-----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, VPny3cC5l//rZW3eTSOOvfw20wLBQYY+QYehMXfdiK1cED1ztF1hbZdOy/BRtKKc ZRfk5gvR7CqcnUZRQy6saw== 0000051396-96-000010.txt : 19960403 0000051396-96-000010.hdr.sgml : 19960403 ACCESSION NUMBER: 0000051396-96-000010 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19960401 ITEM INFORMATION: Other events FILED AS OF DATE: 19960402 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: 96543726 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 April 1, 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 April 1, 1996. The relevant portion of the text of that release was as follows: (An asterisk [*] indicates registered trademark.) MOLECULAR BIOSYSTEMS, MALLINCKRODT GROUP ANNOUNCE COMPLETION OF PHASE 3 CLINICAL TRIAL ON ULTRASOUND CONTRAST AGENT, FS069 SAN DIEGO, Ca., and ST. LOUIS, Mo., April 1, 1996 -- Molecular Biosystems, Inc. (NYSE:MB) (MBI) and Mallinckrodt Group Inc. (NYSE:MKG) today announced completion of patient enrollment in a Phase 3 clinical trial involving FS069, their next generation ultrasound contrast agent. The Phase 3 trial is the last of a series of critical studies completed which will be submitted to the U.S. Food and Drug Administration in support of obtaining regulatory approval to market FS069 for cardiac function indications. A filing is planned for the latter part of this year followed by a Pan-European submission for European approval. The Phase 3 trial was performed at 14 prominent institutions in the United States and enrolled a total of 200 patients who received diagnostic ultrasound (echocardiography) examinations of the heart. FS069 and ALBUNEX* (the only FDA approved ultrasound contrast agent currently on the market) were administered to all 200 patients. Both agents were studied for their ability to provide left ventricular opacification (LVO) and improvement in endocardial border delineation (EBD). The latter is essential in an echocardiographer's ability to diagnose regional and global wall motion abnormalities of the heart which in turn is a measure of the severity of coronary artery disease. In addition, the ability of FS069 to enhance Doppler signals was also measured, an important determinant of valvular heart disease. The final results will be presented later this year after complete analysis. "The early findings from this Phase 3 clinical trial further reinforces our belief in the high safety and efficacy profile of this contrast agent," said Kenneth J. Widder, M.D., Chairman and CEO of Molecular Biosystems. "With the numerous strengths of our partner, Mallinckrodt Medical, Inc., who will continue the clinical development of FS069 for non-cardiac indications, I am very confident that we will maintain our leadership position in this field." 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 business, 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 actual results of the trials described herein may differ from the Company's expectations discussed. Among the factors that could result in a materially different outcome are the inherent uncertainties accompanying new product development and the actions of regulatory authorities. # # # MALLINCKRODT GROUP INC. ROGER A. KELLER Vice President, Secretary and General Counsel DATE: April 2,1996 -----END PRIVACY-ENHANCED MESSAGE-----