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 6, 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
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Item 5. Other Events
A press release was issued March 6, 1997. The relevant portion of
the text of that release was as follows:
(*)Indicates registered trademark
MALLINCKRODT, MOLECULAR BIOSYSTEMS FILE FOR MARKETING CLEARANCE OF
ULTRASOUND IMAGING AGENT, FS069, IN EUROPEAN UNION
ST. LOUIS, Mo., and San Diego, Calif., March 6, 1997 - Mallinckrodt
Inc. (NYSE:MKG) and Molecular Biosystems, Inc. (NYSE:MB) (MBI) today
jointly announced that a Marketing Authorization Application (MAA)
was filed with the European Medicines Evaluation Agency (EMEA) for
FS069, MBI's second generation agent. FS069 is designed to enhance
ultrasound imaging by enabling physicians to visualize blood flow and
enhance resolution of anatomical structure where ultrasound alone is
inadequate.
FS069 will be reviewed under the new centralized application
procedures established by the European Union and known as the "fast
track" review process. Upon receiving clearance from the EMEA, the
product will be marketed by Mallinckrodt in all countries of the
European Union - Austria, Germany, United Kingdom, France, Ireland,
Italy, Spain, Portugal, Sweden, Finland, Denmark, Belgium,
Luxembourg, the Netherlands and Greece.
The MAA filed with the EMEA is for the use of FS069 with
echocardiography (ultrasound imaging of the heart) for enhancing
images in the assessment of cardiac function, which includes the
visualization of endocardial borders and left ventricular
opacification.
The ability to visualize cardiac anatomy is important in the
echocardiographer's diagnosis of regional and global wall motion
abnormalities, which in turn may be a measure of the severity of
coronary artery disease. Additionally, Doppler signal enhancement,
which provides important information about blood flow in cardiac
valves and vessels, was also included in the submission.
"We believe FS069 will be a significant tool in enhancing
ultrasound imaging for cardiovascular indications," said James C.
Carlile, president of Mallinckrodt's Medical Imaging Division. "We
look forward to receiving European clearance so we can bring the
benefits of FS069 to patients in all countries of the European
Union."
Kenneth J. Widder, M. D., Molecular Biosystems' chairman and
chief executive officer, said, "With the recent unconditional
recommendation for FS069 from the advisory panel to the FDA and the
filing of our European submission, we continue to position ourselves
for the global commercialization of our second-generation imaging
agent. All of us at MBI are excited to be partnered with the
Mallinckrodt team, a major player in the European contrast media
market, and look forward to receiving marketing clearance from the
regulatory agency."
MBI, based in San Diego, Calif., is a world leader in the
development and manufacture of ultrasound contrast agents for medical
imaging. MBI shares are listed on the New York Stock Exchange under
the symbol "MB." ALBUNEX*, the first FDA-cleared ultrasound imaging
agent, is currently marketed in the United States by Mallinckrodt.
Mallinckrodt is a dynamic, international growth company serving
specialty markets in human healthcare and chemicals and is dedicated
to improving healthcare and chemistry. Mallinckrodt is a major
producer of analgesic pharmaceuticals, diagnostic imaging agents,
medical devices, catalysts, and laboratory and microelectronic
chemicals. The St. Louis-based company, with fiscal 1996 net sales
of $2.2 billion, sells more than 2,000 products in more than 100
countries. Mallinckrodt employs about 10,400 people worldwide. The
Mallinckrodt web site can be found at (www.mallinckrodt.com)
This news release contains forward-looking statements that
involve risks and uncertainties. The actual timing of the FDA or
EMEA approval for FS069 cardiac function indication may differ
materially from the companies' expectations. Among the factors that
could result in a materially different outcome are the actions of
regulatory authorities and the inherent uncertainties involved in the
development of a new product.
Mallinckrodt Inc.
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: March 10, 1997
