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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
New Growth for Diagnostic RadiopharmaceuticalsOct. 22, 2006
There has been a strong focus on developing imaging platforms with broad applicability to various disease processes rather than narrowly targeted products. This is quite a departure from past experience with nuclear medicine, where research was based on products with very limited indications. Although it is true that FDA approval is genially metered out in small increments for specific indications, the underpinnings or principles involved with new products have been broadened so that they can be adapted to a wider market base. Broad imaging platforms have many benefits in that clinicians are willing to invest their time and effort to develop the skills to use the products effectively. As new indications are approved, they can readily adapt their skills to the new applications. Investors are also willing to take larger risks where the market opportunities are broad. Based on the number of new radiopharmaceutical products in the pipeline and the amount of venture capital being directed toward these developments, the future looks promising. Improvements in the FDA review process have also helped reduce the time for approval, allowing new products to be commercialized more rapidly. The number of partnerships and joint ventures has increased measurably, as nuclear medicine has moved closer to biotechnology in terms of mechanisms of targeting. As a result, it has become more important to utilize developments in other domains to build on nuclear medicine's existing strengths. In many cases, it has been possible to label selected molecules with appropriate radiotracers, benefiting from the new and innovative targeting mechanisms developed by others. Molecular imaging platforms are being developed based on apoptosis, angiogenesis and PLE (Phospho-Lipid Ether) tumor targeting that will employ both SPECT and PET imaging. This will include new oncology products for diagnosing and monitoring cellular response to therapy. These molecular imaging platforms will also have therapeutic applications, increasing their versatility and usefulness. Therapeutic radiopharmaceuticals will also employ molecular imaging to assess biodistribution and aid in developing patient specific dosimetry necessary for optimizing dosage and evaluating patient response to therapy. Market Overview
The U.S. market for diagnostic radiopharmaceuticals reached $1.69 billion in 2005 and is expected to rise to $3.52 billion by 2012. This forecast is based on the introduction of new products for cardiology and oncology and continued growth of PET imaging and sales of FDG. Sales of nuclear cardiology products will continue to drive the radiopharmaceutical market, with high utilization of nuclear perfusion studies coupled with advanced pharmacologic stress agents and introduction of new products for imaging myocardial infarction and congestive heart failure. Therefore, nuclear cardiology sales of $1.21 billion in 2005 will increase to $2.11 billion by 2012.In addition, new PET radiopharmaceuticals in the pipeline for specialized applications should add to these sales estimates. Market growth should also benefit from higher prices for many of the new products. More biopharmaceutical products for SPECT imaging will incorporate combined molecular imaging and therapy platforms with broad applicability to many different types of cancer, expanding the range of nuclear procedures. Availability of SPECT-CT will also add an important dimension to these new agents, aiding in image interpretation. This technical influx will help all segments of nuclear medicine, expanding the platform for molecular imaging. One effect is that clinicians will have more options as alternatives to higher risk and more costly invasive procedures. This will stimulate more research and investment, adding strength and stability to newer venture companies as well as those more established in the field. New Cardiology Products
A number of new nuclear cardiology products are in late stage development, which should help maintain momentum in this market. Two of these products have been approved in Japan and have been used effectively on a large number of patients. These products have been licensed to US firms and are in Phase 3 clinical trials, which should allow FDA approval by the end of 2007 or early 2008. Molecular Insight Pharmaceuticals is developing I-123 BMIPP (Zemiva) and GE Healthcare is developing I-123 MIBG (Androview).I-123 BMIPP is based on fatty acid metabolism and will be utilized in cases of acute myocardial infarction, where pharmacologic stress or exercise stress would be hazardous to the patient. The product is long lasting and allows imaging for several days after a suspected infarction. The clinician can then develop the most effective treatment protocol based on interpretation of these images. I-123-MIBG is a product that amplifies the androgenic receptors and neuronal pathways in the heart. Sometimes these receptors are upregulated or downregulated with negative effects on myocardial performance. Consequently, understanding the capabilities of these receptors provides the necessary diagnostic information for analyzing congestive heart failure. It also allows an image to be produced that supplies the pertinent information. The imbalance in the androgenic receptors indicates the patients at risk of congestive heart failure who would be candidates for pacemakers. This is particularly important in patients with potential heart failure that could be fatal. Another version of this product, I-131 MIBG is being developed by Molecular Insight Pharmaceuticals. However, this is in an earlier stage of development. This may provide an additional option for the physician that might be more appropriate in certain cases. Change in Focus of New Product Development
For several years there was an effort to create diagnostic-therapeutic pairs of nuclear products utilizing the same targeting principle. This was prompted by the approval of Zevalin and Bexxar for treating non-Hodgkin’s lymphoma. The objective was to employ nuclear imaging to assess biodistribution prior to therapy utilizing the imaging analog of the targeted antibody or peptide. This would increase confidence in the targeting capability of the therapeutic agent and its affinity for the receptors on the targeted cells. Immunomedics and others pursued these options for a number of years. Essentially, they tried to create a stronger link between targeted imaging and therapeutic products, based on the same antibody or peptide.Unfortunately, this approach was not economically viable because of the large investment required to develop new diagnostic products and the relatively limited market for any particular product. Whereas therapeutic products command prices in the range of $20,000-$30,000 per dose, specialized diagnostic products are traditionally priced under $1,000. In addition, the dominance of PET and other whole body modalities in oncologic imaging virtually neutralized opportunities for specialized SPECT agents in oncology. Therefore, oncology products have progressed from narrowly designed receptor-based agents for specific types of tumors to broader-based platforms for imaging a wider array of cancers. In many cases, this permits the clinician to carefully monitor specific cancers and also evaluate metastatic spread in the body. Integrin Product for Angiogenesis
Clinical trials have begun to measure the angiogenesis phenomenon that takes place in the remodeling of the heart following myocardial infarction. Immediately following infarct, there is no rebuilding of the heart, so there is a negative image of the zone at risk with this agent. However, as time progresses, one can see the uptake in the remodeling area. Comparatively, a thallium scan would remain negative with respect to the defect. Therefore, if there is an uptake in the remodeling area, one can assume the generation of new vasculature. The angiogenesis effect is also being pursued actively for monitoring breast cancer patients as well as other cancers. The peptide employed has an affinity for the ?v?3 integrin receptors on the surface of newly formed blood vessels that supply the tumor. Therefore, this agent can assess the effectiveness of chemotherapy and aid in monitoring patients receiving treatment. The breast cancer angiogenesis product has been adapted for both SPECT imaging and PET imaging. The integrin PET agent measures metabolic activity more accurately than FDG because of the ?v?3 receptors on the neovasculature of rapidly growing tumors. If one can detect these receptors in high concentration, it would indicate a fairly aggressive tumor. Phospholipid Ether Analogs (PLE) Platform
Several companies are developing novel agents that are capable of functioning as both tumor selective imaging and therapeutic agents. One company, Cellectar, is developing its Phospholipid Ether Analogs (PLE) platform as functional, tumor-selective, SPECT and PET molecular imaging agents. In addition to these diagnostic-imaging modalities, the Company intends to aggressively develop its PLE tumor delivery platform to serve as a targeting system capable of treating a wide variety of cancers.Cellectar’s lead product, NM404, has been successfully labeled with the PET imaging isotope iodine-124 and imaging studies have shown that NM404 can provide good tumor imaging. Comparative studies using a large array of different PLE analogues are currently underway to specify the most optimal development candidate for PET imaging. Management believes that a faster accumulation kinetic (than available from NM404) may prove advantageous for diagnostic imaging. However this has to be proven in ongoing experiments. Iodine-124 is a relatively new isotope with an unusually long physical half-life of 4.2 days. This enables much easier logistical handling of the tracer than FDG. Cellectar believes that I-124-NM404 has certain advantages over FDG as follows:
ApoSense™ for Imaging Apoptosis (NST Ltd)
NST (Neuro Survival Technologies), an Israeli firm, has developed a set of proprietary compounds with demonstrated ability to identify, bind and accumulate within apoptotic (dying) cells in-vivo. This technology addresses a large clinical need across a range of molecular imaging and therapeutic applications. Its product platform ApoSense™ is a small molecule "Interfacial Nanoswitch™" designed to target cells undergoing apoptosis.The ApoSense™ technology is based on the apoptotic process, coupled with the implementation of molecular nanotechnology concepts, as follows:
Imaging infection and inflammation
For many years, there was extensive investment in new products to image infection and inflammation in vivo. This was an attempt to improve on the in vitro procedures employing indium oxine and Ceretec to label white blood cells. Several companies expended considerable effort on developing monoclonal antibodies and peptides for this purpose. Diseases such as fever of unknown origin and inflammatory bowel disease were typical of cases difficult to diagnose, even by invasive means. Infectious diseases are also associated with inflammation, which can have numerous causes. Interest also increased in diseases of the immune system, with a tendency to for infection and inflammation. Some chemotherapy regimes, for example, result in reduced immunological resistance to infection, which puts patients at risk.Nuclear medicine offers various methodologies for tracking infection and inflammation, but each is a compromise. Nuclear physicians have utilized gallium 67 citrate for some time; however, it is not very specific, and its imaging qualities are not optimal. In vitro labeling of white blood cells is another technique in which a sample of the patient's blood is separated, and white blood cells labeled with a radiotracer in vitro, and then reinjected into the patient. The path of the labeled white blood cells is tracked by a gamma camera to observe sites that have an affinity for white blood cells. This is a tedious process, which requires several repeat patient visits. It also involves risk to personnel handling potentially infected blood. Therefore, the goal has been to develop an in vivo agent capable of identifying sites of infection directly. This would not only accelerate the process of diagnosis and treatment, but would be safer for both patients and medical personnel. Draximage has a formulation known as “Infecton” which consists of ciproflaxacin labeled with technetium. Ciproflaxacin is an antibiotic that Draximage licensed from Bayer for this application. The product is in Phase 2, but the company expects to complete the necessary clinical trials by the end of 2007, which may allow approval in 2008. One advantage of the Draximage product is that it targets infection, rather than inflammation. Management feels that this is an advantage. Other products have targeted white cells. Therefore, they cannot distinguish infection from inflammation. Since patient management in the case of infection would be different than inflammation, use of the Draximage product may offer advantages. Future Prospects
Based on the number of new radiopharmaceutical products in the pipeline and the amount of venture capital being directed toward these developments, the future looks promising. Improvements in the FDA review process have also helped reduce the time for approval, allowing new products to be commercialized more rapidly.The number of partnerships and joint ventures has increased measurably, as nuclear medicine has moved closer to biotechnology in terms of mechanisms of targeting. As a result, it has become more important to utilize developments in other domains to build on nuclear medicine's existing platform. In many cases, it has been possible to label selected molecules with appropriate radiotracers, benefiting from the new and innovative targeting mechanisms developed by others. 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 based on obtaining FDA approval. 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
Oct. 22, 2006 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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