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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
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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 3, 1995
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SCIOS NOVA INC.
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(Exact Name of Registrant as Specified in Charter)
Delaware 0-11749 95-3701481
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(State of Other Jurisdiction (Commission (IRS Employer
of Incorporation) File Number) Identification No.)
2450 Bayshore Parkway, Mountain View, California 94043
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(Address of Principal Executive Offices)
Registrant's telephone number, including area code (415) 966-1550
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ITEM 5. OTHER EVENTS
On May 3, 1995, Scios Nova Inc. announced preliminary results of its
Phase III clinical study of AURICULIN-Registered Trademark- anaritide for the
treatment of acute renal (kidney) failure. The press release is attached
hereto as Exhibit 99.1 and incorporated herein by reference.
EXHIBITS.
99.1 Press Release dated May 3, 1995
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 NOVA INC.
Date: May 5, 1995 By: /s/ John H. Newman
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John H. Newman
Vice President of Legal Affairs
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INDEX TO EXHIBITS
SCIOS NOVA INC.
Report on Form 8-K dated May 5, 1995
Exhibit Description Method of Filing
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99.1 Press Release dated May 3, 1995 Filed electronically herewith
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EXHIBIT 99.1
SCIOS NOVA ANNOUNCES PRELIMINARY RESULTS OF ITS PHASE III
CLINICAL STUDY OF AURICULIN-Registered Trademark- ANARITIDE FOR THE TREATMENT OF
ACUTE RENAL FAILURE
MOUNTAIN VIEW, CA -- May 3, 1995 -- Scios Nova Inc. (Nasdaq:SCIO) today
announced that it has completed preliminary analysis of results from the
Company's Phase III clinical study of AURICULIN-Registered Trademark- anaritide
for the treatment of acute renal (kidney) failure (ARF). The analysis revealed
that AURICULIN did not reduce the need for dialysis in the broad patient
population, nor did the drug reduce mortality. The study did demonstrate,
however, that AURICULIN significantly reduced the need for dialysis in a
prospectively-defined subgroup of patients suffering from oliguric ARF (patients
with abnormally low urine output).
The 504-patient clinical study was conducted at more than 60 centers in the
United States and Canada over a period of 25 months. The study was designed to
evaluate the number of patients requiring acute dialysis at 14 days and
mortality at 21 days following treatment. The study was also designed to
evaluate certain prospectively-defined subgroups to determine if AURICULIN had a
more pronounced effect in specific populations of patients.
The oliguric subgroup represented approximately 25% of the 504-patient study.
In oliguric ARF patients, dialysis was required in 63% of the 61 patients
receiving AURICULIN compared to 87% of the 60 patients receiving placebo, a 28%
reduction (p = 0.003). Treatment with AURICULIN also significantly increased
the number of patients who survived for 21 days without requiring dialysis
(dialysis-free survival) from 8% in the placebo-treated patients to 28% in
patients treated with AURICULIN (p = 0.005). Treatment with AURICULIN did not
reduce mortality in oliguric patients.
"While the study did not achieve its defined endpoints in the overall patient
population, our preliminary analysis indicates that AURICULIN had a positive
effect in the prospectively-defined subgroup of oliguric patients," said Richard
L. Casey, Scios Nova chairman and chief executive officer. "These results must
be viewed with caution, however, due to the complexities associated with
multiple analyses of subgroups in a study of this size. We believe that an
additional clinical study or studies will be necessary in order to file an
application seeking marketing approval. However, we and our partner, Genentech,
Inc., will review the data and determine the next appropriate steps for the
development of AURICULIN. We will not meet our objective of filing an
application in 1995 for marketing approval."
Detailed results of the study will be presented at the Thirteenth International
Congress of Nephrology in Madrid, Spain on July 6.
AURICULIN is Scios Nova's proprietary form of a naturally-occurring hormone
called atrial natriuretic peptide (ANP). ANP is produced in the heart and has a
wide range of activities known to be important in both kidney and heart
function, including increasing the elimination
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of water and salt from the body. ANP increases the flow of blood into the
filtration units of the kidney and constricts the flow of blood out of these
units. This action restores the natural filtering function of this organ.
ARF is a life-threatening condition characterized by an acute, severe and
sustained decrease in renal function. This condition, for which there is no
available treatment, is caused primarily by a temporary decrease in blood flow
to the kidneys, such as in complicated surgery or after traumatic injury. It is
estimated that more than 160,000 people in the United States are afflicted with
ARF each year. Based on the results of the study announced today, the Company
estimates that approximately 25% of ARF patients are oliguric.
Scios Nova is a biopharmaceutical company engaged in the discovery, development
and commercialization of novel human therapeutics. Scios Nova focuses its
research and development efforts on the treatment of acute illnesses, primarily
in the areas of cardio-renal disease and inflammation. The Company is also
collaborating with corporate partners in the development of FIBLAST-TM- bFGF for
wound healing, insulinotropin for Type II diabetes and novel therapies for
Alzheimer's disease.
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Release No. 9-95
Contact: Kira Bacon, 415/940-6629
