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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): May 18, 1998
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)
10070 Barnes Canyon Road, San Diego, California 92121
(Address of principal executive offices)
Registrant's telephone number, including area code: (619) 812-7001
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Item 5. Other Events.
Final European Approval of OPTISONtm
On May 18, 1998, OPTISON, the Company's second-generation contrast
agent for cardiac ultrasound imaging, received final marketing authorization by
the European Agency for the Evaluation of Medicinal Products for use in patients
with suspected or known cardiovascular disease. The authorization covers all 15
member states of the European Union.
A copy of the press release that the Company jointly issued with
Mallinckrodt, Inc., on May 19, 1998, is attached to this Report as Exhibit 10.1.
Mallinckrodt, Inc., is the Company's marketing partner for OPTISON 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: May 22, 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 (May 19, 1998) 5
Exhibit 10.1
FOR IMMEDIATE RELEASE
Molecular Biosystems, Inc.
Robert P. Giargiari, Investor Relations (619) 812-7179
Patricia Sullivan, Corporate Communications (619) 812-7146
E-Mail: [email protected]
Mallinckrodt Inc.
Media Contacts: Barbara Abbett (314) 854-5230
Peter Faur (314) 654-5234
E-Mail: [email protected]
Investors Contacts: Barbara Gould (314) 654-3190
E-Mail: [email protected]
Molecular Biosystems and Mallinckrodt Report
Final European Approval of OPTISON(TM)
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(TM), 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
(http://www.mobi.com).
Based in St. Louis, Mo., Mallinckrodt Inc. has three healthcare
products: group-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(TM) 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.
