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Market Research in the Healthcare Field with Expertise in Medical Imaging and Radioisotopes
Bio-Tech Systems, Inc. - 4167 West Pinecrest Circle - Las Vegas, Nevada 89121 phone: (702) 456-7608 - fax: (702) 456-2189
Long-Term Opportunities in SPECT Despite Technetium ShortageMay 12, 2010
The fact that both reactors were down simultaneously was unusual since there was previously an attempt to maintain some overlap so at least one of the reactors could be kept going until the other could be brought back on line. However, the Chalk River reactor developed a major water leak that needed repair and this could not be delayed. Other reactor sources have been used to fill the gap recently including the Safari reactor in South Africa, the BR-2 reactor in Belgium, Osairis in France and ANSTO in Australia. In addition, Covidien recently signed an agreement with the Institute of Atomic Energy in Poland to augment its supply of Mo-99. Nordion has also been able to obtain some Mo 99 from a Russian reactor. Although these alternate sources have helped fill the gap, they have been unable to maintain sufficient output to satisfy the ongoing demand. There are other technologies being considered for producing Mo 99 that may materialize if the price of Mo-99 continues to increase. For many years, the price of technetium and Mo-99 were artificially low because the reactor operation was subsidized by the Canadian Government. The situation with the Petten reactor in Holland was similar. In both cases, there was insufficient investment in capital improvement or replacement of the ageing components, which led to operational failures and interruptions in supply. With reduced availability of Mo-99, the price has increased to about twice the level that it was previously. The available isotope must now be obtained from remote sources and shipped long distances, decaying during shipment. Since the market has accepted these higher costs, it has created a new price platform, which should allow new technologies to be implemented. High Energy Uranium (HEU) vs. Low Energy Uranium (LEU)
Most nuclear reactors that produce Mo-99 are dependent on high energy uranium targets, which are gradually being replaced by low energy uranium that meets national security requirements. Therefore, older reactors are being phased out gradually and new reactors built with LEU technology.
In North America, the U.S. Atomic Energy Commission strictly controls the supply of high energy uranium necessary for nuclear reactor targets and supplies these targets only to approved users. These are generally Government facilities or agencies that are able to obtain proper licensing to utilize these materials safely and maintain control over the nuclear waste. Effect of the Technetium Shortage on the SPECT Market
The interruptions in supply from AECL and Petten have put pressure on the nuclear imaging community to limit SPECT procedures in order to conserve the available technetium. Although efforts to develop alternate supplies around the globe have relieved the pressure, they have been insufficient to satisfy the demand.
Since current security requirements dictate that radioisotope production must be entirely converted to low energy uranium targets by 2017, it has required that current reactors using high energy targets be phased out and that one or more new reactors be built in North America based on LEU targets. With these constraints, a significant infusion of capital is required to offset the cost of building these new reactors. Long-term Prospects for Relieving the Technetium Shortage
AECL has done an exemplary job of producing the necessary quantities of Mo-99 to satisfy the requirements for technetium in North America. The U.S. Atomic Energy Agency supplies the high energy uranium targets for the NRU reactor. However, Congress has deemed that dependence on HEU cannot go on indefinitely. The U.S. Atomic Energy Agency has agreed to continue supplying HEU targets to AECL until 2017. However, plans must be implemented to make the transition to LEU or other technologies that do not require high energy uranium. This means that any capital expenditures to maintain facilities based on HEU will be limited. Therefore, repairs to the NRU reactor at Chalk Hill will provide only a patchwork solution.
Another reality is that nuclear cardiology studies based on technetium grew to more than 7 million in 2009. This is comprised to a large extent on cardiology private office procedures and the cardiologist’s ability to effectively maintain surveillance over a large group of patients with vascular stent implants. Although there has been some effort by insurers and Medicare to limit these procedures, they are quick, safe and effective and provide essential information at moderate cost. As the debate over the technetium shortage has continued, more effort has been devoted to developing alternate sources while the existing reactors are being repaired. As these secondary sources ramp up, they will be able to fill the gap more effectively in the future. Although there is still the deadline for discontinuing HEU produced Mo-99 in North America by 2017, other technologies will be implemented by that time that will overcome this limitation. In addition, international reactor sources will expand capacity to fill the gap more effectively. Improved Efficiency of New SPECT Cameras
Developments in SPECT cameras based on solid state detectors have accelerated in the past few years as the technology has improved and the price reduced. These cameras are more efficient than conventional SPECT cameras and produce superior images with reduced imaging time (from 15-20 minutes with conventional SPECT to 2-4 minutes for a comparable cardiology study). The technetium dose is also lower than required with traditional SPECT cameras. This should extend the available technetium supplies and allow more patients to be imaged.
Another aspect that will conserve technetium is the “stress-only” study. Leading nuclear physicians have utilized this protocol and have found it effective. It compresses imaging time and allows most nuclear studies to be performed in a single imaging session. In cases, where the stress study is abnormal, then the patient returns the following day for a resting study. However, this proportion is limited and the net result is that the number of doses utilized is reduced, extending the available technetium supplies. New Radiopharmaceuticals will Extend the Range of Nuclear Procedures
Recently, there has been significant investment in new proprietary radiopharmaceuticals for SPECT. An important area is in neurology to diagnose Parkinson's disease, distinguishing it from basic tremor. One of these new agents, DaTSCAN has been used successfully in Europe for over 10 years, but was not introduced in the U.S. because of the FDA's requirement for full scale clinical trials. As the clinical data from Europe accumulated, attesting to the product's safety and effectiveness, the FDA agreed to allow its introduction in the U.S. without a new and duplicative clinical trial. Therefore, GE will be able to introduce DaTSCAN in the U.S. by late 2010 or early 2011. Since the product will be priced in the range of $1,000 per dose, it should provide attractive revenues for GE while building a new platform in SPECT neurological imaging.
A similar product, Altropane should also be introduced in the near future. This product has been under development for some time and completed Phase 3 trials, but was sidelined by its developer, Boston Life Sciences because of financial limitations. Recently the product was sold to Alseras Pharmaceuticals, a company well positioned to complete development and introduce the product in the 2011 period. Because of the high incidence of neurological diseases such as Parkinson’s, this should open significant new opportunities in SPECT and molecular imaging. New Cardiology Products
In the cardiology field, perfusion studies with Cardiolite and Myoview will continue notwithstanding the higher price of technetium. However, opportunities are emerging for new cardiology products for imaging myocardial infarction and congestive heart failure. A new agent will soon be introduced by Molecular Insight Pharmaceuticals, Zemeva, which images myocardial perfusion and myocardial infarcts in patients who are brought to the emergency room and cannot tolerate either exercise or pharmacologic stress. The agent utilizes I 123 for imaging and is based on fatty acid metabolism, which replaces glucose metabolism during a heart attack. This I-123 agent has been used in Japan for many years and has provided a useful alternative to conventional SPECT perfusion imaging in many cases.
Other SPECT cardiology agents are also in late stage development for neuronal imaging to detect congestive heart failure. Disturbances in the neural pathways of the heart can be controlled with pacemakers and these new agents will indicate which patients are suitable candidates, improving the outcome for many who suffer with these cardiac abnormalities. GE has licensed one of these products (Androview) and has recently obtained FDA approval for its use in the U.S. These new cardiology agents will create a new platform that is not dependent on technetium. These agents can be used effectively in an outpatient setting and should create a new market opportunity that will benefit SPECT. New SPECT Agent for Imaging Prostate Cancer
Another new SPECT agent in the development pipeline is Trofex for imaging prostate cancer. This agent is being developed by Molecular Insight Pharmaceuticals and is based on and affinity to PSMA (Prostate Specific Membrane Antigen). Trofex allows imaging in 2 hours after injection and can image localized as well as metastatic prostate cancers. Previous attempts at imaging prostate cancer employed PSMA with an affinity for only surface antigen, whereas this agent has an affinity for all PSMA both inside the cancer cell as well as the cell surface. Therefore, it has many more sites for interaction, improving the statistics as well as image quality, while reducing the time required for imaging. This agent also utilizes I-123 for imaging, which provides superior image quality compared with other products of this type.
Future prospects
Based on the number of new SPECT radiopharmaceuticals in the pipeline and the amount of venture capital being directed toward these developments, the future looks promising. The FDA review process has also improved, allowing more rapid commercialization of these new products.
The number of partnerships and joint ventures has also increased measurably as nuclear medicine has moved closer to molecular imaging. In the process, nuclear medicine has utilized developments in other scientific to enhance its capabilities. Typically, it has been possible to label selected molecules with appropriate radiotracers, while benefiting from innovative targeting mechanisms. Both researchers and their corporate sponsors have developed a more realistic approach to pursuing product opportunities that have broad diagnostic and therapeutic potential rather than focusing on narrowly defined goals. The present philosophy recognizes the importance of creating products with broad market appeal that are both technically sound and economically viable to generate the revenues necessary to meet sensible investment criteria. by Marvin Burns
May 12, 2010 BIO-TECH SYSTEMS, INC., founded in 1980, provides clients with market research services in the healthcare field. This focuses on strategic planning, market research and development of new business opportunities. Bio Tech specializes in product and market evaluation where technical insight is important as well as the ability to communicate with many levels of management and end-users. One objective is to assess technological risk and target new products and services effectively in order to generate the best market response. Bio-Tech's expertise is in medical imaging and radioisotope products covering a broad range of diagnostic and therapeutic applications. For further details and information, please visit us at: Related Reading:
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