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Last updated on April 24, 2014 at 21:24 EDT

Covidien Announces New Source of Vital Medical Isotopes

February 17, 2010

WARSAW, Poland, February 17, 2010 /PRNewswire-FirstCall/ –

– Addition of Polish Research Reactor Helps With Worldwide Supply Shortage

Covidien (NYSE: COV), a leading global provider of healthcare products,
and the Institute of Atomic Energy in Poland (IAE POLATOM) today announced an
agreement to augment and further diversify Covidien’s supply of Molybdenum 99
(Mo 99) to produce the medical isotope Technetium 99m (Tc 99m).

Tc 99m is a vital medical isotope used in over 80 percent of all nuclear
medicine diagnostic and functional studies of organs and anatomical systems.
The information from these studies is used by many medical specialists
(including radiologists, nephrologists, oncologists and cardiologists) to
better diagnose and treat patients. More than 35 million nuclear medicine
procedures are performed worldwide each year, more than half in the United
States
.

Adding the IAE POLATOM’S Maria Research Reactor to Covidien’s global
supply chain is expected to help Covidien meet the needs of more than one
million additional patients in just the first six months after the reactor
begins supplying Mo 99.

“This is an historic agreement. It is the first time in decades that a
new reactor has been brought into the global supply chain for medical
isotopes,” said Timothy R. Wright, President, Pharmaceuticals, Covidien. “We
are excited that we will now be working together to provide more than a
million patients around the globe with access to a critical medical isotope
during this serious shortage.”

The announcement comes two days before the High Flux Reactor (HFR) in
Petten, the Netherlands, is scheduled to begin a six-month shutdown for
scheduled repairs. The remaining operating reactors supplying Covidien are
the BR2 reactor in Belgium, the Osiris reactor in France and the Safari
reactor in South Africa. Canada’s National Research Universal (NRU) reactor
has been shut down for repairs since May 2009. When operating, the HFR and
NRU reactors have typically provided approximately 65 percent of the world’s
supply of medical isotopes.

The Maria Research Reactor, located approximately 30 km southeast of
Warsaw, first operated from 1975 until 1985 when it was taken off line for a
complete redesign. It resumed normal operations in 1993. Maria is considered
to be a relatively new reactor, compared with the other five aging reactors
that supply most of the world’s medical isotopes.

Today’s announcement is the culmination of more than six months’
collaboration between Covidien and IAE POLATOM. Processing of Mo 99 produced
during a test irradiation at the Maria Research Reactor last week is
currently underway at our Petten facility. Tc 99m derived from the Mo 99
produced in Poland should be commercially available to help meet European
needs within 30 days. Approval from the U.S. Food and Drug Administration is
pending for use in the United States and from Health Canada for use in Canada.

“We are pleased to be cooperating with Covidien to use the scientific
advancements we have made here at the Institute of Atomic Energy and the
Maria Research Reactor to meet the healthcare needs of patients throughout
the world at such a critical time,” said Prof. Krzysztof Wieteska, Director
of IAE POLATOM.

The agreement is the most recent example of steps the Company has taken
to actively manage the current medical isotope shortage. Since early 2009,
Covidien has:

    - Actively supported additional Mo 99 production cycles and an increase
    in the number of targets at Belgium's BR2 reactor during the shutdown of
    the HFR in the Netherlands.

    - Increased the production of potential alternative, clinically
    appropriate medical isotopes, such as thallium Tl 201.

    - Communicated frequently and directly with nuclear medicine providers
    about the supply challenge, providing detailed monthly calendars
    projecting the availability of Tc 99m generators on a daily basis.

    - Published these calendars and supply updates on a public website:

http://www.covidien.com/Mo99supply.

    - Encouraged clinicians to be more efficient in scheduling procedures and
    ordering Tc 99m - based products to maximize the number of doses
    available to the greatest number of patients.

“This agreement with the IAE POLATOM will help us meet our short- and
long-term needs for Molybdenum 99,” said Wright. “We look forward to a
productive relationship for the benefit of patients around the world.”

NOTE TO MEDIA:

Covidien and IAE POLATOM will hold a press conference today beginning at
14:30 Central European Time (8:30 a.m. US ET) at the PAP Press Center in
Warsaw, Poland.

It will be webcast and can be accessed at:
http://www.covidien.com/Mo99supply, along with fact sheets, photos,
illustrations and other materials.

ABOUT THE INSTITUTE FOR ATOMIC ENERGY – IAE POLATOM

The Institute for Atomic Energy, IAE POLATOM, was formed in 1983 to
conduct ongoing research and development of nuclear energy and nuclear
techniques, including the development and marketing of pharmaceuticals and
diagnostic kits containing radioisotopes.

ABOUT THE MARIA RESEARCH REACTOR

The Maria Research Reactor is a 30 MW high flux reactor located on the
IAE campus just outside of Warsaw, Poland. It first operated from 1975 until
1985. Over the next eight years it underwent a complete redesign and
modernization. The reactor has been in continuous operation since it resumed
normal operations in 1993. For this reason it is considered to be a
relatively new reactor with an operating life extending beyond 2020.

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
2009 revenue of $10.7 billion, Covidien has 42,000 employees worldwide in
more than 60 countries, and its products are sold in over 140 countries.
Please visit http://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,
the possibility that the Maria Research Reactor may not be able to supply Mo
99 in a volume or form sufficient to meet our needs or at all, 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 payers and governmental organizations, intellectual property
rights disputes, complex and costly regulation, including healthcare fraud
and abuse regulations, 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, including legacy Tyco-related litigation, 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 or potential environmental
liabilities. These and other factors are identified and described in more
detail in our filings with the SEC. We disclaim any obligation to update
these forward-looking statements other than as required by law.

SOURCE Covidien


Source: newswire