<PAGE>
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 27, 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
</PAGE>
<PAGE>
Item 5. Other Events
A press release was issued March 27, 1996. The relevant portion of the
text of that release was as follows:
(An asterisk [*] indicates registered trademark.)
PHASE 2 FS069 MYOCARDIAL CONTRAST ECHO RESULTS PRESENTED AT THE AMERICAN
COLLEGE OF CARDIOLOGY
SAN DIEGO, Ca. and ST. LOUIS, Mo., March 27, 1996 -- Molecular
Biosystems, Inc. (NYSE:MB) (MBI) and Mallinckrodt Group Inc. (NYSE:MKG)
today jointly announced that the preliminary results from their Phase 2
myocardial perfusion study on FS069, MBI's second generation ultrasound
contrast agent, were reported yesterday at the American College of
Cardiology (ACC) annual scientific sessions in Orlando, Florida. Dr.
Sanjiv Kaul, Professor of Medicine, Division of Cardiology at the
University of Virginia Charlottesville, presented the results on 30
patients with known or suspected ischemic coronary artery disease. The
clinical trial compared myocardial perfusion identified by pharmacologic
stress nuclear imaging (the current "gold standard" for determining
myocardial perfusion) to those images obtained by myocardial contrast
echocardiography (MCE) using FS069 in these same patients.
Dr. Kaul reported no adverse effects were observed in patients
receiving FS069, reinforcing the high safety profile of this ultrasound
contrast agent even in the presence of dipyridamole, a potent
pharmacological stress agent which increases myocardial blood flow. The
concordance between nuclear perfusion imaging and FS069 MCE for the
presence or absence of abnormal perfusion was 92% (p<0.0001). Thus,
based on the data, FS069 stress MCE with harmonic imaging may provide at
least the same diagnostic accuracy as stress nuclear imaging. A larger
Phase 3 study will be conducted to more fully substantiate these
findings.
This study is the first demonstration in humans of the use of MCE
as a stress perfusion diagnostic technique compared with a validated and
accepted technique for myocardial perfusion. The study will be
submitted for publication in a major medical journal this Spring.
Currently, echocardiography does not provide blood flow (perfusion)
information. This new technique will provide simultaneous assessment of
both perfusion and function within the same myocardial region. If
confirmed, these results suggest that FS069 myocardial contrast
echocardiography has the potential to favorably compete with nuclear
imaging as a means of identifying regions of the heart receiving
inadequate blood supply.
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 businesses, 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 development of FS069 may differ materially
from the Company's expectations. Among the factors that could result in
a materially different outcome are the inherent uncertainties
accompanying new product development, actions of regulatory authorities
and the results of further trials, including the phase 3 study
contemplated.
# # #
MALLINCKRODT GROUP INC.
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: March 28, 1996
