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
May 22, 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
<PAGE>
Item 5. Other Events
A press release was issued May 19, 1998. The relevant portion of the
text of that release was as follows:
(*) Indicates registered trademark
MOLECULAR BIOSYSTEMS AND MALLINCKRODT REPORT FINAL EUROPEAN APPROVAL
OF OPTISON(*)
Product is first-to-market in Europe; immediate launch planned
ST. LOUIS, Missouri, and SAN DIEGO, Calif., May 19, 1998 -
Mallinckrodt Inc. (NYSE:MKG) and Molecular Biosystems, Inc. (NYSE:MB)
("MBI") today announced that OPTISON(*), the world's first and only
commercially available next-generation cardiac ultrasound contrast
imaging agent, has received final marketing authorization by the
European Commission for use in patients with suspected or known
cardiovascular disease. The authorization covers all 15 member
states of the European Union.
OPTISON(*) is the only fluorocarbon-based agent approved for use
in Europe. Mallinckrodt plans to launch OPTISON(*) immediately in
Germany, Austria and the United Kingdom, followed by other European
member states pending certain pricing approvals. This initial launch
will target a significant portion of the total European market.
"We are pleased to be able to bring the benefits of OPTISON(*)
to European patients," said C. Ray Holman, chairman and chief
executive officer of Mallinckrodt. "OPTISON(*)" is being well received
in the United States, and we believe the European community will be
equally accepting of this exciting new tool for ultrasound cardiac
imaging."
OPTISON(*) has been available commercially in the United States
since January 1998 and is being used in nearly 500 U.S. hospitals and
cardiology group practices. MBI and Mallinckrodt attribute
OPTISON's(*) early success to (1) outstanding product efficacy; (2)
an excellent safety profile; (3) ease of use; and (4) exclusivity in
the marketplace. Cardiologists view the product as a significant
adjunct to their diagnostic capabilities in difficult to image
patients.
"The approval of OPTISON(*) in Europe gives us the distinction
of having, once again, the first and only product of its kind in a
large and growing market," remarked Bobba Venkatadri, president and
CEO of MBI. "OPTISON(*), with its impressive safety and efficacy
profile, is setting the gold standard for contrast agents in the
United States, and we expect no less in the European market."
Molecular Biosystems (NYSE: MB), based in San Diego, California,
is a world leader in the development and commercialization of
ultrasound contrast agents for diagnostic imaging. The company's
breakthrough product, OPTISON(*), enables improved diagnosis of heart
disease through clearer ultrasound images. Information about MBI may
be obtained via fax by calling 888-329-4007 (toll-free) or via the
internet by pointing your browser to (www.mobi.com).
Based in St. Louis, Mo., Mallinckrodt Inc. has three healthcare
product groups - Imaging, Pharmaceuticals and Respiratory. The
company operates in more than 100 countries and 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 risk and uncertainties. Among the factors that could result
in a materially difference outcome include: the failure of
OPTISON(*) to gain market acceptance in Europe or other markets, an
adverse result in MBI's and Mallinckrodt's pending patent lawsuits,
or an adverse ruling by the PTO in the pending patent reexaminations:
and other risk factors reported from time to time in MBI and
Mallinckrodt's filings with the Securities Exchange Commission.
Mallinckrodt Inc.
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: May 22, 1998
