer.
"We have hired two area business directors who will coordinate and lead the
field sales effort with the 18 business managers who will support the sales
force. We will be ready to launch the product at the end of July if Natrecor
is approved by the FDA."
Clinical Trial Results
Presenters at today's advisory committee meeting reviewed results of
several clinical trials, including the pivotal 498-patient VMAC (Vasodilation
in the Management of Acute Congestive heart failure) trial. The data
demonstrated Natrecor's ability to rapidly improve blood circulation and
reduce 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. Natrecor has also been shown to rapidly
alleviate patient symptoms, such as shortness of breath and fatigue. The most
common side effects have been headache, reversible hypotension, and abdominal
pain.
In addition to Dr. Horton, data was also presented to the Advisory
Committee by James B. Young, M.D., Head, Section of Heart Failure and Cardiac
Transplant Medicine and Medical Director of the Kaufman Center for Heart
Failure at the Cleveland Clinic Foundation, and William Abraham, M.D., Chief,
Division of Cardiovascular Medicine and Director, Section of Heart Failure and
Cardiac Transplantation, University of Kentucky College of Medicine.
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.
Conference Call Details
Scios will host a conference call and webcast this afternoon to discuss
the results of the meeting at 6:00 p.m. (EDT). The webcast will be available
on Scios' Web site at http://www.sciosinc.com. The conference call dial-in will be
800-314-7867. A replay of both the conference call and webcast will be
available through June 1, 2001. The replay dial-in number will be
888-203-1112, confirmation code 593777.
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 computational and
medicinal chemistry to identify novel targets and rationally design
small-molecule compounds to treat cardiovascular and inflammatory diseases,
for large markets with unmet medical needs. Additional information on Scios is
available on its Web site located at http://www.sciosinc.com and in the company's
various filings with the Securities and Exchange Commission (SEC).
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, 2000, and subsequent reports filed
on form 10-Q for the quarter ended March 31, 2001.
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 Michelle Choi of Edelman
Public Relations, 212-704 4580
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