08/19/2017

paying more for isotopes after supplier hikes prices New Research and Isotope Update From SNM

By Live Dr - Thu Jun 25, 11:56 am

Clinics are paying two to three times more for medical isotopes after a supplier abruptly hiked prices this month — shortly before the nuclear reactor that usually generates the bulk of the isotopes shut down temporarily.

The Chalk River, Ont., facility — known as the NRU, or National Research Universal, reactor — was shut down Friday after a leak of heavy water was discovered. The temporary closing of the aging reactor, which provides up to half the global supply of isotopes used in medical imaging, is expected to last more than a month.

Doctors fear the combination of a possible shortage and the increase in cost of isotopes, which are used in many diagnostic imaging procedures, might force some clinics to delay tests used to detect cancer and heart ailments, lay off staff or even close.

Lantheus Medical Imaging, a Massachusetts-based company that supplies clinics with the generators used in medical imaging, notified its customers last week of the price hike.

The Canadian Press obtained a letter Lantheus sent its customers on May 11 saying it had to raise prices after one of its suppliers started charging more for the isotope molybdenum 99, or Mo-99.

Supplier charging two to three times more

“Over the past several months, we have been engaged in negotiations of a new contract with one of our Mo-99 suppliers,” the letter says.

“Unfortunately, that supplier has demanded pricing two to three times higher than what we have been paying under our most recent agreement … Considering the magnitude of the molybdenum increase, we will have no choice but to implement a weekly surcharge.”

Lantheus’s supplier buys raw isotopes from Atomic Energy of Canada Ltd. (AECL), a Crown corporation. The supplier then sells those Mo-99 isotopes to Lantheus, which makes the lead-lined generators that hospitals use.

Physicians then run the generators through a process that produces another isotope, which is injected into the body to help radiologists in their diagnoses.

Lantheus did not name its supplier in the letter, but a government document obtained by The Canadian Press shows Ottawa-based MDS Nordion is the company’s sole supplier of Mo-99 isotopes.

In late January, a senior bureaucrat at Natural Resources Canada (NRCan) travelled to Paris to give a slideshow presentation to the Nuclear Energy Agency. A graphic in the presentation by Serge Dupont, associate deputy minister of NRCan, shows Lantheus receives its entire Mo-99 isotope supply from MDS Nordion.

A spokesman for AECL, Dale Coffin, also confirmed that MDS Nordion is Lantheus’s only supplier of isotopes.

AECL hasn’t raised price

Coffin also confirmed that AECL has not raised the price of the isotopes it supplies to MDS Nordion.

Lantheus and MDS Nordion wouldn’t comment Wednesday on their supply agreement.

An MDS Nordion spokeswoman said in an email the company “has taken no pricing actions related to the current NRU shutdown.”

AECL says it has enough medical isotopes for the coming week but won’t be able to meet demand by the weekend.

Dr. Christopher O’Brien, president of the Ontario Association of Nuclear Medicine, said an isotope price hike coupled with a supply shortage will pinch clinics.

“This is of extreme concern to us,” he said. “We are potentially looking at small hospital closures, job losses, technologists, nurses being fired … reduced patient access because the money’s not there now to buy the stuff.”

O’Brien said clinics began paying more for isotopes at the beginning of May.

He said he recently emailed Health Canada warning the added cost to clinics could range from $80,000 to $200,000 a year, depending on their size and how busy they are.

“This is equivalent to having no molybdenum, because the impact is the same where you’ll have to reduce access, not based on unavailability of isotopes but based on inability to pay for isotopes,” he said.

“So, the effect is still the same.”

Meanwhile, Lantheus announced a deal Wednesday with a subsidiary of the South African Nuclear Energy Corp. to supply it with isotopes.

A spokeswoman for Lantheus said in an email the company “will continue to receive supply from our primary supplier in addition to this new weekly Mo-99 supply.”

BusinessWire – Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, has finalized an arrangement with the Australian Nuclear Science and Technology Organisation (ANSTO) to receive molybdenum-99 (Mo-99) produced from low-enriched uranium (LEU) targets in ANSTO’s new OPAL reactor. This supply arrangement positions Lantheus to be the first company to supply technetium-99m (Tc-99m) derived from LEU to the U.S. market and demonstrates the Company’s commitment to ensuring reliable supply and global access to Tc-99m, the medical isotope used in approximately 80 percent of all nuclear medicine procedures.

Lantheus will soon receive a supply of Mo-99 at regular intervals from ANSTO, for use in its TechneLite(R) generator line that is currently distributed to the U.S. and Canadian markets. ANSTO has secured the necessary regulatory approval from the Therapeutic Goods Administration (TGA) in Australia to use the LEU Mo-99 in a Tc-99m generator. The LEU-derived Mo-99 from ANSTO has been tested and validated by Lantheus for use in its TechneLite(R) generator line to ensure the consistency and reliability that are the hallmarks of the TechneLite(R) brand. This arrangement supports Lantheus’ supply chain diversification strategy and marks another step to address the limited and fragile global Mo-99 supply chain, as evidenced by the current NRU reactor shutdown in Canada.

ANSTO is working closely with nuclear safety and health regulators, both domestically and overseas, to expedite all necessary approvals to allow long-term production and export of medical isotopes. Lantheus Medical Imaging, together with ANSTO, is working closely with the FDA and Health Canada to achieve the necessary LEU Mo-99 approvals for the U.S. and Canadian markets.

“This supply arrangement marks a significant step in the advancement of medical imaging – for the first time in industry history, we will be able to offer the nuclear medicine community in North America a LEU-derived Mo-99 through our TechneLite(R) generator line,” said Don Kiepert, president and CEO, Lantheus Medical Imaging, Inc. “We have been actively exploring new options for securing Mo-99 produced using LEU, and in ANSTO we have found an ideal partner with which to achieve that strategic goal. This arrangement will help ensure patients receive the benefits of diagnostic imaging with Tc-99m and at the same time support U.S. non-proliferation efforts to move from commercial use of HEU to LEU.”

Mr. Kiepert continues, “The efforts of ANSTO are more important now than ever before as our industry navigates through the challenges created by the outage of NRU reactor over the next several months. We are pleased to be working with the team from ANSTO to bring their LEU based Mo-99 into the global supply chain during this time of critical medical isotope need for patient care.”

“As Australia’s only nuclear research facility and leading authority on nuclear medicine, we play a significant role in providing Australians with access to timely medical imaging procedures that diagnose critical conditions and improve patient outcomes. We are happy to be working with Lantheus Medical Imaging because of its unparalleled reputation in the nuclear medicine industry for quality, reliability and superior technology,” said Ian Turner, ANSTO’s radiopharmaceutical general manager. “This relationship builds on our core complementary skills and helps provide a reliable Mo-99 supply using LEU in the U.S. and Canada.”

New Research and Isotope Update From SNM

by Kathy Mahdoubi, Editorial Coordinator

The Society of Nuclear Medicine press conference, held Monday June 15 in Toronto, was an eventful introduction to some of molecular imaging’s most exciting new research and technological developments, and a Q&A with members of the media on topics surrounding the shortage of Technetium-99, the essential medical radioisotope currently in short supply.

During the conference, former SNM President Dr. Robert Atcher indicated that the Society had formed an international alliance with governing bodies and corporations involved in the manufacturing and processing of medical isotopes that would meet quarterly to continue to find a long-term solution to the shortage. President Dr. Michael Graham hoped that the medical isotope issue would lead to greater knowledge and technological advancement within the field of molecular imaging.

“I’m particularly honored to take over as president of SNM in the midst of these challenging times. Indeed, with the isotope situation in a state of uncertainty, our profession faces a serious crisis — one of the most significant in our history,” said Dr. Graham. “It is my hope that we will all learn from these dangers and turn them into a world of opportunity and advancements that benefit the patient and community.”

The heart of the conference, however, was dedicated to revealing discoveries and new research submitted by members of the Society.

SNM Image of the Year

The SNM Image of the Year Award represents the year’s most striking visual case study in nuclear medicine. Since WWII, the field of nuclear medicine has been the source of innovative radionuclide therapies, from the use of radioactive iodide to treat thyroid disease, including cancer, to the advanced radioimmunotherapies that exist today.

The 2009 Image award was presented by Dr. Henry N. Wagner and revealed before and after PET scans of two patients with advanced, potentially fatal non-Hodgkin’s lymphoma (NHL). The patients were dramatically cured after intravenous radioimmunotherapy with either Yttrium-90 labeled Zevalin or Iodine-131 labeled Bexxar. Both drugs are FDA approved and combine the cancer-fighting radiation of medical radioisotopes with molecular compounds that are taken up by the tumor cells, making them powerful instruments in the treatment of cancer. Both patients showed no metabolically active NHL in as little as three months of therapy.

“The Image of the Year was chosen because it shows how molecular therapy can cure non-Hodgkin’s lymphoma and it provides objective evidence that the patient has been cured,” said Dr. Wagner.

The image was part of research conducted by Stanford University Medical Center that studied 71 patients with relapsed or refractory NHL. About 70 percent of patients treated with either Bexxar or Zevalin showed positive responses to treatment and about one third of patients showed no signs of the disease after treatment.

Another $1.5 billion study is promoting research for pre-targeted radioimmunotherapy, which has the potential to improve therapeutic response and reduce hematopoietic toxicity (bone marrow damage) compared to immunotherapy alone.

Skin cancer patch

A skin patch has been shown to successfully treat basal cell carcinoma, a common type of skin cancer that forms in the epidermis. The patch is custom-designed to fit over the skin lesion. The patch is sealed and non-toxic, administering radioactive phosphorous-32 that delivers beta radiation to the cancer cells. There is no sign of toxicity or external radiation hazard. The study conducted by the All India Institute of Medical Sciences, New Delhi, and the Bhabha Atomic Research Center, Mumbia, followed eight patients who elected to wear the patch instead of opting for surgery or radiotherapy. After sequential applications, each for three-hour lengths of time, biopsies of all patients’ skin cancer sites showed no sign of malignant cancer.

Potential cure for hard-to-treat prostate cancer

About 186,000 men are diagnosed with prostate cancer every year. A recent preclinical study revealed a new treatment for recurrent prostate cancer that targets and kills cancer cells with little damage to surrounding tissues. The alpha-particle emitting radiopeptide eradicated prostate cancer tumors in 70 percent of mice in a study conducted by the University of Basel, Switzerland. The treatment showed greater efficacy than similar treatments using beta-particle emitting radiopeptides. Researchers believe the therapy could provide effective treatment for other forms of cancer, as well, most notably breast cancer, said Dr. Peter S. Conti, former president of SNM and professor of radiology, clinical pharmacy, and biomedical engineering at the University of Southern California’s Keck Schools of Medicine, Pharmacy and Engineering.

“This is a rather dramatic presentation of a response in an animal, in this particular case bearing a tumor before therapy and after therapy complete resolution of the cancer following treatment with 213-Bismuth,” Dr. Conti said.

Motion-frozen hearts for better PET imaging

Cedars-Sinai Medical Center in Los Angeles has developed “Motion-Frozen” reconstruction technology, an image-processing technique that compensates for the motion of the beating heart. The technology reduces distortion and improves the clarity of PET cardiac imaging, especially in the case of myocardial perfusion studies. About 550,000 new cases of heart failure are diagnosed each year, said Conti. The technology could provide a more accurate means of detecting heart disease.

PET/MR prototype is making waves

On the most experimental front of positron imaging, the combination of positron emission tomography and magnetic resonance imaging (PET/MR) is the newest development in a line of imaging hybrids. The prototype technology could prove to be a superior imaging system for detecting breast cancer and has been shown in clinical studies to provide “excellent mapping of liver and kidneys” with the use of the radionuclide C-11 Methionine, “which shows potential for other agents,” said Dr. Conti.

“We envision this moving relatively quickly in the next couple of years into human use applications,” said Dr. Conti. “We’ve got a very exciting opportunity because we now have the ability to choose between PET/MR and PET/CT.”

Better detection of dementia may be possible with PET

A study by the University of Michigan, Ann Arbor, showed that PET scans could improve the accuracy of dementia diagnosis, said Conti. PET improved diagnostic accuracy in more than one out of four patients over other imaging systems. Each year, more than 5 million people are diagnosed with a form of dementia, including Alzheimer’s. PET imaging for dementia could lead to early detection and appropriate treatments.

Medical isotope crisis

Fact: 70 to 80 percent of all nuclear medicine procedures use Technetium-99, a radioisotope decayed from Molybdenum-99, the now relatively scarce isotope. Molybdenum is created in a nuclear fission reaction when a neutron is added to the stable isotope Moly-98. There are currently five reactors set up to produce this isotope, including Canada’s NRU reactor, also known as the Chalk River facility. This facility was shut down following a power outage May 14, 2009. Inspections led to the discovery of a water leak – -the third in two years for the 52-year-old reactor. The average age of all five reactors is 47 years.

“It’s clear that too many demands are being placed on too few facilities that are simply too old,” said Dr. Atcher. “Despite extensive efforts to maintain and modernize these facilities, they are simply too undependable to keep up with the growing demand of medical isotopes and can therefore no longer be depended upon as the sole sources of molybdenum-99.”

The Canadian Maple plant, two reactors which were built in part by MDS Nordion to produce the majority, if not all the U.S. demand for Molybdenum, have been sitting dormant and now it looks as though they may never come online.

“There are numerous issues with that facility,” said Dr. Atcher. “The reactor is not operating according to its specifications. The decision was not to operate it.”

In addition, Canadian prime minister Stephen Harper has announced that Canada will no longer produce medical isotopes as of 2016, said Atcher.

The U.S. government also wants a shift from highly enriched uranium targets to lowly enriched uranium targets that do not encourage weapons proliferation. The Maple facility was not set up for so-called LEU targets.

Coordinated shutdowns, diversification of sources, the restart of the Chalk River facility and Covidien’s future development of a LEU reactor with Babcock & Wilcox should alleviate some of the stress on the Molybdenum market, but a more sustainable solution has not yet been presented.

“We are confident that we can lift the world out of the crises to prevent future shortages,” said Dr. Graham.

Future developments

The president called on regulators and funding bodies to work in close collaboration with scientists and suppliers to push new agents through. SNM is spearheading a clinical trials network and will be promoting ARRA funding for comparative effectiveness studies in molecular imaging.

“We are moving into an era of molecular imaging and our physicians are going to be called molecular imaging physicians in the future,” said Graham. As the field becomes increasingly more advanced, the same level of advancement in physician training is required. SNM endeavors to be at forefront of that training in order to ensure that patients receive the best care possible.

Read More on DOTmed

Related DOTmed News reports about the 56th SNM annual meeting, the radiopharmaceutical shortage, and nuclear medicine topics:

Industry Sector Report: Nuclear Medicine, DOTmed Business News, June 2009, now online

MO-99 Suppliers Find New Sources
http://www.dotmed.com/news/story/9406/

SNM Outgoing President Robert Atcher Discusses Isotope Supply and Molecular Imaging
http://www.dotmed.com/news/story/9343/

Canadian Health Minister and SNM Leaders Meet in Toronto
http://www.dotmed.com/news/story/9346/

Medical Isotope Shortage Reaching Crisis Proportions
http://www.dotmed.com/news/story/9325/

SNM Past President Alexander J. (Sandy) McEwan Named Special Advisor to Canada’s Minister of Health
http://www.dotmed.com/news/story/9405/

Lantheus Medical Imaging Takes Steps on Mo-99 Shortage
http://www.dotmed.com/news/story/9206/

MDS Nordion Opens New Radiopharmaceutical Production Facility in Belgium
http://www.dotmed.com/news/story/9207/

An Interview With Henry Wagner, M.D.
http://www.dotmed.com/news/story/9057/

Serious Concerns as Isotope Shortage Looms
http://www.dotmed.com/news/story/6859/

Canada Stops Medical Isotope Reactor Project
http://www.dotmed.com/news/story/6026/

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