Scios Announces FDA Cardiovascular and Renal Drugs Advisory Committee To Review Natrecor New Drug Application

Apr 10, 2001, 01:00 ET from Scios Inc.

    SUNNYVALE, Calif., April 10 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
 announced today that the U.S. Food and Drug Administration's Cardiovascular
 and Renal Drugs Advisory Committee will review the company's New Drug
 Application (NDA) amendment for Natrecor(R) (nesitritide) for the treatment of
 acute congestive heart failure (CHF) on Friday, May 25, 2001.
 Scios submitted an amendment to its existing NDA for Natrecor at the beginning
 of this year, based largely on the findings of the 498-patient VMAC
 (Vasodilation in the Management of Acute Congestive heart failure) trial.  If
 approved, Natrecor would be the first new treatment for acute CHF in more than
 a decade.
     "We are pleased to have the opportunity to present all of the Natrecor
 data, particularly the VMAC data, to the FDA Advisory Committee," said
 Darlene P. Horton, M.D., Scios' Vice President of Medical Affairs.  "We have
 been working closely with the Agency and believe we can present a compelling
 case regarding the approvability of this drug."
     In addition to Dr. Horton from Scios, James B. Young, M.D., Chair, VMAC
 Steering Committee and 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, will present
 Natrecor data.
     "The Advisory Committee review of the data supporting the application for
 approval of Natrecor is an important step for Natrecor and an important event
 for other applications to follow for this indication," commented
 Richard B. Brewer, Scios' Chief Executive Officer.  "As we have indicated
 previously, we have been expecting and preparing for Advisory Committee
 review."
     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, primarily in a standard fixed dose
 regimen that not require titration (i.e., dose adjustments).  Roughly five
 million Americans suffer from heart failure, and there are approximately one
 million hospitalizations each year in the United States for acute heart
 failure.
     Immediately following the Advisory Committee meeting, Scios will host a
 conference call and webcast to discuss the results of the meeting.  The
 webcast and conference call will begin at 6:00 p.m. (ET) on Friday, May 25th.
 The webcast will be available on Scios' website, 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 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 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 and
 the Advisory Committee 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.
 
 

SOURCE Scios Inc.
    SUNNYVALE, Calif., April 10 /PRNewswire/ -- Scios Inc. (Nasdaq: SCIO)
 announced today that the U.S. Food and Drug Administration's Cardiovascular
 and Renal Drugs Advisory Committee will review the company's New Drug
 Application (NDA) amendment for Natrecor(R) (nesitritide) for the treatment of
 acute congestive heart failure (CHF) on Friday, May 25, 2001.
 Scios submitted an amendment to its existing NDA for Natrecor at the beginning
 of this year, based largely on the findings of the 498-patient VMAC
 (Vasodilation in the Management of Acute Congestive heart failure) trial.  If
 approved, Natrecor would be the first new treatment for acute CHF in more than
 a decade.
     "We are pleased to have the opportunity to present all of the Natrecor
 data, particularly the VMAC data, to the FDA Advisory Committee," said
 Darlene P. Horton, M.D., Scios' Vice President of Medical Affairs.  "We have
 been working closely with the Agency and believe we can present a compelling
 case regarding the approvability of this drug."
     In addition to Dr. Horton from Scios, James B. Young, M.D., Chair, VMAC
 Steering Committee and 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, will present
 Natrecor data.
     "The Advisory Committee review of the data supporting the application for
 approval of Natrecor is an important step for Natrecor and an important event
 for other applications to follow for this indication," commented
 Richard B. Brewer, Scios' Chief Executive Officer.  "As we have indicated
 previously, we have been expecting and preparing for Advisory Committee
 review."
     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, primarily in a standard fixed dose
 regimen that not require titration (i.e., dose adjustments).  Roughly five
 million Americans suffer from heart failure, and there are approximately one
 million hospitalizations each year in the United States for acute heart
 failure.
     Immediately following the Advisory Committee meeting, Scios will host a
 conference call and webcast to discuss the results of the meeting.  The
 webcast and conference call will begin at 6:00 p.m. (ET) on Friday, May 25th.
 The webcast will be available on Scios' website, 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 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 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 and
 the Advisory Committee 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.
 
 SOURCE  Scios Inc.