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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): September 10, 1996
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
<PAGE>
Item 5. Other Events.
(a) In September 1996, Molecular Biosystems, Inc. (the "Company") entered
into a Settlement Agreement and Mutual Release (the "Agreement") with Shionogi &
Co., Ltd. ("Shionogi") pursuant to which the Company reacquired the right to
manufacture and sell the Company's proprietary first-generation contrast agent
for cardiac ultrasound imaging, ALBUNEX(R), its second-generation contrast
agent, FS069, and related products in the territory consisting of Japan, South
Korea and Taiwan. The Company had licensed these rights to Shionogi in March
1989.
The Company paid $3 million to Shionogi upon entering into the Agreement,
which became effective as of September 10, 1996, and agreed to pay a further
$5.5 million without interest in three annual installments, of which the first
two installments of $2 million each are payable in September 1997 and September
1998, respectively, and the third and final installment of $1.5 million is
payable in September 1999.
The Company and Shionogi also agreed to dismiss their respective claims
against one another which were the subject of arbitration proceedings pending
before the American Arbitration Association in New York, New York.
A copy of the Company's press release with respect to the Agreement is
attached as Exhibit 10.1.
(b) On October 18, 1996 the Company filed a pre-marketing approval
("PMA") application with the U.S. Food and Drug Administration for the Company's
second-generation contrast agent for cardiac ultrasound imaging, FS069, for use
in enhancing endocardial border definition and opacification of the left
ventricular chamber.
A copy of the Company's press release with respect to this filing is
attached as Exhibit 10.2.
<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: November 15, 1996.
Molecular Biosystems, Inc.
/s/Gerard A. Wills
By
Gerard A. Wills
Vice President, Finance
and Chief Financial Officer
<PAGE>
Exhibit Index
Sequentially
Exhibit Description Numbered Page
10.1 Press release (September 24, 1996) 5
10.2 Press release (October 18, 1996) 6
Exhibit 10.1
NEWS RELEASE
FOR IMMEDIATE RELEASE:
Molecular Biosystems, Inc.
Gerard A. Wills, Chief Financial Officer
Stepehen F. Keane, Director Investor Relations
(619) 824-2212
MOLECULAR BIOSYSTEMS, INC. ANNOUNCES
REPURCHASE OF FAR EAST DISTRIBUTION RIGHTS
San Diego, California, September 24, 1996 -Molecular Biosystems, Inc. (NYSE:MB)
(MBI) today announced that it has reacquired all rights to manufacture, market
and sell its ALBUNEX (R) family of products in the territory, consisting of
Japan, Taiwan and South Korea, formerly exclusively licensed to Shionogi & Co.
Ltd. of Osaka, Japan. This agreement settles an outstanding dispute between the
two companies concerning the license and distribution agreement for ALBUNEX(R).
The agreement results in the dismissal of all claims raised by MBI and SHIONOGI
against each other in the pending arbitration proceeding. Under the agreement,
MBI paid $3 million to Shionogi and will pay an additional $5.5 million over the
next three years.
Kenneth J. Widder, MBI's Chairman and Chief Executive Officer stated, "MBI is
pleased with the settlement of its dispute with Shionogi. The termination of
this relationship enables MBI to seek another company to distribute ALBUNEX(R)
and to diligently pursue the development of MBI's second-generation ultrasound
contrast agent, FS069, in the territories formerly licensed to Shionogi." Dr.
Widder added, "MBI is actively pursuing discussions with several promising
candidates to work with MBI in commercializing our products in this territory."
MBI, based in San Diego, California, is a world leader in the development of
ultrasound contrast agents for medical imagining. ALBUNEX(R) the first FDA
approved ultrasound imaging agent is currently marketed in the United States by
Mallinckrodt Medical, Inc. (Mallinckrodt Group Inc. NYSE:MKG). MBI shares are
listed on the New York Stock Exchange under the symbol "MB."
Exhibit 10.2
NEWS RELEASE
FOR IMMEDIATE RELEASE
Molecular Biosystems, Inc.
Gerard A. Wills, Chief Financial Officer
Stephen F. Keane, Director Investor Relations
(619) 824-2212
Mallinckrodt Group
Barbara Abbett, Vice President Communications (314) 854-5230
Peter Faur, Director, Corporate Communications (314) 854-5234
Cole Lannum, Director, Investor Relations (314) 854-5370
Molecular Biosystems and Mallinckrodt File A Pre-Marketing Approval
Application with the U.S. Food and Drug Administration for its Next
Generation Ultrasound Imaging Agent, FS069
San Diego, California and ST LOUIS, Missouri, October 18, 1996 -- Molecular
Biosystems, Inc. (NYSE:MB) (MBI) and Mallinckrodt Inc. (NYSE:MKG) jointly
announced today that they have filed a pre-marketing approval (PMA) application
with the U.S. Food and Drug Administration (FDA) for FS069, MBI's second
generation ultrasound imaging agent. FS069 is designed to enhance ultrasound
imaging by enabling physicians to visualize blood flow and enhance resolution of
anatomical structures in those patients with suboptimal non-contrast ultrasound
exams.
This submission involved studies for cardiac function focusing on enhancing
endocardial border delineation (EBD) and secondarily determining the ability of
the agent to opacify the left ventricular chamber (LVO). Additionally, Doppler
signal enhancement, which provides important information about blood flow in
cardiac valves and vessels, was also studied.
"We are very pleased to announce the submission of this PMA for FS069. The
filing marks the most important achievement for MBI in calendar year 1996," said
Kenneth J. Widder, M.D., Chairman and CEO of Molecular Biosystems. "MBI is the
only Company in the world which has been cleared by the FDA to market an
ultrasound imaging agent. We believe this experience is an important advantage
in what is promising to be a highly competitive field. The Company is currently
involved in additional clinical studies for FS069 including myocardial perfusion
and radiology imaging trials."
"We are pleased to continue in partnership with MBI as we both pursue approval
for FS069," said James C. Carlile, President of Mallinckrodt's Medical Imaging
Division. "Mallinckrodt is an established leader in a number of medical imaging
product lines. Our partnership with MBI and its ultrasound products helps us
better serve the overall imaging needs of healthcare professionals."
The phase 3 study submitted as part of the PMA comprised 203 patients from 14
leading US institutions in which FS069 was compared to ALBUNEX(R), MBI"s first
generation ultrasound contrast agent, marketed by Mallinckrodt. Results of the
trial demonstrated the superiority of FS069 to ALBUNEX(R) in providing
significant improvement of endocardial border delineation as well as left
ventricular contrast enhancement, thus enabling the visualization of regional
and global wall motion and function. Additionally, dosages as low as 0.2 ml of
FS069 significantly enhanced Doppler signals in these patients.
Comprehensive review of the previously disclosed test data demonstrated that
endocardial border delineation, primary endpoint of this study, improved in at
least one border segment to a diagnostic level in 93% of all patients after the
administration of 3.0 ml FS069. In addition, two-thirds or more filling of the
left ventricle was demonstrated at the 3.0 ml dose in 94.5% of all patients.
More importantly, of those patients with cardiac and/or pulmonary dysfunction, a
subgroup in whom first generation contrast agents may be less effective,
improvement in endocardial border delineation was seen in 93% and two-thirds or
greater left ventricular filling was seen in 94.1%.
FS069 is licensed to Mallinckrodt in North and South America, China, Australia,
and New Zealand. MBI developed and manufactures FS069 while Mallinckrodt is
responsible for sales and marketing. MBI is currently in advanced discussions
with a European partner and is actively pursuing discussions for its recently
reacquired Far East territories.
Molecular Biosystems, Inc., based in San Diego, California, is a leader in the
development of ultrasound contrast agents for medical imaging. ALBUNEX(R), the
first FDA approved ultrasound imaging agent is currently marketed in the United
States by Mallinckrodt Inc. MBI shares are listed on the New York Stock Exchange
under the symbol "MB."
Mallinckrodt (NYSE:MKG) 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.
This news release contains forward looking statements that involve risk and
uncertainties. The outcome of the submission may differ from the Company's
expectations. Among the factors that could result in a materially different
outcome are the actions of the regulatory authorities and uncertainties inherent
in the development of a new product.
