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                                                       8
  
  
  
   SF_DOCS\280878.1 [W97]
  
  
  
  
  
   SF_DOCS\280878.1 [W97]
  
  <H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>SECURITIES
  AND EXCHANGE COMMISSION</FONT></H1>
  
  <H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>WASHINGTON,
  D.C. 20549</FONT></H1>
  
  <HR SIZE=1 NOSHADE WIDTH=15% ALIGN=CENTER>
  
  <H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>FORM 8-K</FONT></H1>
  
  <H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>CURRENT
  REPORT</FONT></H1>
  
  <H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>PURSUANT TO
  SECTION 13 OR 15(d) OF THE</FONT></H1>
  
  <H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>SECURITIES
  EXCHANGE ACT OF 1934</FONT></H1>
  
                                      Date of Report (Date of earliest event reported): May 25, 2001
  
  
                                                                SCIOS, INC.
  <HR SIZE=1 NOSHADE WIDTH=15% ALIGN=CENTER>
  
                                            (Exact Name of Registrant as Specified in Charter)
  
  
                Delaware__                                0-11749                               95-3701481
   --------------------------------------     ---------------------------------         ------------------
      (State or Other Jurisdiction of             (Commission File Number)         (I.R.S. Employer Identification No.)
               Incorporation)
  
  
                                        820 West Maude Avenue, Sunnyvale, CA 94086
                           -------------------------------------------------------
                                   (Address of Principal Executive Offices) (Zip Code)
                                                  (408) 616-8200_
                       ------------------------------------------
                                  (Registrant's telephone number, including area code)
  
                                                        N/A
                             ------------------------------
                              (Former Name or Former Address, if Changed Since Last Report)
  
  
  
  
  
  
  
  <PAGE>
  
  
  <H2 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Item 5. Other
  Events.</FONT></H2>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>On May 25, 2001, Scios,
  Inc. announced that the Cardiovascular and Renal Drugs Advisory Committee to the
  U.S. Food and Drug Administration unanimously recommended approval of
  Natrecor&#174; (nesiritide) for the treatment of acute congestive heart failure.
  For additional information, refer to the press release attached as an exhibit to
  this Current Report on Form 8-K. The contents of the press release are
  incorporated by reference herein. </FONT></P>
  
  Item 7.  Financial Statements, Pro Forma Financial Information and Exhibits.
  
  (c)               Exhibits
  
                    The following exhibits are filed as part of this Report:
  
                    No.      Exhibit
                    ---      -------
                    99.1     Press Release dated May 25, 2001
  
  
  
  
  
  <PAGE>
  
  
  <H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>SIGNATURES</FONT></H1>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Pursuant
  to the requirements of the Securities Exchange Act of 1934, the registrant has
  duly caused this report to be signed on its behalf by the undersigned hereunto
  duly authorized. </FONT></P>
  
                                              SCIOS, INC.
  
  
                                              By:               /s/  John H. Newman____
                                                       --------------------------------
                                                       John H. Newman
                                                       Senior Vice President, General Counsel and Secretary
  
  
  Date:  May 29, 2001
  
  
  
  <PAGE>
  
  
  <H1 ALIGN=CENTER><FONT FACE="Times New Roman, Times, Serif" SIZE=2>EXHIBIT INDEX</FONT></H1>
  
  No.      Exhibit
  ---      -------
  99.1     Press Release dated May 25, 2001
  
  
  <PAGE>
  
  
  
                                                                                                           Exhibit 99.1
                                                                                                           ------------
  
  Contact:
  --------
  Wendy Carhart, Scios Inc. (408) 616 8325
  Jim Weiss, Weisscomm (415) 203 0328
  Michelle Choi, Edelman Public Relations (212) 704 4580
  
  SCIOS ANNOUNCES FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS APPROVAL OF NATRECOR FOR ACUTE CONGESTIVE HEART FAILURE
  
  Drug Could Become First New Acute CHF Treatment in Over a Decade
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2><B>SUNNYVALE, CA,</B> May
  25, 2001 &#150; 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<SUP>&#174;</SUP> (nesiritide) for the treatment of acute congestive
  heart failure (CHF) by a vote of 10-0. </FONT></P>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>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. </FONT></P>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&#147;Natrecor is now one
  step closer to approval and helping physicians manage acute CHF patients, which
  are growing in number every year,&#148; said Darlene P. Horton, M.D.,
  Scios&#146; Vice President of Medical Affairs. &#147;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.&#148; </FONT></P>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>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&#146;s final decision may differ. We expect
  the FDA to make its decision in July 2001. </FONT></P>
  
  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).
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>&#147;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,&#148; said Richard B. Brewer,
  Scios&#146; President and Chief Executive Officer. &#147;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.&#148; </FONT></P>
  
  <H2 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Clinical Trial
  Results</FONT></H2>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Presenters at today&#146;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&#146;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. </FONT></P>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>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. </FONT></P>
  
  <H2 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Congestive
  Heart Failure &#150; An Epidemic</FONT></H2>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>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&#146;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. </FONT></P>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>During an acute episode of
  CHF, the heart&#146;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&#146;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. </FONT></P>
  
  <H2 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>I. CONFERENCE
  CALL DETAILS</FONT></H2>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>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&#146; Web site at
  <U>www.sciosinc.com</U>. 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. </FONT></P>
  
  <H2 ALIGN=LEFT><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Scios Inc.</FONT></H2>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>Scios is a
  biopharmaceutical company developing novel treatments for heart failure and
  rheumatoid arthritis. The company&#146;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 www.sciosinc.com and in the company&#146;s various filings
  with the Securities and Exchange Commission (SEC). </FONT></P>
  
  <P><FONT FACE="Times New Roman, Times, Serif" SIZE=2>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&#146;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. </FONT></P>
  </BODY>
  </HTML>
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text: 8
  
   SF_DOCS\280878.1 [W97]
  
   SF_DOCS\280878.1 [W97]
  SECURITIES
  AND EXCHANGE COMMISSION
  WASHINGTON,
  D.C. 20549
  FORM 8-K
  CURRENT
  REPORT
  PURSUANT TO
  SECTION 13 OR 15(d) OF THE
  SECURITIES
  EXCHANGE ACT OF 1934
  Date of Report (Date of earliest event reported): May 25, 2001
  
                                                                SCIOS, INC.
  (Exact Name of Registrant as Specified in Charter)
  
                Delaware__                                0-11749                               95-3701481
   --------------------------------------     ---------------------------------         ------------------
      (State or Other Jurisdiction of             (Commission File Number)         (I.R.S. Employer Identification No.)
               Incorporation)
  
                                        820 West Maude Avenue, Sunnyvale, CA 94086
                           -------------------------------------------------------
                                   (Address of Principal Executive Offices) (Zip Code)
                                                  (408) 616-8200_
                       ------------------------------------------
                                  (Registrant's telephone number, including area code)
  
                                                        N/A
                             ------------------------------
                              (Former Name or Former Address, if Changed Since Last Report)
  Item 5. Other
  Events.
  On May 25, 2001, Scios,
  Inc. announced that the Cardiovascular and Renal Drugs Advisory Committee to the
  U.S. Food and Drug Administration unanimously recommended approval of
  Natrecor® (nesiritide) for the treatment of acute congestive heart failure.
  For additional information, refer to the press release attached as an exhibit to
  this Current Report on Form 8-K. The contents of the press release are
  incorporated by reference herein.
  Item 7.  Financial Statements, Pro Forma Financial Information and Exhibits.
  
  (c)               Exhibits
  
                    The following exhibits are filed as part of this Report:
  
                    No.      Exhibit
                    ---      -------
                    99.1     Press Release dated May 25, 2001
  SIGNATURES
  Pursuant
  to the requirements of the Securities Exchange Act of 1934, the registrant has
  duly caused this report to be signed on its behalf by the undersigned hereunto
  duly authorized.
  SCIOS, INC.
  
                                              By:               /s/  John H. Newman____
                                                       --------------------------------
                                                       John H. Newman
                                                       Senior Vice President, General Counsel and Secretary
  
  Date:  May 29, 2001
  EXHIBIT INDEX
  No.      Exhibit
  ---      -------
  99.1     Press Release dated May 25, 2001
  Exhibit 99.1
                                                                                                           ------------
  
  Contact:
  --------
  Wendy Carhart, Scios Inc. (408) 616 8325
  Jim Weiss, Weisscomm (415) 203 0328
  Michelle Choi, Edelman Public Relations (212) 704 4580
  
  SCIOS ANNOUNCES FDA ADVISORY COMMITTEE UNANIMOUSLY RECOMMENDS APPROVAL OF NATRECOR FOR ACUTE CONGESTIVE HEART FAILURE
  
  Drug Could Become First New Acute CHF Treatment in Over a Decade
  SUNNYVALE, CA,
  May
  25, 2001 – 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
  ®
  (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.
  I. 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
  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 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.