NorthStar Medical Radioisotopes, LLC Announces Business Update and Commercial Progress on RadioGenix® System Launch
– Positive RadioGenix System market momentum continues –
– Increasing weekly domestic production of non-uranium based Mo-99 –
- Strategically-planned RadioGenix System roll out on track; initial units in use
- Numerous RadioGenix System commercial sites in regulatory licensure review process; many additional sites anticipated in 2019
- Every week, an increasing number of technetium-99m (Tc-99m) patient doses are dispensed using RadioGenix Systems and non-uranium molybdenum-99 (Mo-99)
- NorthStar recognized by U.S. Department of Energy’s National Nuclear Security Administration as first producer of Mo-99 in the United States in nearly 30 years
- FDA approval of Beloit, Wis. cGMP facility for RadioGenix System manufacturing marks initial step to increasing production capacity of domestic Mo-99
- Executive team leadership now structured to accelerate growth as a fully commercialized company
BELOIT, Wis. – February 5, 2019 – NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radioisotopes used for medical imaging, today announced a corporate update highlighting the continued commercial progress of its RadioGenix System following U.S. Food and Drug Administration (FDA) approval in February, 2018. NorthStar’s RadioGenix System is an innovative, high tech radioisotope separation platform indicated for use in producing the widely used medical radioisotope technetium-99m (Tc-99m) from non-uranium based molybdenum-99 (Mo-99).
“The 12 months since FDA approval of the RadioGenix System and domestic Mo-99 have been pivotal for NorthStar successfully executing on our carefully planned strategy for roll out into the commercial marketplace and advancing our commitment to provide the U.S. healthcare system with a reliable, domestic, non-uranium based Mo-99 supply for production of the important medical diagnostic imaging radioisotope, Tc-99m,” said Stephen Merrick, President and Chief Executive Officer of NorthStar. “With the RadioGenix System on the market, NorthStar has commercialized the first innovative technology for production of domestic Mo-99 in nearly 30 years, and we continue to execute upon our carefully staged launch of the product. Every week, a significant and growing number of Tc-99m patient doses are dispensed using RadioGenix Systems and non-uranium Mo-99, with market uptake continuing to be strong and growing. The U.S. need for secure domestic Mo-99 supply was underscored recently, when RadioGenix Systems enabled our customers to provide Tc-99m for patients during a severe Mo-99 supply shortage incurred by multiple overseas production outages.”
Mr. Merrick continued, “We look forward to achieving significant success in the coming year as a fully sustainable, commercialized enterprise, with a focus to implement additional RadioGenix System enhancements and expand production capacity for non-uranium based Mo-99. Construction on our 20,000 square foot facility expansion in Beloit, Wis. is well underway, which we anticipate will more than double production capacity for Mo-99 Source Vessels upon completion and FDA approval. Additionally, we are working toward final validation of two state-of-the-art fill lines at our Columbia, Mo. facility that, pending expected FDA approval this year, will increase the number of Mo-99 Source Vessels we are able to ship weekly. We are further planning for the future by investing in additional Mo-99 production capacity and enhancements to the RadioGenix System, and we will provide updates on these plans as they progress. Finally, I want to recognize the tremendous job our partners at MURR have done to help ensure that Mo-99/Tc-99m is available for Radiopharmacies, HealthCare Providers, and, most importantly, patients.”
NorthStar is making important progress in achieving its vision to become a leading medical radioisotope production company:
RadioGenix System Commercial Progress
NorthStar continues to successfully implement its carefully staged launch of the RadioGenix System.
- Commercial RadioGenix Systems are on the market, providing the medically important diagnostic radioisotope, technetium-99m (Tc-99m) from domestically produced, non-uranium based molybdenum-99 (Mo-99), with positive customer feedback.
- Numerous customer sites are in the licensure amendment process, with many further placements planned in 2019.
- Every week, a significant number of Tc-99m doses are being dispensed using RadioGenix Systems, with market uptake continuing to be strong and growing. Domestic, non-uranium based Mo-99 used in RadioGenix Systems helped alleviate the severe November, 2018 supply shortage precipitated by multiple overseas supplier outages.
- In recognition of FDA approval of the RadioGenix System and domestic Mo-99, NorthStar received an Award for Outstanding Achievement from the U.S. Department of Energy’s National Nuclear Security Administration as the first producer of molybdenum-99 (Mo-99) in the United States in nearly 30 years.
Initiatives to Increase Mo-99 Manufacturing and Production Capacity
In its efforts to support increased Mo-99 production capacity, NorthStar is expanding its cGMP manufacturing capabilities and overall footprint in Beloit, Wis.
- The U.S. Food and Drug Administration (FDA) approved the Company’s Beloit, Wis. facility for manufacture of RadioGenix Systems and associated components, marking a first step in NorthStar’s efforts to expand Mo-99 production capacity to meet anticipated customer demand.
- Construction is well underway on NorthStar’s 20,000 square foot facility expansion in Beloit, which is planned to more than double its capacity to fill Mo-99 Source Vessels, once dissolution and filling equipment is installed, qualified, validated and then FDA approved.
- NorthStar is nearing final validation of two state-of-the-art Source Vessel filling systems at its facility in Columbia, Mo. that, pending FDA approval, will immediately increase the number of Mo-99 Source Vessels available for shipment weekly.
- NorthStar continues to expand organizationally, currently employing more than 160 highly trained professionals to advance its efforts.
Executive Team Alignment to Further Drive Commercial Growth
NorthStar‘s expanded and aligned executive team brings global commercialization and financial expertise to lead the company as a fully sustainable organization.
- Appointed Stephen Merrick as President and Chief Executive Officer. Mr. Merrick has been with NorthStar since March 2016, initially in the role of Chief Operating Officer and later as President and Chief Operating Officer. He possesses broad executive experience in the pharmaceutical industry at Bristol-Myers Squibb, Mallinckrodt and Baxter Healthcare, and expertise in product development and driving domestic and global market demand. Mr. Merrick served as Vice President, International Marketing for Baxter International’s Hospital Products business and prior to that, he was Senior Vice President and President – International Commercial Operations for Mallinckrodt Pharmaceuticals. He previously worked in management at Bristol-Myers Squibb for 17 years in positions of increasing responsibility and began his corporate career with Eli Lilly and Company.
- Appointed Paul Estrem, CPA, as Senior Vice President and Chief Financial Officer. Mr. Estrem holds financial responsibility for the operations of NorthStar and has relevant financial experience in the life science and medical technology industries. He served as CFO at Melinta Therapeutics, Inc. where he guided the company in converting from a private to public enterprise, raised more than $500 million in support of the company, assisted in product acquisitions, facilitated a merger and supported the commercial launch of multiple products. Previously, he was with Baxter International, Inc., where he held both financial and non-financial positions of increasing responsibility, including roles as divisional CFO for various divisions, CFO of Baxter’s operations in Japan and serving as the Vice-President of Integration for a large acquisition. Mr. Estrem was previously a public accountant with Arthur Andersen & Co.
- Appointed Dave Wilson as Vice President, Operations. Mr. Wilson has been with NorthStar for more than three years, initially in the roles of Director of Isotope Processing and Director of Manufacturing. His expertise in creating and implementing successful operational programs in rapidly growing radiopharmaceutical businesses provides a valuable resource for NorthStar. Previously he was Vice President, PET & SPECT Pharmacy Operations for Triad Isotopes, where he oversaw daily operations of its southeastern U.S. radiopharmacies and led all its PET manufacturing sites through several FDA approvals, including F-18 FDG and F-18 NaF. Prior to that, at PETNET Solutions, a Siemens company, Mr. Wilson led multi-disciplinary teams in a dynamic growth environment to establish new PET isotope manufacturing centers across the United States. He is a Board Certified Nuclear Pharmacist and holds a Bachelor of Science in Pharmacy from the St. Louis College of Pharmacy.
- Appointed Diane Hendricks as Chairperson of the Board. Diane Hendricks has served on the Board of Managers of NorthStar since November 2011, and was elected Chairperson of the Board in September 2018. Diane has been actively engaged in guiding and supporting NorthStar since the initial investment by Hendricks Holding Company, Inc. (“HHC”) in 2011. Diane is the Chairperson of the Board of HHC, which owns a diverse portfolio of domestic and international manufacturing, distribution, service and life sciences companies including NorthStar. Diane is also chairperson of ABC Supply Co., Inc., the company she co-founded with her late husband, Ken Hendricks. Headquartered in Beloit, Wisconsin, ABC Supply is the largest wholesale distributor of exterior building products in the United States. ABC distributes roofing, siding, windows, and other select exterior building products to professional contractors. As a result of the acquisition of L&W Supply, ABC is now one of the largest wholesale distributors of drywall in the U.S. ABC was founded in 1982 and has been the recipient of the Gallup Great Workplace Awards the last twelve consecutive years, which honors the most engaged and productive workforces in the world.
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 based 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 February 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.
Indication and Important Risk Information About the RadioGenix® System and Sodium Pertechnetate Tc 99m Injection USP
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, visit https://www.northstarnm.com/wp-content/uploads/2018/04/PI_Rev04_23mar2018.pdf.
About Medical Radioisotopes – Molybdenum-99 (Mo-99) and Technetium-99m (Tc-99m)
Tc-99m is a radioisotope used in a variety of diagnostic testing procedures. It is currently the most widely used medical radioisotope in the United States, used in more than 10 million diagnostic procedures annually. Tc-99m-based radiopharmaceuticals are used to diagnose and stage heart disease, cancer, infection, inflammation and other conditions.
Tc-99m is derived from the radioisotope Mo-99. The United States uses about 50% of the world’s Mo-99/Tc-99m for medical purposes, but U.S. supply of Mo-99 has been completely reliant on foreign sources and subject to frequent and sometimes protracted interruptions which negatively impact patient healthcare. Other Mo-99 producers continue to use enriched uranium in their processing which poses significant environmental concerns. NorthStar’s technology uses stable isotopes of molybdenum to produce Mo-99 domestically without incurring the concerns related to the management of toxic waste associated with Mo-99 production from enriched uranium.
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.
For NorthStar Medical Radioisotopes, LLC
Vice President Sales and Marketing
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