Covidien Announces New Source of Vital Medical Isotopes
- 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 anagreement 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 nuclearmedicine 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) tobetter diagnose and treat patients. More than 35 million nuclear medicineprocedures are performed worldwide each year, more than half in the UnitedStates.
Adding the IAE POLATOM'S Maria Research Reactor to Covidien's globalsupply chain is expected to help Covidien meet the needs of more than onemillion additional patients in just the first six months after the reactorbegins supplying Mo 99.
"This is an historic agreement. It is the first time in decades that anew reactor has been brought into the global supply chain for medicalisotopes," said Timothy R. Wright, President, Pharmaceuticals, Covidien. "Weare excited that we will now be working together to provide more than amillion patients around the globe with access to a critical medical isotopeduring this serious shortage."
The announcement comes two days before the High Flux Reactor (HFR) inPetten, the Netherlands, is scheduled to begin a six-month shutdown forscheduled repairs. The remaining operating reactors supplying Covidien arethe BR2 reactor in Belgium, the Osiris reactor in France and the Safarireactor in South Africa. Canada's National Research Universal (NRU) reactorhas been shut down for repairs since May 2009. When operating, the HFR andNRU reactors have typically provided approximately 65 percent of the world'ssupply of medical isotopes.
The Maria Research Reactor, located approximately 30 km southeast ofWarsaw, first operated from 1975 until 1985 when it was taken off line for acomplete redesign. It resumed normal operations in 1993. Maria is consideredto be a relatively new reactor, compared with the other five aging reactorsthat 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 producedduring a test irradiation at the Maria Research Reactor last week iscurrently underway at our Petten facility. Tc 99m derived from the Mo 99produced in Poland should be commercially available to help meet Europeanneeds within 30 days. Approval from the U.S. Food and Drug Administration ispending 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 scientificadvancements we have made here at the Institute of Atomic Energy and theMaria Research Reactor to meet the healthcare needs of patients throughoutthe world at such a critical time," said Prof. Krzysztof Wieteska, Directorof IAE POLATOM.
The agreement is the most recent example of steps the Company has takento actively manage the current medical isotope shortage. Since early 2009,Covidien has:
"This agreement with the IAE POLATOM will help us meet our short- andlong-term needs for Molybdenum 99," said Wright. "We look forward to aproductive relationship for the benefit of patients around the world."
NOTE TO MEDIA:
Covidien and IAE POLATOM will hold a press conference today beginning at14:30 Central European Time (8:30 a.m. US ET) at the PAP Press Center inWarsaw, 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 toconduct ongoing research and development of nuclear energy and nucleartechniques, including the development and marketing of pharmaceuticals anddiagnostic kits containing radioisotopes.
ABOUT THE MARIA RESEARCH REACTOR
The Maria Research Reactor is a 30 MW high flux reactor located on theIAE campus just outside of Warsaw, Poland. It first operated from 1975 until1985. Over the next eight years it underwent a complete redesign andmodernization. The reactor has been in continuous operation since it resumednormal operations in 1993. For this reason it is considered to be arelatively new reactor with an operating life extending beyond 2020.
Covidien is a leading global healthcare products company that createsinnovative medical solutions for better patient outcomes and delivers valuethrough clinical leadership and excellence. Covidien manufactures,distributes and services a diverse range of industry-leading product lines inthree segments: Medical Devices, Pharmaceuticals and Medical Supplies. With2009 revenue of $10.7 billion, Covidien has 42,000 employees worldwide inmore than 60 countries, and its products are sold in over 140 countries.Please visit http://www.covidien.com to learn more about our business.
Any statements contained in this communication that do not describehistorical facts may constitute forward-looking statements as that term isdefined in the Private Securities Litigation Reform Act of 1995. Anyforward-looking statements contained herein are based on our management'scurrent beliefs and expectations, but are subject to a number of risks,uncertainties and changes in circumstances, which may cause actual results orCompany actions to differ materially from what is expressed or implied bythese statements. The factors that could cause actual future results todiffer materially from current expectations include, but are not limited to,the possibility that the Maria Research Reactor may not be able to supply Mo99 in a volume or form sufficient to meet our needs or at all, our ability toeffectively introduce and market new products or keep pace with advances intechnology, the reimbursement practices of a small number of large public andprivate insurers, cost-containment efforts of customers, purchasing groups,third-party payers and governmental organizations, intellectual propertyrights disputes, complex and costly regulation, including healthcare fraudand abuse regulations, manufacturing or supply chain problems or disruptions,rising commodity costs, recalls or safety alerts and negative publicityrelating to Covidien or its products, product liability losses and otherlitigation liability, including legacy Tyco-related litigation, divestituresof some of our businesses or product lines, our ability to execute strategicacquisitions of, investments in or alliances with other companies andbusinesses, competition, risks associated with doing business outside of theUnited States, foreign currency exchange rates or potential environmentalliabilities. These and other factors are identified and described in moredetail in our filings with the SEC. We disclaim any obligation to updatethese forward-looking statements other than as required by law.- 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.
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