-----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, M8kfqVUUc/1nMWCCsY/jdLsNQKaGA7bSSrKcgn0mATrg8+4m5A/KZ89cbuyqlEqc tnEQY0ww2O3SynoMFhChCw== 0000051396-97-000027.txt : 19970428 0000051396-97-000027.hdr.sgml : 19970428 ACCESSION NUMBER: 0000051396-97-000027 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 19970423 ITEM INFORMATION: Other events FILED AS OF DATE: 19970425 SROS: CSX SROS: NYSE SROS: PSE FILER: COMPANY DATA: COMPANY CONFORMED NAME: MALLINCKRODT GROUP INC CENTRAL INDEX KEY: 0000051396 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] 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: 97587077 BUSINESS ADDRESS: STREET 1: 7733 FORSYTH BLVD CITY: ST LOUIS STATE: MO ZIP: 63105-1820 BUSINESS PHONE: 3148545299 MAIL ADDRESS: STREET 1: 7733 FORSYTH BLVD CITY: ST LOUIS STATE: MO ZIP: 63105-1820 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 23, 1997 Mallinckrodt 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 23, 1997. The relevant portion of the text of that release was as follows: (*) Indicates registered trademark. MALLINCKRODT SUPPORTING MOLECULAR BIOSYSTEMS IN FS069 CASE ST. LOUIS, Mo., April 23, 1997 - Mallinckrodt Inc. (NYSE:MKG) announced today that it is supporting its business partner, Molecular Biosystems, Inc. (MBI) (NYSE:MB) as MBI works through legal challenges that are delaying final review and approval for MBI's next-generation ultrasound imaging contrast agent, FS069. "We believe that FS069 meets the requirements for review as a medical device because it does not depend upon the metabolism of the body or chemical action to accomplish its purposes," said C. Ray Holman, chairman and chief executive officer of Mallinckrodt, which will be the marketer of FS069. "It is unfortunate that legal challenges are being used to keep patients from the benefits of FS069, which can enhance ultrasound visualization of the heart by enabling physicians to see blood flow and anatomical structure when ultrasound alone is inadequate. We hope to see these issues resolved soon so that FS069 can receive final review and begin benefiting patients. We are offering counsel, advice and support to MBI." The legal challenges were instigated by three MBI competitors who have their own ultrasound products now under review by the U. S. Food and Drug Administration. The competitors' products are not as far along in the review process as FS069, which was recommended in February for clearance without conditions by an FDA advisory panel. The challenges have resulted in the federal district court in Washington, D. C., enjoining the FDA from proceeding on review and market clearance for FS069 and the competitors' products until the FDA responds to citizens' petitions filed earlier this year. The petitions, also filed by MBI competitors, challenge the FDA's decision to review FS069 as a medical device while reviewing the competing products as drugs. MBI's first-generation ultrasound product, ALBUNEX(*), received clearance as a device. Late Tuesday, MBI filed a motion asking the district court to reconsider its decision. In addition, MBI filed a second motion asking the court to clarify whether it intended that all research work on the various companies' products be halted while the FDA is enjoined from review and clearance of the products. Mallinckrodt fully supports these actions. "We hope for a quick resolution of these matters," Holman said. Mallinckrodt serves healthcare and specialty chemicals markets worldwide. The company is a major producer of diagnostic imaging agents, medical devices, pain relief pharmaceuticals, catalysts, and laboratory and microelectronic chemicals. The St. Louis, Missouri-based company, with fiscal 1996 net sales of $2.2 billion, sells more than 1,000 products in more than 100 countries. The Mallinckrodt web site address is (www.mallinckrodt.com). # # # Mallinckrodt Inc. ROGER A. KELLER Vice President, Secretary and General Counsel DATE: April 24, 1997 -----END PRIVACY-ENHANCED MESSAGE-----