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 5, 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 January 5, 1998. The relevant portion of
the text of that release was as follows:
(*)Indicates registered trademark.
NEW ULTRASOUND IMAGING AGENT, OPTISON(*), CLEARED BY FDA; FIRST OF
THE NEW GENERATION ULTRASOUND AGENTS
ST. LOUIS, Mo., and San Diego, Calif., January 5, 1998 A new
cardiac ultrasound imaging agent, OPTISON(*), has received clearance
by the U. S. Food and Drug Administration for marketing in the United
States, Mallinckrodt Inc. (NYSE:MKG) and Molecular Biosystems, Inc.
(NYSE:MB) (MBI) announced today. Molecular Biosystems is the
developer and manufacturer of OPTISON(*), and Mallinckrodt will
market and distribute the product in the United States and most other
regions of the world.
In 1996, 11 million to 14 million cardiac ultrasound imaging
procedures were performed in the United States. Mallinckrodt and MBI
anticipate a significant opportunity for OPTISON(*), which is used to
enhance ultrasound cardiac images.
OPTISON(*), the first of the perfluorocarbon-containing
ultrasound agents to reach the market, enables physicians to enhance
resolution of anatomical structure where ultrasound alone is
inadequate. The product is specifically indicated for use in
patients with suboptimal echocardiograms to opacify the left
ventricle and to improve the delineation of the left ventricular
endocardial borders.
Ultrasound cardiac imaging has several advantages over other
imaging methods. It is minimally invasive, relatively inexpensive
and can provide a real-time image.
OPTISON(*) helps increase the effectiveness of echocardiography
in diagnosing heart disease by introducing gas-filled microspheres
into the blood. The microspheres travel in the bloodstream to the
left ventricle of the heart, where the microspheres reflect the
soundwaves generated from ultrasound equipment, enabling the
development of a clearer, more diagnostic ultrasound image. Overall,
the reported adverse events with Optison(*) were similar in type and
frequency to those reported with ALBUNEX(*), the first generation
ultrasound contrast agent.
Bobba Venkatadri, chief executive officer of Molecular
Biosystems, said: "We believe the product will significantly improve
many diagnoses of known or suspected heart disease patients.
Cardiovascular diseases remain America's Number One killer, causing a
death every 33 seconds."
C. Ray Holman, chairman and chief executive officer of
Mallinckrodt, said: "Mallinckrodt looks forward to marketing and
distributing OPTISON(*) in the United States and eventually in Europe
and other parts of the world. We believe this product will make
ultrasound imaging a stronger tool in the diagnosis of cardiac
disease, and we are excited to play a major role in bringing it to
patients."
Holman said Mallinckrodt is ready to begin marketing and
distributing OPTISON(*). Manufacturing can begin immediately at MBI.
The sales force is trained and prepared to sell, and distribution
channels are in place.
Eric Topol, M. D., Cardiology, Cleveland Clinic, said:
"OPTISON(*) will provide physicians with an important tool to assist
in imaging the left ventricle. Because this is the primary pumping
chamber of the heart, it is usually the first to display any damage
or abnormality from ischemic heart disease."
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." ALBUNEX(*), the first FDA-cleared ultrasound
imaging agent, is currently marketed in the United States by
Mallinckrodt.
Mallinckrodt Inc. serves healthcare and specialty chemicals
markets worldwide. The company has four major businesses -
pharmaceuticals, diagnostic imaging, respiratory care and specialty
chemicals. The St. Louis, Missouri-based company, with fiscal 1997
net adjusted sales of $1.9 billion, operates in more than 100
countries. 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 5, 1998
