SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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) April 27, 1999
SCIOS INC.
(Exact Name of Registrant as Specified in Charter)
Delaware 0-11749 95-3701481
(State of Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
2450 Bayshore Parkway, Mountain View, California 94043
(Address of Principal Executive Offices)
Registrant's telephone number, including area code (650) 966-1550
<PAGE>
Item 5. Other Events
On April 27, 1999, Scios Inc. announced that the U.S. Food and Drug
Administration did not approve the company's new drug application (NDA) for
Natrecor(R) (nesiritide) in the treatment of acute episodes of congestive heart
failure. The agency determined that there are uncertainties remaining about the
effectiveness and safety of Natrecor at this time necessitating further study of
the drug. The press release is attached hereto as Exhibit 99.1 and incorporated
herein by reference.
Exhibits.
99.1 Press Release dated April 27, 1999
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this amendment to be signed on its behalf of the
undersigned, thereunto duly authorized.
SCIOS INC.
Date: April 28, 1999 By: s/s John H. Newman
John H. Newman
Senior Vice President
<PAGE>
INDEX TO EXHIBITS
SCIOS INC.
Report on Form 8-K dated April 28, 1999
Exhibit Description Method of Filing
99.1 Press Release dated April 27, 1999 Filed electronically herewith
<PAGE>
Exhibit 99.1
NATRECOR(R) NEW DRUG APPLICATION NOT APPROVED BY FDA
-- Additional data required for approval--
MOUNTAIN VIEW, CALIFORNIA - April 27, 1999 - Scios Inc. (Nasdaq: SCIO) announced
today that the U.S. Food and Drug Administration did not approve the company's
new drug application (NDA) for Natrecor(R) (nesiritide) in the treatment of
acute episodes of congestive heart failure (CHF). Calling their action "a
particularly difficult decision," the agency determined there are uncertainties
remaining about the effectiveness and safety of Natrecor at this time
necessitating further study of the drug.
"We are disappointed in today's decision, nevertheless we will work closely with
the FDA to define what additional clinical studies are required for the approval
of Natrecor," said Richard B. Brewer, President and CEO of Scios Inc.
The FDA acknowledged that Natrecor reduced pulmonary capillary wedge pressure,
increased cardiac output, and produced some evidence of symptomatic benefit.
However, the agency determined that further study is needed to define the
consequences of the pharmacodynamic profile, specifically as it relates to the
onset of effect and the recovery from hypotension if it occurs.
- More -
Natrecor was developed by Scios Inc. In 1998 Scios entered into a commercial
alliance for the worldwide commercialization of Natrecor with Bayer AG.
The statements in this press release that are not historical facts are
forward-looking statements that involve risks and uncertainties, and may include
references to the ability to provide the additional data requested by the FDA
for the approval of Natrecor, as well as the other risks detailed from time to
time in the Company's SEC reports, including its annual report on Form 10-K for
the year ended December 31, 1998 and subsequent reports on Form 10-Q.
Scios is a biopharmaceutical company engaged in the discovery, development,
manufacture and commercialization of novel human therapeutics. In addition to
its Natrecor collaboration with Bayer AG, Scios has research and development
collaborations with Wyeth-Ayerst Laboratories, the pharmaceutical division of
American Home Products Corporation, Kaken Pharmaceutical Co., Ltd., Eli Lilly
and Company, The DuPont Pharmaceuticals Company and Novo Nordisk A/S of Denmark.
Scios' commercial operations division markets six psychiatric products.
Additional information on Scios is available at its web site located at
http://www.sciosinc.com and in the Company's various filings with the Securities
and Exchange Commission.
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