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
January 29, 1998
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.)
675 McDonnell Boulevard, St. Louis, MO 63134
(Address of principal executive offices) (ZIP Code)
Registrant's telephone number, (314) 654-2000
including area code
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Item 5. Other Events
A press release was issued January 29, 1998. The relevant portion of
the text of that release was as follows:
(*) Indicates registered trademark
OPTISON(*) RECOMMENDED FOR EUROPEAN APPROVAL; NEW ULTRASOUND IMAGING
AGENT WILL AID IN DETECTION OF CARDIAC DISEASE
ST. LOUIS, Mo., and San Diego, Calif., January 29, 1998 -
Mallinckrodt Inc. (NYSE:MKG) and Molecular Biosystems, Inc. (NYSE:MB)
(MBI) today announced that the European Union's Committee for
Proprietary Medicinal Products (CPMP) of the European Medicines
Evaluation Agency (EMEA) has recommended the approval of OPTISON(*),
a new ultrasound imaging agent developed to aid in the detection of
cardiac disease.
Bobba Venkatadri, president and chief executive officer of
Molecular Biosystems, said: "We are pleased that OPTISON(*) is once
again the first of the next generation ultrasound contrast agents
recommended for approval. We believe that OPTISON(*)s clearance in
the United States and now this recommendation in the European Union
reinforces the product's safety and efficacy. Our management team
has worked hard to obtain approval for OPTISON(*) in these two
territories and has succeeded in being first in this approval
process."
C. Ray Holman, chairman and chief executive officer of
Mallinckrodt, said: "OPTISON(*) is meeting with good early success
in the United States. Clinicians are finding that it enhances
suboptimal cardiac ultrasound images. We are looking forward to
marketing the product in Europe as well."
The regulatory file was submitted to the European Medicines
Evaluation Agency (EMEA) under the centralized procedure in which a
single license is granted for 15 member states of the European Union.
The marketing authorization is expected to be granted by the European
Commission within a few months. Upon EMEA approval, OPTISON(*) will
be launched by Mallinckrodt. OPTISON(*) received marketing clearance
from the U.S. Food and Drug Administration on December 31, 1997, and
is being distributed by Mallinckrodt in the United States.
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."
Based in St. Louis, Missouri, and operating globally in more
than 100 countries, Mallinckrodt Inc. had fiscal 1997 net sales of
$1.9 billion. The Mallinckrodt web site address is
(www.mallinckrodt.com).
# # #
This news release contains forward-looking statements that involve
risks and uncertainties. These statements are based on current
expectations; actual results may differ materially. Among the
factors that could cause actual results to differ materially are the
following: the impact of competitive products; market acceptance
issues, including the failure of new products to generate anticipated
sales levels; difficulties or delays in receiving required
governmental or regulatory approvals; and the other risk factors
reported from time to time in the Mallinckrodt's filings with the
Securities and Exchange Commission.
Mallinckrodt Inc.
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: January 30, 1998
