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 2, 1997
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 (415) 966-1550
<PAGE>
Item 5. Other Events
On April 2, 1997, Scios Inc. announced that it suspended development of
AURICULIN(R) anaritide for the treatment of oliguric acute renal (kidney)
failure based upon the results of an interim analysis of data. The press release
is attached hereto as Exhibit 99.2 and incorporated herein by reference.
Exhibits.
99.2 Press Release dated April 2, 1997
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.
/s/ John H. Newman
Date: April 2. 1997 By:
John H. Newman
Vice President of Legal Affairs
<PAGE>
INDEX TO EXHIBITS
SCIOS INC.
Report on Form 8-K dated April 2, 1997
Exhibit Description Method of Filing
- ------- ----------- ----------------
99.2 Press Release dated April 2, 1997 Filed electronically herewith
EXHIBIT 99.2
SCIOS SUSPENDS DEVELOPMENT OF AURICULIN
FOR OLIGURIC ACUTE RENAL FAILURE
Mountain View, CA - April 2, 1997 - Scios Inc. (Nasdaq: SCIO) today announced
that it has suspended development of AURICULIN(R) anaritide based upon the
results of an interim analysis of data from an ongoing 250-patient Phase III
study in oliguric acute renal failure. The study was suspended due to the low
probability that a positive outcome could be obtained with respect to its
primary clinical endpoint, dialysis-free survival.
"We are disappointed that the results of this pivotal Phase III clinical trial
of AURICULIN in oliguric acute renal failure failed to confirm the positive
results we observed in a subgroup of patients in our first Phase III acute renal
failure trial," said Richard L. Casey, chairman and chief executive officer.
"Despite this development, we remain optimistic about the viability of the other
products in our pipeline. Specifically, we still expect to achieve our goal of
filing a New Drug Application for NATRECOR(R) BNP in the first half of 1998. In
addition, FIBLAST(R) trafermin is showing promise in a number of indications.
Members of our clinical, regulatory and product development staffs who have been
involved in the development of AURICULIN will be assigned to either NATRECOR,
for acute congestive heart failure, or FIBLAST, for a variety of vascular and
neurological disorders."
AURICULIN was under development in collaboration with Genentech, Inc. The two
companies will be discussing the future of their collaboration over the next
several months.
Except for historical information contained herein, this news release contains
forward-looking statements that involve risks and uncertainties, including the
timing and outcome of product development activities, as well as the other risks
detailed from time to time in the Company's SEC reports, including the report on
Form 10-K for the year ended December 31, 1996 and reports on form 10-Q for
subsequent quarters.
Scios is a biopharmaceutical company engaged in the discovery, development,
manufacture and commercialization of novel human therapeutics. Scios has two
major clinical development programs. NATRECOR(R) BNP is in Phase III clinical
studies for the treatment of acute congestive heart failure. FIBLAST(R)
trafermin is in Phase II clinical trials for a variety of neurological and
vascular conditions. The Company has research and development collaborations
with Wyeth-Ayerst Laboratories, the pharmaceutical division of American Home
Products Corporation, Kaken Pharmaceutical Co., Ltd. and Novo Nordisk A/S of
Denmark. Scios' profitable commercial operations division markets six
psychiatric products.
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Release No. 3-97
Contact: Anne Bowdidge, Scios Inc. 415/ 962-5814
