Scios to Present Five Natrecor Abstracts at 4th Annual Heart Failure Society
Meeting
SUNNYVALE, Calif., Sep 11, 2000 /PRNewswire via COMTEX/ -- Scios Inc. (Nasdaq:
SCIO) today announced that researchers presented findings today at the Fourth
Annual Scientific Meeting of the Heart Failure Society of America evaluating its
investigational drug Natrecor(R) (nesiritide). Five abstracts on Natrecor will
be presented over the next three days at the meeting in Boca Raton, Florida.
Natrecor is Scios' recombinant form of B-type natriuretic peptide (BNP), a
hormone secreted by the heart in response to heart failure.
"These data further supplement our knowledge about Natrecor and will contribute
to the growing awareness of BNP in the cardiology community," said Darlene P.
Horton, M.D., vice president of medical affairs for Scios. "We are now focused
on completing data collection and analysis for the VMAC trial investigating
Natrecor, which should provide the additional information required to gain FDA
approval."
The VMAC (Vasodilation in the Management of Acute Congestive heart failure)
trial is designed to further evaluate the clinical benefits of Natrecor in
patients with acute congestive heart failure (aCHF). Results will be presented
for the first time at the American Heart Association annual meeting on
Wednesday, November 15. The company plans to submit an amendment to its New Drug
Application (NDA) for Natrecor by the end of 2000.
Two abstracts will be presented at the HFSA meeting with information on the
design of the VMAC trial and demographic characteristics of the first 134
patients enrolled in the VMAC trial. The abstracts are listed below, and copies
are available on Scios' website at sciosinc.com.
-- Young J for the VMAC Investigators, Stevenson LW, Abraham W, Horton D.
Rationale and Design of the VMAC trial: Vasodilation in the Management of Acute
Congestive Heart Failure. Based on the VMAC Trial
-- Young J for the VMAC Investigators, Abraham W, Horton D. Demographic
Characteristics of Patients in the VMAC trial (Vasodilation in the Management of
Acute Congestive Heart Failure). Based on the VMAC Trial
In addition, three abstracts will be presented with data from two previously
conducted studies of Natrecor, the PRECEDENT study and the Comparative Trial
(Scios Study 704.326). The PRECEDENT study (Prospective Randomized Evaluation of
Cardiac Ectopy with DobutaminE or Nesiritide Therapy) prospectively randomized
246 patients to either dobutamine (73 patients) or one of two doses of Natrecor
(152 patients). In the Comparative Trial, 305 patients were randomized to
standard care, or one of two doses of Natrecor. Results of the Comparative Trial
were published in the July 27 issue of The New England Journal of Medicine. The
abstracts with data from these studies are as follows:
-- Elkayam U, Silver M, Burger AJ, Horton D. The Effect of Short Term Therapy
with Nesiritide (B-type Natriuretic Peptide) or Dobutamine on Longterm Survival.
Based on the PRECEDENT Trial (704.329) and Scios Study 704.326
-- Burger AJ, Horton D, Elkayam U, LeJemtel T, Ghali J. Evidence of Ventricular
Ectopy at Baseline is Not Predictive of the Proarrhythmic Effects of Dobutamine
in the Treatment of Decompensated CHF: The PRECEDENT Study. Based on data from
the PRECEDENT Study (704.329)
-- Burger AJ, Horton D, Elkayam U, LeJemtel T, Ghali J. Comparison of the
Effects of Dobutamine and Nesiritide (B-type Natriuretic Peptide) on Cardiac
Ectopy in Acutely Decompensated Ischemic Versus Non-Ischemic Cardiomyopathies.
Based on data from the PRECEDENT Study (704.329)
"The expanding base of clinical data on Natrecor provides several useful
comparisons of Natrecor and existing treatments for acute CHF," added Dr.
Horton. "This and the VMAC trial data will substantially increase the
information available for physicians who treat patients with heart failure. As
there have been no new treatments approved for this indication in more than 12
years, new data evaluating therapies is particularly important."
Scios Inc.
Scios is a biopharmaceutical company engaged in the discovery, development, and
commercialization of novel human therapeutics. Scios has commercial or research
and development relationships with Chiron Corporation, DuPont Pharmaceuticals
Company; Eli Lilly and Company; GenVec, Inc.; Kaken Pharmaceutical Co., Ltd.;
and Novo Nordisk A/S, of Denmark. Additional information on Scios is available
at its web site located at 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
the risks concerning the success of the VMAC trial and regulatory approval of
Natrecor and the risk that the analysis described in these abstracts will be
supported in further studies, 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.
CONTACT: Investors, Wendy Carhart of Scios, Inc., 408-616-8325; or
Media, Jim Weiss of WeissComm, 415-203-0328, for Scios, Inc.
URL: sciosinc.com |
