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UNITED STATES
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
Date of Report (date of earliest event reported): December 31, 1997
MOLECULAR BIOSYSTEMS, INC.
(Exact name of registrant as specified in its charter)
Delaware 1-10546 36-30878632
(State or other juris- (Commission file (IRS employer
diction of incorporation) number) identification number)
10030 Barnes Canyon Road, San Diego, California 92121
(Address of principal executive offices)
Registrant's telephone number, including area code: (619) 452-0681
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Item 5. Other Events.
Approval of OPTISONtm by the FDA
On December 31, 1997, the Company's new drug application for OPTISONtm,
the Company's second-generation contrast agent for cardiac ultrasound imaging,
was approved by the United States Food and Drug Administration (the "FDA"). This
approval permits the marketing of OPTISONtm in the United States for use in
patients with suboptimal echocardiagrams to opacify the left ventricle and to
improve the delineation of the left ventricular endocardial borders.
A copy of the press release that the Company jointly issued with
Mallinckrodt, Inc., on January 5, 1998, is attached to this Report as Exhibit
10.1. Mallinckrodt, Inc., is the Company's marketing partner for OPTISONtm in
the United States and most other regions of the world.
<PAGE>
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date: January 20, 1998.
Molecular Biosystems, Inc.
By /s/ Gerard A. Wills
Gerard A. Wills
Vice President, Finance
and Chief Financial Officer
<PAGE>
Exhibit Index
Sequentially
Exhibit Description Numbered Page
10.1 Press release (January 5, 1998) 5
Exhibit 10.1
FOR IMMEDIATE RELEASE
Molecular Biosystems Contacts:
Gerard A. Wills, Chief Financial Officer (619) 824-2219
Stephen F. Keane, Investor Relations (619) 824-2248
Patricia Sullivan, Corporate Communications (619) 824-2262
Mallinckrodt Inc:
Media Contacts: Peter Faur, (314) 654-5234
Barbara Abbett, (314) 654-5230
E-mail: [email protected]
Investor Contacts: Doug McKinney, (314) 654-5264
Scott Johnsen, (314) 654-5295
E-mail: [email protected]
NEW ULTRASOUND IMAGING AGENT, OPTISON(TM), 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(TM), 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(TM).
Mallinckrodt will market and distribute the product in the United States
and most other regions of the world.
In 1996, 11-14 million cardiac ultrasound imaging procedures were
performed in the United States. Mallinckrodt and MBI anticipate a significant
opportunity for OPTISON(TM), which is used to enhance cardiac images generated
by ultrasound.
OPTISON(TM), 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 quickly
provide a real-time image.
OPTISON(TM) helps increase the effectiveness of echocardiography in
diagnosing heart disease by introducing gas-filled microspheres into the blood.
The microspheres travel in the blood stream to the left ventricle of the heart
where the microspheres reflect the soundwaves generated from ultrasound
equipment, enabling the development of a clearer, more descriptive ultrasound
image.
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(TM) in
the United States and eventually in Europe. 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(TM) . 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(TM)
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(R),
MBI's first and the only other 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 risk
and uncertainties. The commercialization of OPTISON may differ materially from
the Company's expectations. Among the factors that could result in a materially
different outcome 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; an adverse result in MBI's and Mallinckrodt's pending
patent lawsuit against, or future litigation with, Sonus Pharmaceutical, Inc.;
Nycomed Imaging AS; ImaRx Pharmaceutical Corp. and marketing partner DuPont
Merck; and Bracco International B.V., including potential injunctive relief
delaying or prohibiting the sale of OPTISON; the inherent uncertainty involved
in the development of any new product; and other risk factors reported from time
to time in MBI's filing with the Securities Exchange Commission.
