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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 to 15(d) of the Securities Exchange Act of 1934
Date of Report (date of earliest event reported): April 21, 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
<PAGE>
Item 5. Other Events.
(1) Stay of Action by the FDA
On April 21, 1997, United States District Judge Paul L. Friedman of the
United States District Court for the District of Columbia entered an order
enjoining the United States Food and Drug Administration (the "FDA") from
continuing any approval or review procedures relating to the Company's
pre-market approval application ("PMA") for FS069, the Company's
second-generation contrast agent for cardiac ultrasound imaging, until 10 days
after the FDA resolves the merits of citizen petitions previously filed with the
FDA by plaintiffs, Bracco Diagnostics, Inc., DuPont Merck Pharmaceutical
Company, ImaRx Pharmaceutical Corp. and Sonus Pharmaceuticals, Inc. These
citizen petitions requested the FDA to regulate all ultrasound imaging contrast
agents either as drugs (as the plaintiffs' contrast agents under development are
currently classified) or as medical devices (as the Company's ALBUNEX(R) and
FS069 are currently classified). On February 24, 1997, the FDA's advisory
Radiological Devices Panel had recommended approval of the Company' PMA for
FS069.
As described in Judge Friedman's opinion accompanying his order, the
purpose of the order is to grant "a limited injunction to preserve the status
quo pending a decision by the FDA as to how to treat all ultrasound contrast
agents, whether as medical devices or as drugs, or to provide a rational
explanation for the different treatment of the products at issue." Judge
Friedman's order thus identically enjoins the FDA from continuing any approval
or review procedures relating to any of the plaintiffs' respective products
until 10 days after the FDA resolves the merits of the plaintiffs' citizens
petitions.
A copy of the Company's press release with respect to the stay of action by
the FDA is attached to this Report as Exhibit 10.1.
(2) Brand Name Announced for FS069
On May 7, 1997, the Company and Mallinckrodt, Inc., jointly announced that
if and when approved for sale by the FDA, FS069 will be marketed in the United
States under the brand name, "OPTISON(TM)." Mallinckrodt, Inc. is the Company's
licensee for marketing and distributing ALBUNEX(R) and OPTISON(TM) throughout
the world (except for Japan, Korea and Taiwan).
A copy of Mallinckrodt's press release with respect to the brand name for
FS069 is attached to this Report as Exhibit 10.2.
(3) Patent Matters
The Company has become aware of several United States patents issued to
other companies covering various attributes of perfluorocarbon-containing
imaging agents such as OPTISON(TM). Certain of these companies also are pursuing
foreign patent protection. Some of these companies are developing or may be
developing ultrasound contrast imaging agents that would compete with
OPTISON(TM).
The patents and patent applications of these other companies involve a
number of complex legal and factual issues that are currently unresolved. The
Company believes that there may be a substantial overlap among many of the
claims in their patents and that it is likely that there will be administrative
proceeding or litigation in the United States and abroad to adjudicate their
conflicting rights. The Company believes that it could become a party to one or
more of these actions, which could take several years to conclude and could
result in a substantial cost to the Company.
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The Company believes that, for a variety of reasons, its commercialization
of OPTISON(TM) will not infringe any valid patent held by one of these other
companies. Depending upon the particular patent claim, these reasons include (i)
differences between OPTISON(TM) and the subject of the claim, (ii) the
invalidity of the claim due to the existence of prior art, (iii) the inadequacy
of the claim's specifications and (iv) lack of enablement. The Company intends
to challenge the validity of any such patent granted to one of the other
companies if the patent is asserted against the Company, and the Company will
enforce its own patents if any product of one of the other companies infringes
the Company's patent claims.
If any patent granted to one of the other companies is asserted against the
Company, litigation or administrative proceedings may be necessary to defend the
Company against infringement claims or to determine the priority, scope and
validity of the other company's proprietary rights. Any such litigation or
administrative proceedings could result in a substantial cost to the Company;
and given the complexity of the legal and factual issues, the inherent
vicissitudes and uncertainty of litigation, and other factors, there can be no
assurance of a favorable outcome. An unfavorable outcome could have a material
adverse effect on the Company's business, financial condition and results of
operations. Moreover, there can be no assurance that, in the event of an
unfavorable outcome, the Company would be able to obtain a license to any
proprietary rights that may be necessary to commercialize OPTISON(TM), either on
acceptable terms or at all. If the Company were required to obtain a license
necessary to commercialize OPTISON(TM), the Company's failure or inability to do
so would have a material adverse effect on the Company's business, financial
condition and results of operations.
<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 9, 1997
Molecular Biosystems, Inc.
By /s/ Gerard A. Wills
Gerard A. Wills
Vice President, Finance
and Chief Financial Officer
<PAGE>
Exhibit Index
Sequentially
Numbered
Exhibit Description Page
10.1 Press release (April 22, 1997) 6
10.2 Press release (May 7, 1997) 8
<PAGE>
Exhibit 10.1
News Release
FOR IMMEDIATE RELEASE
Molecular Biosystems, Inc.
Gerard A. Wills, Chief Financial Officer (619) 824-2219
Stephen F. Keane, Investor Relations (619) 824-2212
US District Court Imposes Status Quo on FDA
San Diego, California April 22, 1997--Molecular Biosystems, Inc.
(NYSE:MB) (MBI) responded to the District Court ruling on complaints filed on
April 14, 1997 by DuPont Merck Pharmaceutical, Inc., ImaRx Pharmaceutical Corp.,
Bracco Diagnostics, Inc., and Sonus Pharmaceuticals, Inc. against the United
States Food and Drug Administration ("FDA") seeking to compel the FDA to halt
action on MBI's Pre Marketing Approval Application for FS069. District Court
Judge Paul L. Friedman ordered the FDA to preserve the status quo pending FDA
action on Citizens' Petitions filed with the FDA by the plaintiffs. On February
24, 1997, the Radiology Device Advisory Panel of the FDA voted to recommend
approval of FS069 without conditions.
The Court's preliminary injunction bars the FDA from approving MBI's
second-generation contrast agent, FS069 and from proceeding with any approval or
review proceedings relating to any of the plaintiffs' products until 10 days
after the FDA has responded to Citizens' Petitions previously filed with the FDA
by the plaintiffs. The Citizens' Petitions seek FDA action to regulate
ultrasound contrast agents under development by the plaintiffs and MBI
consistently. Presently, MBI is the only company with an approved ultrasound
contrast product, ALBUNEX(R), which is regulated as a medical device. Products
under development by the petitioners are currently regulated as drugs.
The Court Order concluded that the public interest would be "...served
by the grant of a limited injunction to preserve the status quo pending a
decision by the FDA as to how to treat all ultrasound contrast agents, whether
as medical devices or as drugs, or to provide a rational explanation for it's
different treatment of the product as issue here."
Kenneth J. Widder, Molecular Biosystems, chairman and chief executive
officer stated, "We are disappointed that the Court has issued this ruling. We
note, however, that the Court sought to maintain an even playing field by
enjoining the FDA from proceeding with any approval or review proceedings
relating to our competitors' products. MBI believes that the FDA has acted
correctly in regulating both FS069 and its predecessor product, ALBUNEX(R), as
medical devices. It is unfortunate that the plaintiffs in these court
proceedings seem more interested in delaying the approval of FS069 for
competitive reasons than in the interests of patients who would potentially
benefit from the use of this important new imaging agent. MBI's Pre Marketing
Approval Application demonstrates the safety and efficacy of FS069 under highly
rigorous testing--the same requirements under which the FDA approved ALBUNEX(R),
our pioneering ultrasound contrast agent, which has been safely used in over
twenty-five thousand patients."
MBI, Inc., based in San Diego, California, is a world leader in the
development and manufacture of ultrasound contrast devices for medical imaging.
MBI shares are listed on the New York Stock Exchange under the symbol "MB".
ALBUNEX(R), the first FDA approved ultrasound imaging agent, is currently
marketed in the United States by Mallinckrodt Inc.( NYSE:MKG). This news release
contains forward looking statements that involve risks and uncertainties. The
company's successful commercialization of FS069 may differ materially from the
company's expectations. Among the factors that could result in a materially
different outcome are the FDA's decision on the Citizens' Petitions, further
review and ruling by the District Court, the actions of regulatory agencies, and
the inherent uncertainty involved in the development of any new product.
<PAGE>
Exhibit 10.2
News Release
Brand Name Chosen for Proposed Ultrasound Imaging Agent FS069
ST. LOUIS, May 7 /PRNewswire/ -- Mallinckrodt Inc. (NYSE: MKG) and
Molecular Biosystems, Inc. (NYSE: MB) (MBI) jointly announced today that
OPTISON(TM) will be the U.S. brand name for FS069, MBI's second generation
ultrasound contrast agent. OPTISON(TM), which is awaiting clearance by the U.S.
Food and Drug Administration, will be marketed by Mallinckrodt. It is designed
to enhance ultrasound imaging by enabling physicians to visualize blood flow and
enhance resolution of anatomical structure where ultrasound alone is inadequate.
OPTISON(TM) is specifically proposed for use in the assessment of cardiac
function, which includes the visualization of endocardial borders and left
ventricular opacification.
James C. Carlile, president of Mallinckrodt's Medical Imaging Division,
said: "Mallinckrodt looks forward to marketing and distributing FS069 in the
United States and Europe as OPTISON(TM). We are proud to have OPTISON(TM) join
our growing family of image-enhancing agents, which also includes OPTIRAY(R),
our premier product in the area of X-ray contrast media." 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), the first FDA-cleared
ultrasound imaging agent, is currently marketed in the United States by
Mallinckrodt. Mallinckrodt serves healthcare and specialty chemicals markets
worldwide. The company is a major producer of diagnostic imaging agent, 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 1,000 products in more than 100
countries. The Mallinckrodt web site address is http://www.mallinckrodt.com.
This news release contains forward-looking statements that involve risks and
uncertainties. The approval and commercialization of OPTISON(TM) may differ
materially from the companies' expectations. Among the factors that could result
in a materially different outcome are the actions of regulatory agencies, the
success of marketing efforts and the inherent uncertainty involved in the
development of any new product.
SOURCE Mallinckrodt, Inc.
