-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, O0TIsGXTA8UyTGXJoQuVloBq5a3z+QP22lctaRSYWw3kwHA5r68v2x+Y3ZuzYZ+h kAa0KuwW03mlF2S3Ms20Ag== 0000726512-97-000006.txt : 19970404 0000726512-97-000006.hdr.sgml : 19970404 ACCESSION NUMBER: 0000726512-97-000006 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19970402 ITEM INFORMATION: Other events FILED AS OF DATE: 19970403 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: SCIOS INC CENTRAL INDEX KEY: 0000726512 STANDARD INDUSTRIAL CLASSIFICATION: WHOLESALE-DRUGS PROPRIETARIES & DRUGGISTS' SUNDRIES [5122] 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: 97573900 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) 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 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 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 EX-99 2 EXHIBIT 99.2 - PRESS RELEASE DATED 4/2/97 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. ### Release No. 3-97 Contact: Anne Bowdidge, Scios Inc. 415/ 962-5814 -----END PRIVACY-ENHANCED MESSAGE-----