Fidest – Agenzia giornalistica/press agency

Quotidiano di informazione – Anno 26 n° 320

Posts Tagged ‘nordion’

Global Nuclear Medicine

Posted by fidest on Tuesday, 2 April 2013

Dallas, PRNewswire The radioisotopes market is categorized into diagnostic and therapeutic applications. The diagnostic market consists of PET and SPECT technologies, while the therapy market comprises of beta emitters and brachytherapy seeds. The SPECT market accounted for a major share of the diagnostic segment in 2012. Significant radioisotopes in the SPECT diagnostic market are Tc-99m, Tl- 201, Ga-67, and I-123, while PET market is dominated by F-18, and Rb-82. The therapy market is led by I-131, Sm-153, Re-186, Y-90, and Lu-177. Alpha emitters are being developed and considered for cancer treatment, however not available commercially. It is estimated that Tc-99m diagnostic procedures are expected to increase by more than 15% in mature markets of North America, Europe, Japan, the Republic of Korea, and Oceania between 2010 and 2030, however shortage of Mo-99/Tc-99m has been a threat to this industry. The scheduled shutdown of the NRU reactor in 2016 and OSIRIS in France in 2018 is a major risk for manufacturers in the near future. Companies have increased the production of thallium to meet the shortage, as it is the most commonly used substitute for technetium-99 in cardiac-stress tests, conducted to evaluate the functioning of coronary arteries. Radiopharmaceuticals in neurological applications such as Alzheimer’s disease, Parkinsons disease, and dementia are also being preferred by practitioners besides conventional treatment. Further, upcoming radioisotopes such as Ra-223 (Alpharadin) and Ga-68 possess huge potential for clinical applications. Increasing use of SPECT and PET scans, technical advancements in equipment and other factors such as rising awareness of radiopharmaceuticals among physicians, alpha radioimmunotherapy based targeted cancer treatment, and ready availability of nuclear medicine market from cyclotrons have driven the market. High cost of devices using radioisotopes, short half-life, lack of good manufacturing practices, and stringent regulatory approvals are major hurdles to growth of the market. North America is the dominant market for diagnostic radioisotopes with close to half of the market share. The U.S. is the largest consumer market for radiopharmaceuticals, while Canada is one of the largest producers of Tc-99m. Processors such as Nordion, Inc., Covidien Plc., and NTP Radioisotopes Pty Ltd. run reactors that are involved in the irradiation of U-235 to make crude isotopes. They follow various strategies to achieve sustainable growth, one of which is shifting to Low Enriched Uranium (LEU) from High Enriched Uranium (HEU). These key players were mainly involved in strategic agreements and contracts with other institutes and players, while generator manufacturers followed several strategies to maintain a sustainable supply chain. The stable isotopes market was less than $150 million in 2012 and poised to grow at more than 10% CAGR in the next 5 years. Carbon-13 commanded the largest share of the global stable isotope market in 2012; however deuterium and oxygen show tremendous potential to grow in the near future. The market was dominated by two players, Cambridge Isotope Laboratories (CIL) (U.S.) and Isotec (Sigma Aldrich) (U.S.) in 2012 jointly contributing more than 90% to the global revenue.
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Nordion Announces Europe-Focused Phase III Clinical Trial for TheraSphere® Liver Cancer Treatment

Posted by fidest on Thursday, 26 April 2012

Ottawa, Ontario, (PRNewswire) Study to evaluate and compare safety and efficacy of TheraSphere® vs. sorafenib in hepatocellular carcinoma patients with portal vein thrombosis
Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services for the prevention, diagnosis and treatment of disease, today announced an additional randomized, multi-centre Phase III clinical trial for TheraSphere®, Nordion’s yttrium-90 (Y-90) glass microsphere treatment for liver cancer.The YES-P trial will be focused primarily in Europe, with additional locations to be identified globally, and is targeting enrolment of about 350 patients at approximately 24 sites. The trial will further evaluate the safety and efficacy of TheraSphere® in the treatment of patients with portal vein thrombosis (PVT) associated with unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer.PVT, a complication in which a clot forms in one of the blood vessels feeding the liver, occurs in approximately 30 to 40% of HCC cases. The presence of PVT is a contraindication for most embolic therapies, but TheraSphere® represents a safe alternative.”Nordion is excited to directly address the important question of whether TheraSphere® can extend the lives of this sub-group of HCC patients, where typical life expectancy remains unacceptably low,” said Mason Ross, MD, Nordion’s Vice President of Medical Affairs. “YES-P is our first major clinical trial that will be primarily conducted in Europe, thus supporting our commitment to increase our global clinical research footprint while building on the knowledge of how TheraSphere® may improve survival compared to sorafenib.”The trial will follow a two-armed design. In one arm, patients will undergo Y-90 radioembolization treatment with TheraSphere®, while patients in the other arm will receive sorafenib.In the last 13 months, Nordion has also announced two additional Phase III clinical trials for TheraSphere®: STOP-HCC, involving patients with HCC, and EPOCH, involving patients with colorectal cancer whose disease has metastasized to the liver. TheraSphere® is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive Y-90. The product is injected by physicians into the artery of the patient’s liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow. TheraSphere® is used in the European Union and in Canada for the treatment of hepatic neoplasia in patients who have appropriately positioned arterial catheters.
Nordion Inc. (TSX: NDN) (NYSE: NDZ) is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes, targeted therapies and sterilization technologies that benefit the lives of millions of people in more than 60 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has more than 500 highly skilled employees in three locations. Find out more at http://www.nordion.com and follow us at http://twitter.com/NordionInc.

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Nordion Launches Custom Doses for TheraSphere® Liver Cancer Therapy in Europe and Canada

Posted by fidest on Monday, 26 March 2012

Ottawa, Canada (PRNewswire) Nordion Inc. (TSX: NDN) (NYSE: NDZ), a leading provider of products and services for the prevention, diagnosis and treatment of disease, today launched a new custom dose feature in Europe and Canada for TheraSphere®, Nordion’s Y-90 microsphere treatment for liver cancer. Nordion has also filed a request with the Food and Drug Administration for approval of the custom dose feature in the United States.In addition to standard dose vial configurations, Nordion now offers an expanded range of TheraSphere treatment options with custom doses available in wider variety of increments. The custom doses are designed to provide greater treatment flexibility for physicians, save administration time and reduce product waste, while limiting unnecessary radiation exposure to patients and healthcare professionals.Nordion has also enhanced its Treatment Window Illustrator tool to demonstrate how custom doses can be selected and compared to standard dose vial configurations.Nordion is attending the Society of Interventional Radiology (SIR) Annual Scientific Meeting 2012, March 24-29, in San Francisco. Nordion representatives will be at Booth #1234 to talk about TheraSphere to physicians attending the conference. Nordion will host two “Eat and Be Educated” learning sessions at its booth:
TheraSphere is a liver cancer therapy that consists of millions of small glass beads (20 to 30 micrometers in diameter) containing radioactive yttrium-90 (Y-90). The product is injected by physicians into the artery of the patient’s liver through a catheter, which allows the treatment to be delivered directly to the tumour via blood flow. In the US, TheraSphere is used to treat patients with unresectable hepatocellular carcinoma (HCC), the most common form of primary liver cancer, and can be used as a bridge to surgery or transplantation in these patients. It is also indicated for the treatment of HCC patients with portal vein thrombosis (PVT). TheraSphere is approved by the U.S Food and Drug Administration (FDA) under a Humanitarian Device Exemption (HDE). HDE approvals are based on demonstrated safety and probable clinical benefit. However, effectiveness of the indication for use has not been established.
Nordion Inc. (TSX: NDN) (NYSE: NDZ) is a global health science company that provides market-leading products used for the prevention, diagnosis and treatment of disease. We are a leading provider of medical isotopes, targeted therapies and sterilization technologies that benefit the lives of millions of people in more than 60 countries around the world. Our products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion has more than 500 highly skilled employees in three locations. Find out more at http://www.nordion.com and follow us at http://twitter.com/NordionInc.

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