-----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, TAP2k2RSmogEO9GYwwVDkPtG0uFgqHxTjSi5d0qtSyQ3DFkUsiI3axUc1/5nD3As v2Y2uwZus1euo9FYxQWl/A== 0000051396-96-000007.txt : 19960329 0000051396-96-000007.hdr.sgml : 19960329 ACCESSION NUMBER: 0000051396-96-000007 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19960327 ITEM INFORMATION: Other events FILED AS OF DATE: 19960328 SROS: CSX SROS: NYSE SROS: PSE FILER: COMPANY DATA: COMPANY CONFORMED NAME: MALLINCKRODT GROUP INC CENTRAL INDEX KEY: 0000051396 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 361263901 STATE OF INCORPORATION: NY FISCAL YEAR END: 0630 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-00483 FILM NUMBER: 96540160 BUSINESS ADDRESS: STREET 1: 7733 FORSYTH BLVD CITY: ST LOUIS STATE: MO ZIP: 63105 BUSINESS PHONE: 3148545299 MAIL ADDRESS: STREET 1: 7733 FORSYTH BLVD CITY: ST LOUIS STATE: MO ZIP: 63105 FORMER COMPANY: FORMER CONFORMED NAME: IMCERA GROUP INC DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: INTERNATIONAL MINERALS & CHEMICAL CORP DATE OF NAME CHANGE: 19900614 8-K 1 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 March 27, 1996 Mallinckrodt Group Inc. (Exact name of registrant as specified in its charter) New York 1-483 36-1263901 (State or other jurisdiction (Commission (I.R.S. Employer of incorporation) File Number) Identification No.) 7733 Forsyth Boulevard, St. Louis, MO 63105-1820 (Address of principal executive offices) (ZIP Code) Registrant's telephone number, (314)854-5200 including area code Item 5. Other Events A press release was issued March 27, 1996. The relevant portion of the text of that release was as follows: (An asterisk [*] indicates registered trademark.) PHASE 2 FS069 MYOCARDIAL CONTRAST ECHO RESULTS PRESENTED AT THE AMERICAN COLLEGE OF CARDIOLOGY SAN DIEGO, Ca. and ST. LOUIS, Mo., March 27, 1996 -- Molecular Biosystems, Inc. (NYSE:MB) (MBI) and Mallinckrodt Group Inc. (NYSE:MKG) today jointly announced that the preliminary results from their Phase 2 myocardial perfusion study on FS069, MBI's second generation ultrasound contrast agent, were reported yesterday at the American College of Cardiology (ACC) annual scientific sessions in Orlando, Florida. Dr. Sanjiv Kaul, Professor of Medicine, Division of Cardiology at the University of Virginia Charlottesville, presented the results on 30 patients with known or suspected ischemic coronary artery disease. The clinical trial compared myocardial perfusion identified by pharmacologic stress nuclear imaging (the current "gold standard" for determining myocardial perfusion) to those images obtained by myocardial contrast echocardiography (MCE) using FS069 in these same patients. Dr. Kaul reported no adverse effects were observed in patients receiving FS069, reinforcing the high safety profile of this ultrasound contrast agent even in the presence of dipyridamole, a potent pharmacological stress agent which increases myocardial blood flow. The concordance between nuclear perfusion imaging and FS069 MCE for the presence or absence of abnormal perfusion was 92% (p<0.0001). Thus, based on the data, FS069 stress MCE with harmonic imaging may provide at least the same diagnostic accuracy as stress nuclear imaging. A larger Phase 3 study will be conducted to more fully substantiate these findings. This study is the first demonstration in humans of the use of MCE as a stress perfusion diagnostic technique compared with a validated and accepted technique for myocardial perfusion. The study will be submitted for publication in a major medical journal this Spring. Currently, echocardiography does not provide blood flow (perfusion) information. This new technique will provide simultaneous assessment of both perfusion and function within the same myocardial region. If confirmed, these results suggest that FS069 myocardial contrast echocardiography has the potential to favorably compete with nuclear imaging as a means of identifying regions of the heart receiving inadequate blood supply. Molecular Biosystems, Inc., based in San Diego, California, is a world leader in the development of ultrasound contrast agents for medical imaging. ALBUNEX*, the first FDA approved ultrasound imaging agent is currently marketed in the United States by Mallinckrodt Medical, Inc. (Mallinckrodt Group Inc. NYSE:MKG). MBI shares are listed on the New York Stock Exchange under the symbol "MB." Mallinckrodt Group is a St. Louis-based company with fiscal 1995 net sales of $2 billion. Through its technology-based businesses, it provides more than 2,000 human and animal health and specialty chemical products in more than 100 countries. This news release contains forward looking statements that involve risk and uncertainties. The development of FS069 may differ materially from the Company's expectations. Among the factors that could result in a materially different outcome are the inherent uncertainties accompanying new product development, actions of regulatory authorities and the results of further trials, including the phase 3 study contemplated. # # # MALLINCKRODT GROUP INC. ROGER A. KELLER Vice President, Secretary and General Counsel DATE: March 28, 1996 -----END PRIVACY-ENHANCED MESSAGE-----