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COLUMBIA, MO, March 29, 2017
The University of Missouri Research Reactor (MURR®) and its partners Nordion, a business of Sterigenics International, and General Atomics (GA), announce that MURR’s License Amendment Request (LAR) has been submitted to the U.S. Nuclear Regulatory Commission (NRC). This marks a critical step towards implementing domestic U.S. production of molybdenum-99 (Mo-99). Once operational, production from this facility will be capable of supporting nearly half of U.S. demand for Mo-99, which currently must be imported from outside North America.
A medical isotope is a safe radioactive substance used by health professionals to diagnose and treat patients who suffer from a variety of conditions, including cardiovascular disease and cancer. Almost 50 million such procedures are performed every year. The most important isotope, technetium-99m (Tc-99m), is produced from Mo-99 and is used in more than 80 percent of all nuclear medicine procedures.
“This LAR submission shows the Nuclear Regulatory Commission that we will have all of the technology, expertise and safety measures needed to begin producing Mo-99 in place and ready to go once approval has been received,” said Ralph Butler, Executive Director of MURR®. “As a public research institution, we are proud to play a partnership role with GA and Nordion in helping America secure a new, domestic source of Mo-99.”
Once approved by the NRC, MURR® will begin producing Mo-99 using selective gaseous extraction (SGE), a unique proprietary technology developed by General Atomics to extract the isotope from Low Enriched Uranium (LEU) targets. This patented approach will produce Mo-99 of the highest specific activity, while avoiding the production of liquid uranium waste, a significant problem with existing technologies that require Highly Enriched Uranium (HEU). Extracted Mo-99 will be transported to Nordion’s facility in Ottawa, Ontario, for final purification and distribution to radiopharmaceutical manufacturers, after which it will be distributed to hospitals and medical facilities around the world.
“We will start receiving Mo-99 from MURR in mid-to late-2018,” said Phil Larabie, Vice President, Medical Isotopes for Nordion. “Filing this license amendment is a key step in our efforts to stabilize and support the nuclear medicine community in North America and beyond for decades to come.”
In addition, Nordion is maintaining its conventional Mo-99 processing capacity through March 31, 2018, in the event of a significant global shortage of Mo-99.
The MURR® project is being conducted with the active support of the U.S. Department of Energy’s National Nuclear Security Administration (NNSA), which was mandated to help secure a new, reliable domestic supply of Mo-99 by the American Medical Isotopes Production Act of 2012 (AMIPA). The approval of MURR®’s LAR represents a major step toward achieving this goal.
About University of Missouri Research Reactor (MURR®)
The University of Missouri Research Reactor Center (MURR®) has a long history of safe reliability. With its 10-MW reactor and a 6½-days-per-week, 52-week-per-year operating schedule, MURR supports research and education while also providing short-lived isotopes for medical applications. MURR provides a range of radioisotopes that help medical professionals diagnose and treat many diseases, including cardiovascular disease and cancer. The nation‘s largest university research reactor also supports undergraduate and graduate education programs that train the next generation of nuclear engineers and chemists. For more information on University of Missouri Research Reactor Center please visit: http://www.murr.missouri.edu/.
Nordion is a leading provider of medical isotopes and gamma technologies used for the prevention, diagnosis and treatment of disease and infection. Nordion’s products are used daily by pharmaceutical and biotechnology companies, medical-device manufacturers, hospitals, clinics and research laboratories. Nordion supplies products to approximately 500 customers across more than 40 countries around the globe. It is a standalone business of Sterigenics International LLC. Sterigenics International, LLC is the leading global provider of contract sterilization and lab services for the medical device industry, the world’s leading supplier of Co-60 and a leading supplier of medical isotopes. Sterigenics International, LLC is the only vertically integrated sterilization company in the world. Learn more about Nordion at nordion.com and follow us on Twitter at @NordionInc.
About General Atomics
San Diego-based General Atomics is committed to developing energy innovations and advanced technologies with world-changing potential. The scientists and engineers of GA’s Energy Group are pushing the frontier of scientific discovery to produce safe, sustainable and economic solutions to global challenges in energy, medical imaging and next generation computing. Learn more about General Atomics at GA.com.
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Saint-Genis-Pouilly, France – March 30, 2017
Advanced Accelerator Applications S.A. (NASDAQ:AAAP) (AAA or the Company), an international specialist in Molecular Nuclear Medicine (MNM), today announced a 10-year exclusive supply agreement for lutetium 177 with the University of Missouri Research Reactor (MURR®). Through this agreement, MURR® will supply AAA with GMP-quality lutetium 177 Chloride, the precursor for production of investigational product lutetium Lu 177 dotatate (Lutathera®) and other Lu 177-based therapeutics in development.
Lutetium 177 is a radionuclide that emits both high-energy beta and low-energy gamma radiation. Beta particles (electrons) are commonly used as an external radiation source to treat solid tumors, known as radiotherapy. However, in nuclear medicine, tumor killing beta particles are delivered to tumors intravenously, by labeling a targeting molecule (such as dotatate), with a radionuclide (such as lutetium 177), as in lutetium Lu 177 dotatate (Lutathera®). The targeting molecule has an affinity for certain tumor receptors, creating a rapid uptake of these molecules by the tumor cells. The beta emitting radiation of the radionuclide is treating the tumor; while the gamma emitting radiation may be visualized using specialized imaging techniques, enabling quantification of treatment delivery to tumor cells.
Ralph Butler, Executive Director of MURR® commented, “MURR® has a proud history of providing research isotopes to industry. Since the early days of targeted Lu 177 research at MURR®, our vision has been to reliably supply Lu 177 Chloride for research and ultimately produce directly for drug manufacturers. This agreement completes our vision, as we believe AAA’s breakthrough investigational product, Lutathera®, is on the verge of approval in the USA and Europe and will be widely administered to patients. The agreement also allows MURR® to continue its worldwide research collaborations using this uniquely capable isotope.”
Stefano Buono, Chief Executive Officer of AAA stated, “This agreement complements our existing supply of Lutetium 177 from our IDB subsidiary in the Netherlands, and supports our plans to produce lutetium Lu 177 dotatate (Lutathera®) for the North American market at our Millburn, NJ site. Lutetium 177’s utility in oncology therapy has been long documented and having two reliable sources uniquely positions us to expand our pipeline of lutetium 177-based therapeutics for oncology indications, and serve as a global supplier to other end users.”
About lutetium Lu 177 dotatate (Lutathera®)
Lutetium Lu 177 dotatate (Lutathera®) is an investigational, Lu-177-labeled somatostatin analog peptide currently in development for the treatment of gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including foregut, midgut, and hindgut neuroendocrine tumors in adults. Lutetium Lu 177 dotatate belongs to an emerging form of treatments called Peptide Receptor Radionuclide Therapy (PRRT), which involves targeting neuroendocrine tumors with radiolabeled somatostatin analog peptides. This novel, investigational compound has received orphan drug designation from the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Currently, lutetium Lu 177 dotatate is administered on a compassionate use and named patient basis for the treatment of NETs and other tumors over-expressing somatostatin receptors in ten European countries and in the US under an Expanded Access Program (EAP) for midgut NETs. New Drug Application and Marketing Authorization Application submissions to the FDA and EMA for lutetium Lu 177 dotatate are currently under review.
About Advanced Accelerator Applications
Advanced Accelerator Applications is an innovative radiopharmaceutical company that develops, produces and commercializes Molecular Nuclear Medicine products. AAA’s lead investigational therapeutic candidate, lutetium Lu 177 dotatate (Lutathera®), is a novel MNM compound that AAA is currently developing for the treatment of Neuroendocrine Tumors, a significant unmet medical need. Founded in 2002, AAA has its headquarters in Saint-Genis-Pouilly, France. AAA currently has 22 production and R&D facilities able to manufacture both diagnostics and therapeutic MNM products, and has more than 500 employees in 13 countries (France, Italy, UK, Germany, Switzerland, Spain, Poland, Portugal, The Netherlands, Belgium, Israel, the U.S. and Canada). AAA reported sales of €109.3 million in 2016 (+23% vs. 2015). AAA is listed on the Nasdaq Global Select Market under the ticker “AAAP”. For more information, please visit: http://www.adacap.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release may contain forward-looking statements. All statements, other than statements of historical facts, contained in this press release, including statements regarding the Company’s strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements reflect the Company's current expectation regarding future events. These forward-looking statements involve risks and uncertainties that may cause actual results, events or developments to be materially different from any future results, events or developments expressed or implied by such forward-looking statements. Such factors include, but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the timing of our submission of applications for regulatory approvals, EMA, FDA and other regulatory approvals for our product candidates, the occurrence of side effects or serious adverse events caused by or associated with our products and product candidates; our ability to procure adequate quantities of necessary supplies and raw materials for lutetium Lu 177 dotatate (Lutathera®) and other chemical compounds acceptable for use in our manufacturing processes from our suppliers; our ability to organize timely and safe delivery of our products or product candidates by third parties; any problems with the manufacture, quality or performance of our products or product candidates; the rate and degree of market acceptance and the clinical utility of lutetium Lu 177 dotatate (Lutathera®) and our other products or product candidates; our estimates regarding the market opportunity for lutetium Lu 177 dotatate (Lutathera®), our other product candidates and our existing products; our anticipation that we will generate higher sales as we diversify our products; our ability to implement our growth strategy including expansion in the U.S.; our ability to sustain and create additional sales, marketing and distribution capabilities; our intellectual property and licensing position; legislation or regulation in countries where we sell our products that affect product pricing, taxation, reimbursement, access or distribution channels; regulatory actions or litigation; and general economic, political, demographic and business conditions in Europe, the U.S. and elsewhere. Except as required by applicable securities laws, we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
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Makovsky & Company