Thank you, Philippe.
My name is Steve Littlejohn. I'm with Covidien, a global health-care products company. I'm a vice-president at Covidien's pharmaceuticals segment, which is based in St. Louis, Missouri. I also co-chair our global task force that is helping to manage the challenging medical isotope crisis worldwide.
More than 35 million nuclear medicine procedures are performed worldwide each year. Approximately two million of these are performed in Canada using single photon emission computed tomography technology. While many people are unfamiliar with medical isotopes, they or a family member have probably benefited from this technology.
The technetium-99m that comes from molybdenum-99 is a vital medical isotope. It is used in over 80% of all nuclear medicine SPECT diagnostic and functional studies of organs and anatomical systems. The information from these studies is used by many medical specialists, including, among others, radiologists, nephrologists, oncologists, and cardiologists, to better diagnose and treat patients.
Throughout the molybdenum-99 shortage that began with the unexpected and now lengthy shutdown of the NRU reactor in Chalk River, Ontario, now combined with the planned shutdown of the High Flux Reactor in the Netherlands, we have had two primary goals.
Our top priority is maximizing patient access, as fairly as possible on a global level, to critical diagnostic procedures that depend on technetium-99m.
Second, transparent and frequent communications are crucial in our collaboration with the nuclear medicine community to help them plan as efficiently as possible to provide maximum access for those patients most critically in need of this vital isotope. We have also established a special web page to provide easier access to current information on the situation, which can be reached at www.covidien.com/mo99supply.
We believe that we have been successful in meeting both objectives, but a continued strong effort is still necessary over the next few months.
Covidien firmly believes in the value of a diverse supply of molybdenum-99. Long-standing supply arrangements with each of the major medical isotope reactors continue to be highly beneficial, as they have been throughout the shortage. The global molybdenum-99 supply chain is heavily interdependent and can be very fragile. There are many steps between the reactor and the patient. Any one of them may prove hazardous if all does not go as planned.
I'll depart from my remarks briefly right now to explicate that. Let's say that we start with a reactor. We'll talk about the Maria reactor in Poland. They'll do the irradiation cycle. That might take six or seven days. This reactor is about 30 kilometres east of Warsaw. When the irradiation is complete, the targets are put in special containers--a target is about the size of a ruler--and for about 22 hours they're trucked across Poland and Germany to our facility in Petten in the Netherlands. The processing period may take about 16 hours. Then the product is moved to a technetium generator facility in Petten or Europe or Africa. Also, molybdenum is shipped by air to our facility in Maryland Heights. It takes about 12 hours to get it across and into St. Louis. There's a six- or seven-hour production cycle, and then it's in the air again to patients.
If you calculate all of that, from the point at which it leaves Warsaw, Poland, to the time it reaches a patient in Canada, it is a matter of hours. You can add it up, but it's a very short time. It's very complex. Everything has to work right at each stage along the way. And as you know, and as you've heard many times, it can't be stored. It's all real time, and it's all a batch process.
Obviously, having two primary reactors down simultaneously is an extreme example of a break in the supply chain. In preparation for this possibility, Covidien took additional precautionary actions.
Since last May, Covidien has taken a host of measures to lead the industry in addressing the supply issues affecting the availability of medical isotopes. Some were designed for immediate impact. As I just mentioned, Covidien and the Institute of Atomic Energy in Poland, or IAE POLATOM, announced an agreement last month that will provide an additional resource for this critical medical isotope. The agreement adds IAE POLATOM's Maria research reactor to the global supply chain for molybdenum-99. More than a million additional patients are expected to benefit from this additional supply in just the first six months.
If you do the math, if you have roughly 30 million procedures in the world that use technetium and you multiply the one million to two million for annual.... At two million, you're getting close to 10%. That is not a lot in the grand context, but when you look at the millions of patients being helped that otherwise wouldn't be helped, and having a supply when there wouldn't otherwise be a supply, it makes a difference. I do want to note too that it brings the first new reactor into the worldwide supply chain in more than a decade to help meet the demands of medical isotopes in this time of critical shortage.
What I'm about to say is really important, and I want to really emphasize it. We work closely with Health Canada and the U.S. Food and Drug Administration, or FDA. Those two agencies worked together and collaborated in an extraordinary, admirable kind of way to ensure that approval came. But I want to make very clear that this was not a shortcut approval; this is what I call expeditious rigour--with the emphasis on the rigour.
We had people on both sides of the border in the regulatory agencies willing to work on weekends, willing to take pieces of material and process them. It was an extraordinary effort by the regulatory community all the way around to do two very important things: get molybdenum into the supply chain and into technetium generators for patients, but at the same time ensure safety. You've got to have both at the same time when you're working in this. So that was really extraordinary, and we're very grateful for that.
However, as I mentioned before, adding Maria will not completely replace the molybdenum 99 supply lost to the NRU or HFR shutdowns. As I said, it can only address about 10% of world demand. So our efforts towards maximizing the molybdenum supply arrangements with all viable sources continue.
We actively supported additional production cycles and an increase in the number of targets at Belgium’s BR2 reactor during the shutdown of HFR, and we continue to increase the production of the potential alternative: clinically appropriate medical isotopes such as thallium TI 201.
The combined use of molybdenum 99 from the remaining online reactors--Maria, BR2, OSIRIS in France, and Safari in South Africa--improves the outlook for the coming months. But we estimate intermittent ability to fully meet existing customer orders, with some periods of more serious shortages for technetium generators. This variability will be due to already scheduled brief maintenance shutdowns of the remaining molybdenum supply, including Maria.
Just to give you a better sense of that, referring to our calendars that we issue periodically.... We have one that will be issued as soon as we can get it translated into French into the Canadian market, rightfully. But just to highlight that, May is going to be a particularly difficult month. It could be difficult across the world. But at the same time, there are a number of dates in May that will be better, or at least not as bad, primarily because of the Maria reactor. The bright spots are May 9, 10, 20, 21, 28, and 29.
So we would hope with our communications that we can help physicians and other clinicians schedule appropriately to avoid the bad shortages and maybe be able to do it when there's a little bit extra available.
But we're not looking at just the short term, we're also looking at the long term. In January of 2009 Covidien formed a partnership with Babcock & Wilcox Technical Services Group, or B&W. We're collaborating to develop solution-based reactor technology for medical isotope production. This will combine our expertise in radiopharmaceutical production and processing, and global regulatory approvals, with B&W’s patented liquid phase nuclear technology, and will utilize low-enriched uranium or LEU. The current target for completion of that would be the middle to latter part of 2014.
We've also expressed support for the Dutch government’s efforts to develop the new Pallas reactor in the Netherlands. In addition, the Missouri University Research Reactor, or MURR, is also prominent in efforts to become a U.S.-based source of molybdenum 99 using LEU. Covidien is evaluating MURR as an optional supplier.
We also support the American Medical Isotopes Production Act in the U.S. Congress. The act promotes U.S. production of molybdenum 99 for medical isotopes manufacturing while also phasing out the export of highly enriched uranium for medical isotope production.
