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
December 9, 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
Item 5. Other Events
A press release was issued December 9, 1996. The relevant portion of
the text of that release was as follows:
(*) Indicates registered trademark.
GastroMARK(*) Imaging Agent Cleared for Marketing in U.S.
ST. LOUIS, Mo. and Cambridge, Mass., December 9, 1996 -- Advanced
Magnetics, Inc.(AMEX:AVM) and Mallinckrodt Inc. (NYSE:MKG) today
announced that GastroMARK, a contrast agent for use with magnetic
resonance imaging (MRI) of the gastrointestinal tract, has been
cleared for marketing in the United States. GastroMARK, the first
superparamagnetic oral MRI contrast agent to be marketed in the
United States, will be used to mark the bowel and distinguish the
bowel from adjacent abdominal structures and from areas of suspected
pathology.
"This has been a significant year in the history of Advanced
Magnetics," stated Jerome Goldstein, president and CEO of Advanced
Magnetics. "With our second U.S. marketing clearance this year, the
company is emerging from the development stage to commercialization.
We are already working with Mallinckrodt to ensure the successful
launch of GastroMARK." Additionally, Advanced Magnetics' liver
contrast agent, Feridex I.V.(*) was also cleared for marketing in the
United States this year.
"We are delighted to be able to add GastroMARK to our line of
medical imaging products," stated James C. Carlile, president of
Mallinckrodt's Medical Imaging Division. "We believe magnetic
resonance imaging will continue to grow as an important imaging
technology,and we intend to offer more products to serve the MRI
market."
The clearance of GastroMARK triggers a milestone payment from
Mallinckrodt to Advanced Magnetics. Mallinckrodt will market the
product in the United States, Canada and Mexico with rights in
additional territories. GastroMARK was approved earlier this year in
Canada.
"GastroMARK is particularly effective because it darkens the
bowel in the MR image which is easier to read than other currently
available MR and CT contrast agents in which the bowel is
brightened," stated Pablo Ros, M.D. F.A.C.R. and associate chairman,
Department of Radiology, Magnetic Resonance Imaging, Shands Hospital,
University of Florida College of Medicine.
The safety and efficacy of GastroMARK was evaluated in clinical
trials conducted in the United States. The most frequently reported
adverse events were diarrhea and flatulence; a large number of
patients also reported these events prior to ingestion of GastroMARK.
GastroMARK has also been cleared for marketing in western
Europe, under the brand name Lumirem(*). It is being marketed in
Europe by Guerbet S.A. of France.
Advanced Magnetics, Inc. is a pharmaceutical company involved in
the development and manufacture of MRI contrast agents for the
diagnosis of cancer and other diseases as well as the development of
targeted therapeutics for the treatment of liver diseases and other
organ-specific diseases.
Mallinckrodt 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>.
Any statements which are not historical facts contained in this press
release are forward-looking statements that involve risks and
uncertainties, including but not limited to, those relating to the
timing of the marketing launch of GastroMARK, the market acceptance
of GastroMARK, and other risks identified in Advanced Magnetics,
Inc.'s Securities and Exchange Commission filings.
# # #
Mallinckrodt Inc.
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: December 12, 1996
