-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: keymaster@town.hall.org Originator-Key-Asymmetric: MFkwCgYEVQgBAQICAgADSwAwSAJBALeWW4xDV4i7+b6+UyPn5RtObb1cJ7VkACDq pKb9/DClgTKIm08lCfoilvi9Wl4SODbR1+1waHhiGmeZO8OdgLUCAwEAAQ== MIC-Info: RSA-MD5,RSA, PE53WPKKQ3FIUgBmXhTG2jbkyQj8uB3DBESB0KVwAaDquifgBm0SjpnRWWqtURb7 RuDA1mJzqTTL9VANXJHDMA== 0000912057-95-003244.txt : 19950508 0000912057-95-003244.hdr.sgml : 19950508 ACCESSION NUMBER: 0000912057-95-003244 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19950503 ITEM INFORMATION: Other events FILED AS OF DATE: 19950505 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: SCIOS NOVA INC CENTRAL INDEX KEY: 0000726512 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 953701481 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-11749 FILM NUMBER: 95535026 BUSINESS ADDRESS: STREET 1: 2450 BAYSHORE PKWY CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 BUSINESS PHONE: 4159661550 MAIL ADDRESS: STREET 1: 2450 BAYSHORE PARKWAY CITY: MOUNTAIN VIEW STATE: CA ZIP: 94043 FORMER COMPANY: FORMER CONFORMED NAME: SCIOS INC DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: CALIFORNIA BIOTECHNOLOGY INC DATE OF NAME CHANGE: 19920302 8-K 1 FORM 8-K 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) May 3, 1995 ----------- SCIOS NOVA 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 -------------- 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 ------------------------------------ John H. Newman Vice President of Legal Affairs 2 INDEX TO EXHIBITS SCIOS NOVA INC. Report on Form 8-K dated May 5, 1995 Exhibit Description Method of Filing - ------- ----------- ---------------- 99.1 Press Release dated May 3, 1995 Filed electronically herewith 3 EX-99.1 2 EXHIBIT 99.1 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 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. # # # Release No. 9-95 Contact: Kira Bacon, 415/940-6629 -----END PRIVACY-ENHANCED MESSAGE-----