SUNNYVALE, Calif., July 10 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
announced today that it has received a letter from the U.S. Food and Drug
Administration (FDA) stating that the Natrecor(R) (nesiritide) New Drug
Application (NDA) is approvable. Scios has developed Natrecor as an
intravenous treatment for patients with acutely decompensated congestive heart
failure (CHF).
The approvable letter is the official communication from the FDA that the
agency is prepared to approve the NDA following finalization of Natrecor
labeling and completion of a pre-approval inspection. The FDA's
Cardiovascular and Renal Drugs Advisory Committee unanimously recommended
approval of Natrecor for the treatment of acute CHF on May 25, 2001.
"We are delighted to receive the approvable letter and are working closely
with FDA to complete the final steps to approval," said Richard B. Brewer,
Scios' president and chief executive officer.
When approved by the FDA, Natrecor will become the first new treatment for
acutely decompensated CHF in more than a decade. Natrecor is a recombinant
form of B-type natriuretic peptide (BNP), and would become the first
natriuretic peptide product available as a therapeutic in the United States.
Human BNP is a naturally occurring hormone in the body that aids healthy
functioning of the heart. Roughly five million Americans suffer from heart
failure, with 550,000 new cases diagnosed each year. There are approximately
one million hospitalizations each year in the United States due to acute CHF.
Conference Call
Scios executives will host a conference call and live audio webcast at
2:30 p.m. PDT (5:30 p.m. EDT) on Tuesday, July 10 to discuss Natrecor and its
next steps to commercialization. To participate, please call 800-474-8920 at
least 5 minutes prior to start time. To access the live webcast, please log
on to http://www.sciosinc.com approximately fifteen minutes prior to the call to
register, download and install any necessary audio software.
A replay of the live webcast will be made available on the Scios website
shortly after the conclusion of the call through July 18, 2001. A replay of
the telephonic conference call will be available by dialing 888-203-1112,
access code 713213. The telephone replay will be available through July 18,
2001.
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.
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 the timing of the final approval of Natrecor, 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 form 10-Q for the quarter ended March 31, 2001.
SOURCE Scios Inc.
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Related links:
http://www.sciosinc.com
CONTACT:
investors, David Gryska of Scios Inc.,
408-616-8325; or Ed Bisno, 212-704-8212, or media, Michelle Choi,
212-704-4580, both of Edelman Public Relations, for Scios Inc.
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