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
October 18, 1996
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
<PAGE>
Item 5. Other Events
A press release was issued October 18, 1996. The relevant portion of
the text of that release was as follows:
(*)Indicates registered trademark
MOLECULAR BIOSYSTEMS, MALLINCKRODT FILE FOR PMA
FOR NEXT GENERATION ULTRASOUND IMAGING AGENT, FS069
ST. LOUIS, Mo., and San Diego, Calif., October 18, 1996 -- Molecular
Biosystems, Inc. (NYSE:MB) (MBI) and Mallinckrodt Inc. (NYSE:MKG)
jointly announced today that they have filed a pre-marketing approval
(PMA) application with the U. S. Food and Drug Administration (FDA)
for FS069, MBI's second-generation ultrasound imaging agent. FS069
is designed to enhance ultrasound imaging by enabling physicians to
visualize blood flow and enhance resolution of anatomical structures
in those patients with suboptimal non-contrast ultrasound
examinations.
This submission involves studies for cardiac function focusing
on enhancing endocardial border delineation (EBD) and secondarily
determining the ability of the agent to opacify the left ventricular
chamber (LVO). Additionally, Doppler signal enhancement, which
provides important information about blood flow in cardiac valves and
vessels, was also studied.
"We are very pleased to announce the submission of this PMA for
FS069. The filing marks the most important achievement for MBI in
calendar year 1996," said Kenneth J. Widder, M. D., chairman and CEO
of Molecular Biosystems. "MBI is the only company in the world that
has been cleared by the FDA to market an ultrasound imaging agent.
We believe this experience is an important advantage in what is
promising to be a highly competitive field. The company is currently
involved in additional clinical studies for FS069, including
myocardial perfusion and radiology imaging trials."
James C. Carlile, president of Mallinckrodt's Medical Imaging
Division, said: "We are pleased to continue in partnership with MBI
as we both pursue approval for FS069. Mallinckrodt is an established
leader in a number of medical imaging product lines. Our partnership
with MBI and its ultrasound products helps us better serve the
overall imaging needs of healthcare professionals."
The Phase III study submitted as part of the PMA comprised 203
patients from 14 leading U. S. institutions in which FS069 was
compared to ALBUNEX(*), MBI's first generation ultrasound contrast
agent, marketed by Mallinckrodt. Results of the trial demonstrated
the superiority of FS069 to ALBUNEX(*) in providing significant
improvement of endocardial border delineation as well as left
ventricular contrast enhancement, thus enabling the visualization of
regional and global wall motion and function. Additionally, dosages
as low as 0.2 milliliters of FS069 significantly enhanced Doppler
signals in these patients.
Comprehensive review of the previously disclosed test data
demonstrated that endocardial border delineation, a primary endpoint
of this study, improved in at least one border segment to a
diagnostic level in 93 percent of all patients after the
administration of 3.0 milliliters of FS069. In addition, two-thirds
or more filling of the left ventricle was demonstrated at the 3.0
milliliter dose in 94.5 percent of all patients. More importantly,
of those patients with cardiac and/or pulmonary dysfunction, a
subgroup in whom first generation contrast agents may be less
effective, improvement in endocardial border delineation was seen in
93 percent and two-thirds or greater left ventricular filling was
seen in 94.1 percent.
FS069 is licensed to Mallinckrodt Inc. in North and South
America, China, Australia and New Zealand. MBI developed and
manufactures FS069 while Mallinckrodt is responsible for sales and
marketing. MBI is currently in advanced discussions with a European
partner and is actively pursuing discussions for its recently
reacquired Far East territories.
Molecular Biosystems, Inc., based in San Diego, Calif., is a
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.
MBI shares are listed on the New York Stock Exchange under the symbol
"MB."
Mallinckrodt (NYSE:MKG) is an international growth company
serving specialty markets in human healthcare and chemicals.
Dedicated to improving healthcare and chemistry, 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 2,000 products in more
than 100 countries. Mallinckrodt employs about 10,400 people
worldwide. The Mallinckrodt web site address is
www.mallinckrodt.com.
This news release contains forward-looking statements that involve
risk and uncertainties. The outcome of the submission may differ
from the companies' expectations. Among the factors that could
result in a materially different outcome are the actions of the
regulatory authorities and uncertainties inherent in the development
of a new product.
# # #
Mallinckrodt Inc.
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: October 22, 1996
