ST. LOUIS, Mar 10, 2011 (BUSINESS WIRE) —
Covidien (NYSE: COV), a leading global provider of healthcare
products, today announced that the U.S. Food and Drug
Administration (FDA) has approved the use of molybdenum-99 (Mo-99)
derived from low-enriched uranium (LEU) in the production of
technetium-99m (Tc-99m) generators. Tc-99m is a medical isotope,
utilized in over 80% of all nuclear medicine studies, supplied to
hospitals and nuclear pharmacies by Covidien’s Mallinckrodt
business.
Tc-99m is produced when Mo-99 decays following uranium
irradiation. The approval by the FDA allows use of LEU-based Mo-99
supplied by South Africa’s NTP Radioisotopes, Ltd., a subsidiary of
the Nuclear Energy Corporation of South Africa, in Tc-99m generator
production at Covidien’s Maryland Heights, MO, manufacturing
facility.
Tc-99m is a critical medical isotope used in diagnostic and
functional studies of organs and anatomical systems. The
information from these studies is used by many medical specialists
(including radiologists, cardiologists, nephrologists and
oncologists) to better diagnose and treat patients. More than 30
million nuclear medicine procedures are performed worldwide each
year using Tc-99m, more than half in the United States.
“This FDA approval represents another step in our commitment to
move toward LEU conversion in the production of Mo-99 and Tc-99m,”
said Elaine Haynes, Vice President and General Manager, Imaging,
Americas.
In January, 2009, the Company launched a collaborative effort
with Babcock & Wilcox Technical Services Group (B&W) to
develop solution-based reactor technology for LEU-based medical
isotope production, a unique approach designed to provide an
efficient domestic supply source. The project combines Covidien’s
expertise in radiopharmaceutical production and global regulatory
approvals with B&W’s patented liquid phase nuclear technology.
Covidien is also developing plans for conversion of its Mo-99
processing facility in Petten, the Netherlands, to facilitate use
of LEU.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that
creates innovative medical solutions for better patient outcomes
and delivers value through clinical leadership and excellence.
Covidien manufactures, distributes and services a diverse range of
industry-leading product lines in three segments: Medical Devices,
Pharmaceuticals and Medical Supplies. With 2010 revenue of $10.4
billion, Covidien has approximately 42,000 employees worldwide in
more than 60 countries, and its products are sold in over 140
countries. Please visit
www.covidien.com to learn more about our business.
Forward Looking Statements
Any statements contained in this communication that do not
describe historical facts may constitute forward-looking statements
as that term is defined in the Private Securities Litigation Reform
Act of 1995. Any forward-looking statements contained herein are
based on our management’s current beliefs and expectations, but are
subject to a number of risks, uncertainties and changes in
circumstances, which may cause actual results or Company actions to
differ materially from what is expressed or implied by these
statements. The factors that could cause actual future results to
differ materially from current expectations include, but are not
limited to, our ability to effectively introduce and market new
products or keep pace with advances in technology, the
reimbursement practices of a small number of large public and
private insurers, cost-containment efforts of customers, purchasing
groups, third-party payors and governmental organizations,
intellectual property rights disputes, complex and costly
regulation, including healthcare fraud and abuse regulations and
the Foreign Corrupt Practices Act, manufacturing or supply chain
problems or disruptions, rising commodity costs, recalls or safety
alerts and negative publicity relating to Covidien or its products,
product liability losses and other litigation liability,
divestitures of some of our businesses or product lines, our
ability to execute strategic acquisitions of, investments in or
alliances with other companies and businesses, competition, risks
associated with doing business outside of the United States,
foreign currency exchange rates and environmental remediation
costs. These and other factors are identified and described in more
detail in our Annual Report on Form 10-K for the fiscal year ended
September 24, 2010, and in subsequent filings with the SEC. We
disclaim any obligation to update these forward-looking statements
other than as required by law.
