Purdue University College of Pharmacy and NorthStar Medical Radioisotopes Announce Collaborative Agreement Expanding Nuclear Pharmacy Training Curriculum

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“We are extremely grateful for our partnership with NorthStar,” said Eric L. Barker, Ph.D. Dean, Purdue College of Pharmacy. “The Purdue College of Pharmacy has a rich tradition and legacy of preparing leaders in nuclear pharmacy. We will use the RadioGenix System to provide ‘hands-on’ laboratory-based experiences so that our student pharmacists have access to the latest advancements in radiopharmacy production techniques and are well-equipped for the professional workplace.”

“We have collaborated with NorthStar on several projects over the last few years, and we are excited to be given the opportunity to allow our students to learn about this new technology as well as experience its operation first hand,” said Kara D. Weatherman, PharmD, BCNP, FAPhA, Clinical Associate Professor of Pharmacy Practice, Director, Nuclear Pharmacy Programs, Purdue College of Pharmacy. “Our relationship with NorthStar has provided our students with a unique insight into this exciting new development in nuclear pharmacy practice, and as they move out of academia and begin practice, they are able to better understand the pivotal role that a domestic supply of Mo-99 will play in the future. In addition, our use of the NorthStar RadioGenix System provides a stable supply of Mo-99/Tc-99m that can be used for our educational and research endeavors involving our pharmacy students. It will further benefit our students as they work through our nuclear pharmacy curriculum. We look forward to further strengthening our collaboration with NorthStar in the future.”

“We are excited to collaborate with Purdue University’s prestigious College of Pharmacy in advancing educational initiatives in nuclear pharmacy,” said Stephen Merrick, President and CEO of NorthStar Medical Radioisotopes. “NorthStar is committed to delivering innovative technology solutions for the nuclear medicine community, and this cooperative effort between industry and academia provides students with experience in being part of the solution. Because the RadioGenix System uses non-uranium based molybdenum-99 (Mo-99), it ensures that radiopharmacies can have stable, reliable access to domestically produced Mo-99 to produce Tc-99m. This in turn enables reliable scheduling of procedures to meet patients’ healthcare needs in a timely manner.”

About the Purdue University College of Pharmacy

For almost 135 years, the Purdue College of Pharmacy has trained the world’s elite pharmacy leaders through acclaimed curricula, preeminent faculty and active industry partnerships. The College produces elite pharmacy leaders who are improving lives worldwide in rewarding, top-paying healthcare careers. The Purdue College of Pharmacy is consistently ranked among the top pharmacy programs in the nation.

About the RadioGenix® System

The RadioGenix System is an innovative, high tech separation platform that is approved for processing non-uranium/non-highly enriched uranium molybdenum-99 (Mo-99) for the production of the important medical radioisotope, technetium-99m (Tc-99m). Prior to availability of RadioGenix technology, the U.S. supply chain for Mo-99 has been subject to frequent and sometimes severe interruptions which negatively impact patient healthcare. Approved by the U.S. Food and Drug Administration in 2018, the RadioGenix System is the first and only on-site, automated isotope separation system of its kind for use with non-uranium/non-highly enriched uranium based Mo-99, designed to help alleviate shortage situations and expand domestic supply.

Indication and Important Risk Information about the RadioGenix® System and Sodium Pertechnetate Tc 99m Injection USP

INDICATION

The RadioGenix® System is a technetium Tc-99m generator used to produce Sodium Pertechnetate Tc 99m Injection, USP. Sodium Pertechnetate Tc 99m Injection is a radioactive diagnostic agent and can be used in the preparation of FDA-approved diagnostic radiopharmaceuticals.

Sodium Pertechnetate Tc 99m Injection is also indicated in

• Adults for Salivary Gland Imaging and Nasolacrimal Drainage System Imaging (dacryoscintigraphy).
• Adults and pediatric patients for Thyroid Imaging and Vesicoureteral Imaging (direct isotopic cystography) for detection of vesicoureteral reflux.

IMPORTANT RISK INFORMATION

• Allergic reactions (skin rash, hives, or itching) including anaphylaxis have been reported following the administration of Sodium Pertechnetate Tc 99m Injection. Monitor all patients for hypersensitivity reactions.

• Radiation risks associated with the use of Sodium Pertechnetate Tc 99m Injection are greater in children than in adults and, in general, the younger the child, the greater the risk owing to greater absorbed radiation doses and longer life expectancy. These greater risks should be taken firmly into account in all benefit-risk assessments involving children. Long-term cumulative radiation exposure may be associated with an increased risk of cancer.

• Temporarily discontinue breastfeeding. A lactating woman should pump and discard breastmilk for 12 to 24 hours after Sodium Pertechnetate Tc 99m Injection administration.

• Sodium Pertechnetate Tc 99m Injection should be given to pregnant women only if the expected benefits to be gained clearly outweigh the potential hazards.

• Only use potassium molybdate Mo-99, processing reagents, saline and other supplies, including kits, provided by NorthStar Medical Radioisotopes. Do not administer Sodium Pertechnetate Tc 99m Injection after the 0.15 microCi of Mo-99/mCi of Tc-99m limit has been reached or when the 12 hour expiration time from elution is reached, whichever occurs earlier.

To report SUSPECTED ADVERSE REACTIONS, contact NorthStar Medical Radioisotopes, LLC at 1-844-438-6659; or FDA at 1-800-332-1088 or www.fda.gov-/medwatch.

For Full RadioGenix® System Prescribing Information, click here or visit https://www.northstarnm.com/wp-content/uploads/2019/08/radiogenix-system-pi-july2019.pdf.

About NorthStar Medical Radioisotopes, LLC (NorthStar)

NorthStar Medical Radioisotopes is a nuclear medicine technology company committed to providing the United States with reliable and environmentally friendly radioisotope supply solutions to meet the needs of patients and to advance clinical research. The Company’s first product is the RadioGenix® System, an innovative and flexible platform technology initially approved by the U.S. Food and Drug Administration in February 2018 for the processing of non-uranium/non-highly enriched uranium based molybdenum-99 (Mo-99), the parent isotope of technetium-99m (Tc-99m), which is currently the most widely used diagnostic radioisotope for medical purposes. NorthStar’s proprietary and patented technologies include non-uranium based molybdenum-99 domestic production methods, patented separation chemistry systems, patented sterilization systems and a technology platform that potentially allows expanded product offerings to provide solutions in both the diagnostic and therapeutic markets. Founded in 2006 and based in Beloit, Wis., NorthStar Medical Radioisotopes, LLC is a wholly-owned subsidiary of NorthStar Medical Technologies, LLC. For more information, visit: www.northstarnm.com.

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