AMIC is committed to providing radioisotopes to the US health market.

While today’s news headlines are dominated by the rising price of oil and the collapsing housing market, another—possibly more serious—issue has received short shrift. Since November 2007, the supply of radioisotopes for diagnosis, treatment, and research for a wide variety of diseases, in particular cancer, has been, at best, unreliable.

The problem began in late 2007 when a Canadian supplier used by MDS Nordion was forced to temporarily shut down its radioisotope production facility. The plant, owned and operated by Atomic Energy of Canada Limited (AECL), is important because it provides a wide array of isotopes, including technetium Tc 99m, one of the most used in nuclear medicine, according to Robert W. Atcher, PhD, MBA, president of the Society for Nuclear Medicine. We’re doing fine 97% to 98% of the time,” he said. “Most cases are fine if we have to wait, but there are some cases that can’t wait, and you can’t [imagine] the impact on the patient and family in those 2% to 3% of cases. We need a reliable source of isotopes.”

About 90% of all the radioisotopes used in the United States are imported with 50% having come directly from the AECL plant and the other 50% being supplied by Covidien (formerly Mallinkrodt). The remaining 10% produced in the United States are done so in a fragmented, piecemeal manner with companies producing a single, hallmark isotope instead of a wide variety.

The Top 13

In the next 2 to 3 years, AMIC plans to produce and market what company officials call the “top 13” radioisotopes.

  1. Actinium 225
    Used for advanced research in therapy of leukemia and other cancers. It holds great promise for treating HIV/AIDS.
  2. Carbon 11
    Used in cancer diagnosis/staging, and as a radiotracer in PET scans to study normal/abnormal brain functions related to various drug addictions. It is also used to evaluate disease such as Alzheimer’s, epilepsy, Parkinson’s, and heart disease.
  3. Cobalt 57
    Used for gamma camera calibration. It is also used as a radiotracer in research and a source for x-ray fluorescence spectroscopy.
  4. Copper 64
    Used in PET scanning, planar imaging, SPECT imaging, dosimetry studies, and cerebral and myocardial blood flow. It is also used in stem cell research and cancer treatments.
  5. Fluorine 18
    This is the primary PET imaging isotope. It is used for cancer detection, heart imaging, and brain imaging.
  6. Germanium 68/Gallium 68
    It is used for study of thrombosis and atherosclerosis, PET imaging, detection of pancreatic cancer, and attenuation correction.
  7. Indium 111
    Used for infection imaging, cancer treatments, and tracer studies.
  8. Iodine 123
    Used in brain, thyroid, kidney, and myocardial imaging, cerebral blood flow (ideal for imaging), and neurological disease (Alzheimer’s).
  9. Iodine 124
    This is a radiotracer used in PET imaging and to create images of human thyroid. Other treatment uses include apoptosis, cancer biotherapy, glioma, heart disease, mediastinal micrometastases, and thyroid cancer.
  10. Iodine 131
    Used for diagnosis and treatment of thyroid disease, including cancer.
  11. Molybdenum (Mo) 99/Technetium Tc 99m
    Mo 99 is the “parent” of Tc 99m. It is the favored choice among medical professionals because its chemical properties allow it to be bonded to many different chemical materials, thus allowing use for a wide variety of diagnoses.
  12. Strontium 82/Rubidium 82
    Used as a myocardial imaging agent, early detection of coronary artery disease, PET imaging, blood flow tracers, etc.
  13. Thallium 201
    Used in clinical cardiology, heart imaging, myocardial perfusion studies, and cellular dosimetry.

The imported isotopes are used in 25 million procedures per year, about 1 million of which are for therapeutic procedures. Though the four-week shutdown of the Nordion facility caused some problems, Atcher said that, at worst, it delayed some imaging studies. It points to a problem that Advanced Medical Isotope Corp (AMIC) plans to remedy by bringing radioisotope production back to US soil and in the hands of a private company. “We have a moral imperative to produce isotopes on our soil for our people,” said Jim Katzaroff, founder, CEO, and chairman of AMIC.

This moral imperative was a long time coming and AMIC was created in anticipation of the suspension at the AECL facility. “Through intelligence gathering that we had done, we identified what was happening out there and got ready,” said Katzaroff. AMIC was founded in May 2006 and began production in July 2008.

Firing Up

AMIC officials say they plan to produce at least 13 different radioisotopes (see sidebar: The Top 13) at both the company’s Kennewick, Wash, headquarters and regional facilities sited across the country. The 13 isotopes are the ones the company has identified as “the most important commercially and for research,” said Robert E. Schenter, PhD, AMIC’s chief science officer. “They’re the future of AMIC.”

The company’s ambitious plan is tempered by the realities of the market. Each isotope will be made available as customers are secured. In fact, the first isotope that it is producing for sale is not Tc 99m, but fluorine 18, a short-lived isotope used for PET scans. “We’re doing one isotope at a time because of funding,” said Fu-Min Su, PhD, AMIC’s radiochemistry manager and radiosafety officer. “Building [accelerators] and manufacturing is not easy, and investing can be difficult. The perception is that these are radioactive devices with a lot of liability and little reward.”

The reality is that producing isotopes on US soil would save tens of millions of dollars for the health care market—which already spends about $120 billion per year on cancer, a number that is likely to skyrocket with the aging Baby Boomer population relying more and more on radio imaging and therapy to combat a variety of diseases, including cancer. In fact, two of the isotopes AMIC plans to produce—iodine 131 and Bexxar (iodine I 131 tositumomab)—are used to treat thyroid and other forms of cancer and non-Hodgkins lymphoma, respectively. By having regional centers, more researchers and physicians will also have access to extremely short-lived isotopes. Carbon 11 has a half-life of 20 minutes and fluorine 18 has one of 2 hours.

The company has state-of-the-art technology that it is bringing to the fore in producing its isotopes. Its primary equipment at the AMIC production center is a proton linear accelerator or PULSAR, which was manufactured by Hitachi subsidiary AccSys Technology Inc of Pleasanton, Calif. The compact proton accelerators are designed to replace large and demanding cyclotron systems for the production of positron-emitting isotopes. Using the device, Su and his team can produce fluorine 18, carbon 11, nitrogen 13, and oxygen 15 in large enough commercial quantities to use them in oncology, cardiology, neurology, and molecular imaging. In addition, the radiolabeled glucose analog, FDG, can be synthesized and distributed for use in PET.

The company is looking to the future, according to Su; the large, several-thousand-square-foot production facility has room to grow, so lack of space should not hinder the ability of AMIC to grow with the market. The company currently has 17 employees.

AMIC president Bill Stokes said that having control over production will allow the company to meet customer needs fairly rapidly, once demand grows. “We will be able to accommodate any request as long as the isotope has a reasonable half-life,” he said.

The company also is looking forward to doing custom work in addition to the tried and true. “The ability to do custom work is critical to our business plan,” said Katzaroff. “And another key is the kind of isotopes we are going to produce.”

The company is hinging its success not only on its state-of-the-art production facilities and its scientific and marketing know-how, but also on building a series of production and trading alliances.


AMIC has entered into agreements to produce isotopes at Idaho State University, the University of Missouri at Columbia, the State University of New York at Buffalo, and the University of Utah.

These regional university centers will allow AMIC to become a local supplier for the short-lived isotopes like fluorine 18. The relationships with these university research-oriented establishments will also help the company broaden its product base and market reach (see sidebar: Absorbable Brachytherapy).

Absorbable Brachytherapy

Though Advanced Medical Isotope Corp (AMIC) is focused on the production and distribution of medical isotopes, it is also looking to expand its horizons. To that end, it recently entered into an agreement to further develop a brachytherapy treatment with Battelle, which operates the Pacific Northwest National Laboratory (PNNL), and the Department of Pharmaceutics and Pharmaceutical Chemistry at the University of Utah.

The device will deliver a controlled dose of yttrium 90 microspheres embedded in resorbable seed-shape materials for tissue-directed, high-dose intratumoral therapy. Use of yttrium 90 will help to minimize the radiation dose to nearby normal tissues compared to x-rays from standard seeds. This technology is designed to improve the treatment of confined or nonresectable tumors. The coating on the seeds is similar in concept to the polymer used on over-the-counter pain relievers, according to company CEO and chairman Jim Katzaroff.

This will also result in a more cost-effective form of treatment than the standard metallic seeds, and could deliver a more “biologically effective” radiation dose.

AMIC likely will seek new medical device approval from the Food and Drug Administration in 2009.

—C.A. Wolski

The company is also working with United Pharmacy Partners Inc (UPPI), which helps to supply nuclear pharmacies. The relationship is a good one, said Su, and UPPI is eventually expected to become a distributor of AMIC products. During the recent Society of Nuclear Medicine conference in New Orleans, UPPI representatives sent many people—potential customers—to AMIC’s booth at the show.

Katzaroff has also brought AMIC to the attention of government heavyweights. He recently was fortunate to have dinner with Senator Tom Harkin of Iowa, a member of the Health, Education, Labor, and Pensions Committee, and discuss the importance of radioisotopes with him.

While AMIC has had some good early successes and has caused a stir in the supplier, government, and clinical marketplaces, its competitors have had a more complicated reaction.

Competitors’ Reaction

In light of the Society of Nuclear Medicine conference, Katzaroff said that the competition is “talking about us.”

But being the new kid on the block and the complications of starting an isotope business with its numerous hurdles—licenses, approvals, capital outlay—seem to be engendering more of a wait-and-see approach. “They’re not nervous—and they won’t be until we start taking away their business,” said Schenter.

However, Schenter added, those companies that do not produce fluorine 18 (and the other isotopes the company plans to market) have been very interested in partnering with AMIC.

The company has also been approached by customers in India and Iraq, among others, to supply medical isotopes.

Ironically, it is AMIC’s biggest potential competitor—the federal government—that could benefit most from the company succeeding.

Government Failure

At one time, the US government was supposed to be the source of medical isotopes, but over the course of the last two decades, it has either closed or failed to adequately fund its production facilities. “For the past 20 years, the government has been a dismal failure as a supplier. Oak Ridge makes nothing and only certain ones are made at Los Alamos,” said Schenter.

This is a big change from the 1980s when the Department of Energy—which oversees nuclear materials in the United States—was providing a steady supply. This included a reactor that produced 80 different isotopes, which the department eventually shut down.

Schenter said that AMIC’s success would be good for the government. “It would save it from embarrassment,” he said.

To underscore the important role that AMIC could play, the Society of Nuclear Medicine’s Atcher outlined a sort of medical doomsday scenario. If a reliable domestic supply of isotopes didn’t exist, because the United States closed its borders, then nuclear medicine would grind to a halt. Stokes gave the exact time frame—nuclear medicine departments would shut down in a week. “The nuclear science infrastructure has been allowed to atrophy,” Stokes said. “We are more and more dependent on critical assets [from other countries].”

Katzaroff admits the company still has more to do, but Schenter sees the light at the end of the tunnel. “We’ll be a major force in 3 years,” he said.

C.A. Wolski is a contributing writer for Axis Imaging News. For more information, contact .