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
April 27, 1999
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
A press release was issued April 27, 1999. The relevant portion of
the text of that release was as follows:
(*) Indicates registered trademark
MOLECULAR BIOSYSTEMS TRANSFERS OPTISON(*)
MANUFACTURING TO MALLINCKRODT
Amended Agreement Emphasizes Strengths of Both Companies; MBI To
Focus on Product Development, Mallinckrodt To Market and Manufacture
OPTISON
San Diego, California, and St. Louis, Missouri, April 27, 1999 -
Molecular Biosystems, Inc. (NYSE: MB) and Mallinckrodt Inc. (NYSE:
MKG) announced today their agreement to transfer the manufacture of
OPTISON, the only advanced generation cardiac ultrasound imaging
agent commercially available in the United States and Europe, from
MBI to Mallinckrodt under an amendment to their existing research
support and distribution agreement.
In addition to the transfer of manufacturing, the amended agreement
extends Mallinckrodt's responsibility for funding clinical trials to
include all cardiology, as well as radiology, clinical trials for
OPTISON in the United States. Under the amended agreement, MBI will
continue to conduct all cardiology trials for OPTISON and will assume
responsibility for conducting radiology trials in the United States.
Bradley J. Fercho, president of Mallinckrodt's Imaging Group, and
Bobba Venkatadri, MBI president and chief executive officer,
emphasized that the amended agreement will capitalize on each
company's key strengths and is expected to be financially rewarding
for both companies.
"MBI expects to significantly reduce its expenses as a result of
Mallinckrodt's agreement to manufacture OPTISON and contribute more
to clinical trial expenses," Venkatadri, said. "This realignment
enables both companies to concentrate on what each company does best,
and will help us to conserve our cash for our long-term growth
strategy. We will focus on expanding OPTISON labeling for new
indications and aggressively pursue the development of MB-840, our
liver-specific CT imaging agent. Equally important, we are confident
that the proven manufacturing capabilities at Mallinckrodt will help
OPTISON continue to develop and penetrate the ultrasound contrast
market, estimated to be approximately $1 billion within five to seven
years."
Fercho said, "The amended agreement will draw on the proven
manufacturing expertise at Mallinckrodt and will allow MBI to focus
on its core strengths in product development."
Under the terms of the amended agreement, which is retroactive to
March 1, 1999, Mallinckrodt will reimburse MBI for all manufacturing
expenses, including incremental costs related to the technology
transfer. In exchange for the transfer of manufacturing and
increased financial support of clinical trials for OPTISON, MBI will
receive a reduced royalty rate on product sales of OPTISON.
Developed by MBI and marketed in the United States and Europe by
Mallinckrodt, OPTISON is used in more than 1,600 hospitals and
cardiology group practices in the United States, Germany, Spain and
the United Kingdom.
Molecular Biosystems, based in San Diego, California, is a world
leader in developing contrast agents for diagnostic imaging. The
company's innovative product, OPTISON, enables improved diagnosis of
heart disease through clearer ultrasound images.
Based in St. Louis, Missouri, Mallinckrodt has three healthcare
product groups - Imaging, Pharmaceuticals and Respiratory. The
company operates in more than 100 countries and had fiscal 1998 sales
of $2.4 billion.
This news release contains forward-looking statements that involve
risks and uncertainties. Among the factors that could result in a
materially different outcome are: the failure of OPTISON to gain
market acceptance either in the U.S. 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;
delays and expenses incurred in establishing OPTISON manufacturing at
Mallinckrodt's facility and other risk factors reported from time to
time in MBI's and Mallinckrodt's filings with the Securities and
Exchange Commission.
For More Information on Molecular Biosystems by Fax, Dial
888-329-4007, or Visit its Website: www.mobi.com
For More Information on Mallinckrodt, Visit its Website:
www.mallinckrodt.com
# # #
Mallinckrodt Inc.
/s/ Roger A. Keller
- --------------------------
ROGER A. KELLER
Vice President, Secretary
and General Counsel
DATE: April 27, 1999
