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
May 16, 2000
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
Two press releases were issued May 8, 2000. The relevant portion of
the text of the first release was as follows.
(*) Indicates registered trademark
NYCOMED AMERSHAM, MALLINCKRODT AGREE ON ULTRASOUND PATENT SETTLEMENT,
ANNOUNCE JOINT DEVELOPMENT OF EXISTING ULTRASOUND PRODUCTS
Buckinghamshire, England, and St. Louis, Missouri, USA, May 8, 2000
Nycomed Amersham plc (LSE:NAM and NYSE:NYE) and Mallinckrodt Inc.
(NYSE:MKG) announced today that a major intellectual property
settlement has been agreed to by the two companies; Molecular
Biosystems Inc. (NYSE:MB), Mallinckrodt's ultrasound contrast product
development partner; and SONUS Pharmaceuticals Inc. (Nasdaq:SNUS).
The agreement covers all markets around the world with the
exception of the Pacific Rim and resolves key intellectual property
disputes among the parties, including ultrasound bubble composition.
Under terms of the settlement, Nycomed Amersham will receive from
Mallinckrodt a US$10m up-front license fee as well as royalties of an
undisclosed amount on future ultrasound contrast product sales.
Nycomed Amersham will also receive immediate joint access to
OPTISON(*), the ultrasound contrast agent currently marketed by
Mallinckrodt for diagnosis of cardiac wall abnormalities. The two
companies have also agreed to collaborate on further joint
development and commercialization of Mallinckrodt's OPTISON and of
Nycomed Amersham's SONAZOID. In return, Nycomed Amersham grants
Mallinckrodt a non-exclusive license under the Nycomed and SONUS
patents and Mallinckrodt and Molecular Biosystems grant Nycomed
Amersham and SONUS the right to practice under their patents.
Nycomed Amersham Chief Executive Bill Castell, said, "The multi-
party settlement brings to an end significant litigation, confirms the
strength of our ultrasound intellectual property and provides clarity
to the key claims required to practice in the field. We are pleased
to be working with Mallinckrodt in the co-promotion and future
development of OPTISON alongside our own product SONAZOID, currently
undergoing regulatory review in Europe and the United States. By
combining our efforts, we maximize the opportunities in this
potentially large market. Co-promotion of OPTISON allows Nycomed
Amersham immediate entry into the ultrasound market."
Mallinckrodt Chairman and Chief Executive Officer Ray Holman,
said, "We are delighted to have this litigation resolved and to now be
partnering with Nycomed Amersham in the ultrasound field as we seek to
develop additional cardiology and radiology indications beyond those
existing today. Our two companies have already made major investments
to develop the ultrasound contrast field and recognize that future
development efforts designed to enhance the utility of ultrasound as a
diagnostic tool can be best served by our sharing in the risks as well
as the opportunities that exist for this important modality. The
settlement and linked collaboration reaffirm the commitment our two
companies have to bring innovative products to the market that will
help to improve healthcare for patients worldwide. This business
model is extremely appropriate and desirable in today's environment of
complex regulatory issues and increasing healthcare costs and needs."
Nycomed Amersham plc is a world leader in in-vivo diagnostic
imaging and in life sciences. The company has annual sales of GBP 1.3
billion and around 8,500 employees worldwide. For further
information, visit our website at www.nycomed-amersham.com.
Mallinckrodt Inc. is a global manufacturer and marketer of
specialty medical products designed to sustain breathing, diagnose
disease and relieve pain. Named one of America's most admired medical
products and equipment companies by Fortune magazine, Mallinckrodt
does business in more than 100 countries. In fiscal 1999, combined net
sales were $2.6 billion for Mallinckrodt's respiratory, imaging and
pharmaceutical product lines. Based in St. Louis, Missouri,
Mallinckrodt's website 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 from those
projected are the following: the effect of business and economic
conditions; the impact of competitive products and continued pressure
on prices realized by the company for its products; constraints on
supplies of raw materials used in manufacturing certain of the
company's products; capacity constraints limiting the production of
certain products; difficulties or delays in the development,
production, testing, and marketing of products; difficulties or delays
in receiving required governmental or regulatory approvals; market
acceptance issues including the failure of products to generate
anticipated sales levels; difficulties in rationalizing acquired
businesses and in realizing related cost savings and other benefits;
the effects of and changes in trade, monetary and fiscal policies,
laws and regulations; foreign exchange rates and fluctuations in those
rates; the costs and effects of legal and administrative proceedings,
including environmental proceedings and patent disputes involving the
company; and the risk factors reported from time to time in the
company's SEC reports. The company undertakes no obligation to update
any forward-looking statements as a result of future events or
developments.
# # #
The relevant portion of the text of the second release was as follows.
MOLECULAR BIOSYSTEMS, MALLINCKRODT ANNOUNCE
RESTRUCTURING OF OPTISON(*) AGREEMENT
ST. LOUIS, Mo., and SAN DIEGO, Calif. -- May 8, 2000 -- Molecular
Biosystems, Inc. (OTCBB:MBIO) and Mallinckrodt Inc. (NYSE:MKG)
announced today the restructuring of their agreement concerning
OPTISON(*), the only U.S. Food and Drug Administration-approved
intravenous ultrasound contrast agent. Under the terms of the
agreement, Mallinckrodt will assume full control of the OPTISON
business, including responsibility for intellectual property disputes,
clinical development, manufacturing and real estate.
The announcement about the restructured agreement between
Molecular Biosystems and Mallinckrodt follows an earlier news release
on Monday that a settlement had been reached in three ongoing patent
disputes in Washington, DC, Seattle, WA, and Europe between Nycomed
Amersham plc (LSE:NAM; NYSE:NYE), Mallinckrodt, Molecular Biosystems
(MBI) and SONUS Pharmaceuticals Inc. (Nasdaq:SNUS). In addition,
Nycomed and Mallinckrodt announced the formation of an alliance in the
ultrasound business for the development and marketing of ultrasound
contrast agents, starting with OPTISON.
As a result of Molecular Biosystems and Mallinckrodt's
restructured agreement, MBI will receive an ongoing royalty of 5
percent on sales of ultrasound contrast agents by Mallinckrodt and
Nycomed in the Mallinckrodt territory, which is worldwide, excluding
Japan, South Korea and Taiwan. In addition, MBI will pay a total of
$7 million to Mallinckrodt as part of the intellectual property
settlement, $3 million of which will be paid initially.
Chugai Pharmaceuticals, one of the six largest pharmaceutical
companies in Japan, is MBI's partner for Japan, South Korea and
Taiwan. Japan is estimated to be the second largest market for
contrast agents in the world. Chugai recently initiated Phase III
studies for both the myocardial perfusion indication and for liver
imaging, the latter regarded by independent experts as the primary
opportunity in Japan. MBI receives a 28 percent royalty plus certain
milestone payments from Chugai and has no manufacturing or clinical
development responsibilities.
Molecular Biosystems' Chief Executive Officer Bobba Venkatadri,
commented, "It was necessary to restructure our agreement with
Mallinckrodt at this time to limit our current expenses and ensure the
potential for future shareholder value. It was a very difficult
decision. However, because of the slow ramp-up of OPTISON sales in
the U.S. and Europe and escalating legal expenses to Molecular
Biosystems (in excess of 40% of MBI's current expenses), management
and the Board of Directors determined that it was in the best interest
of the shareholders to take this action. We are pleased that OPTISON
will be co-promoted by two world leaders in the contrast media
business and look forward to the financial benefit of this new
alliance. With the new agreement, MBI can focus its efforts going
forward on assisting Chugai with its development of FS069 and can also
pursue several strategic alternatives with regard to corporate
development which now become available to us."
Mallinckrodt Imaging Group President Bradley J. Fercho said,
"Mallinckrodt's restructured agreement with Molecular Biosystems,
coupled with our agreement with Nycomed Amersham, provide exciting
opportunities for enhancing the development of additional cardiology
and radiology indications beyond those existing today in the
ultrasound field. We have made major investments to develop the
ultrasound field and to enhance the utility of ultrasound as a
diagnostic tool and are excited about the potential for the future.
The plans for making the transition in our working relationship with
Molecular Biosystems will be completed in the near future."
MBI, based in San Diego, California, is a world leader in
developing contrast agents for diagnostic imaging. Its innovative
product, OPTISON, enables improved diagnosis of heart disease through
clearer ultrasound images.
Mallinckrodt Inc. is a global manufacturer and marketer of
specialty medical products designed to sustain breathing, diagnose
disease and relieve pain. Named one of America's most admired medical
products and equipment companies by Fortune magazine, Mallinckrodt
does business in more than 100 countries. In fiscal 1999, combined
net sales were $2.6 billion for Mallinckrodt's respiratory, imaging
and pharmaceutical product lines. Based in St. Louis, Missouri,
Mallinckrodt's website 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 from those
projected are the following: the effect of business and economic
conditions; the impact of competitive products and continued pressure
on prices realized by the company for its products; constraints on
supplies of raw materials used in manufacturing certain of the
company's products; capacity constraints limiting the production of
certain products; difficulties or delays in the development,
production, testing, and marketing of products; difficulties or delays
in receiving required governmental or regulatory approvals; market
acceptance issues, including the failure of products to generate
anticipated sales levels; difficulties in rationalizing acquired
businesses and in realizing related cost savings and other benefits;
the effects of and changes in trade, monetary and fiscal policies,
laws and regulations; foreign exchange rates and fluctuations in those
rates; the costs and effects of legal and administrative proceedings,
including environmental proceedings and patent disputes involving the
company; difficulties or delays in addressing "Year 2000" problems in
the company's operations, or the inability of a major supplier or
customer to continue operations due to such problems; and the risk
factors reported from time to time in the company's SEC reports. The
company undertakes no obligation to update any forward-looking
statements as a result of future events or developments.
# # #
Mallinckrodt Inc.
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: May 16, 2000
