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 31, 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 31, 1997. The relevant portion of
the text of that release was follows:
(*) Indicates registered trademark.
MARKETING AUTHORIZATION APPLICATION ACCEPTED FOR ULTRASOUND IMAGING
AGENT, FS069, IN THE EUROPEAN UNION
ST. LOUIS, Mo., and San Diego, Calif., March 31, 1997 -
Mallinckrodt Inc. (NYSE:MKG) and Molecular Biosystems, Inc. (NYSE:MB)
(MBI) today jointly announced that a Marketing Authorization
Application (MAA) for MBI's second generation imaging agent, FS069,
was formally accepted as filed by the European Medicines Evaluation
Agency (EMEA).
In late February, FS069 was submitted under the new centralized
application procedures established by the European Union and known as
the "fast track" review process. Under these new procedures, the MAA
or "dossier" will be reviewed by the EMEA. When approved, FS069 may
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.
"Mallinckrodt is eager to bring FS069 to the European
marketplace," said James C. Carlile, president of Mallinckrodt's
Medical Imaging Division. "European clearance will allow us to
provide the benefits of FS069 to cardiovascular patients in all
countries of the European Union."
Kenneth J. Widder, M. D., Molecular Biosystems' chairman and
chief executive officer, said, "We are delighted that the EMEA has
accepted our filing for FS069. This news, in conjunction with the
very positive outcome of our recent FDA panel meeting, brings our
flagship product one step closer to worldwide commercialization. We
believe that FS069 is a truly superior imaging agent and that it will
become an important contributor to our growth in the future."
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: April 1, 1997
