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
April 23, 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 April 23, 1997. The relevant portion of
the text of that release was as follows:
(*) Indicates registered trademark.
MALLINCKRODT SUPPORTING MOLECULAR BIOSYSTEMS IN FS069 CASE
ST. LOUIS, Mo., April 23, 1997 - Mallinckrodt Inc. (NYSE:MKG)
announced today that it is supporting its business partner, Molecular
Biosystems, Inc. (MBI) (NYSE:MB) as MBI works through legal
challenges that are delaying final review and approval for MBI's
next-generation ultrasound imaging contrast agent, FS069.
"We believe that FS069 meets the requirements for review as a medical
device because it does not depend upon the metabolism of the body or
chemical action to accomplish its purposes," said C. Ray Holman,
chairman and chief executive officer of Mallinckrodt, which will be
the marketer of FS069. "It is unfortunate that legal challenges are
being used to keep patients from the benefits of FS069, which can
enhance ultrasound visualization of the heart by enabling physicians
to see blood flow and anatomical structure when ultrasound alone is
inadequate. We hope to see these issues resolved soon so that FS069
can receive final review and begin benefiting patients. We are
offering counsel, advice and support to MBI."
The legal challenges were instigated by three MBI competitors
who have their own ultrasound products now under review by the U. S.
Food and Drug Administration. The competitors' products are not as
far along in the review process as FS069, which was recommended in
February for clearance without conditions by an FDA advisory panel.
The challenges have resulted in the federal district court in
Washington, D. C., enjoining the FDA from proceeding on review and
market clearance for FS069 and the competitors' products until the
FDA responds to citizens' petitions filed earlier this year. The
petitions, also filed by MBI competitors, challenge the FDA's
decision to review FS069 as a medical device while reviewing the
competing products as drugs. MBI's first-generation ultrasound
product, ALBUNEX(*), received clearance as a device.
Late Tuesday, MBI filed a motion asking the district court to
reconsider its decision. In addition, MBI filed a second motion
asking the court to clarify whether it intended that all research
work on the various companies' products be halted while the FDA is
enjoined from review and clearance of the products. Mallinckrodt
fully supports these actions.
"We hope for a quick resolution of these matters," Holman said.
Mallinckrodt serves healthcare and specialty chemicals markets
worldwide. 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 1,000 products in more than 100 countries. The Mallinckrodt web
site address is (www.mallinckrodt.com).
# # #
Mallinckrodt Inc.
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: April 24, 1997
