BWXT Medical Submits New Drug Application for Tc-99m Generator to FDA

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Company Highlights Growth of Nuclear Medicine Product Portfolio and Future Opportunities in Radioisotope Therapeutics

OTTAWA, Ontario–(BUSINESS WIRE)–$BWXT–BWX Technologies, Inc. (NYSE: BWXT) today announced that its subsidiary BWXT Medical Ltd. has submitted a New Drug Application to the United States Food and Drug Administration (FDA) seeking approval of its technetium-99m (Tc-99m) generator for diagnostic imaging.

Once approved for commercial production by regulatory agencies, BWXT Medical’s new proprietary manufacturing technology will be used to irradiate molybdenum targets in an Ontario Power Generation reactor, process Mo-99 (the parent isotope of Tc-99m) and then incorporate the material into Tc-99m generators at BWXT Medical’s facility in Kanata, Ontario, for delivery to radiopharmacies and hospitals in the United States and Canada.

Tc-99m is used in over 40 million diagnostic procedures per year and is the daughter isotope of molybdenum-99 (Mo-99). Historically, Mo-99 was produced in research reactors using uranium as a feedstock. Alternatively, the BWXT Tc-99m generator will be produced from irradiated natural molybdenum targets in a commercial power reactor, significantly reducing complex waste byproducts. These targets are processed into the finished active pharmaceutical ingredient and then loaded into generators that have the function and shape of generators already used in radiopharmacies and hospitals today.

“We are thrilled to reach this key milestone for BWXT Medical, bringing us one step closer to our aspiration for global leadership in nuclear drug manufacturing,” said Rex D. Geveden, President and CEO of BWXT. “Our Tc-99m generator product is a lower cost and more reliable replacement for current generators, and we view it as a key part of our medical portfolio.”

“BWXT’s comprehensive, multi-year R&D campaign not only results in a foundational product line for the company, but also in the delivery of a crucial diagnostic drug that supports the health of millions of people,” said Dr. Jonathan Cirtain, President. and CEO of BWXT Medical. “Beyond Tc-99m, I am excited to lead BWXT Medical through a compelling set of growth opportunities, including indications of early success driven by breakthroughs in therapeutic nuclear medicine.”

“Our multi-faceted growth strategy is focused on commercializing our Tc-99m generator, expanding our core cGMP-grade isotope and finished pharmaceutical business, and providing new therapeutic radioisotopes. and sterile drug products to meet the significant growing demand for these innovative therapies,” said Dr. Cirtain.

BWXT posted a presentation in the Investor Relations section of its website about BWXT Medical. The presentation highlights the subsidiary’s Tc-99m generator strategy, growing portfolio of nuclear medicine products and exciting future opportunities in radioisotope therapeutics. The presentation can be found here.

Forward-looking statements

BWXT cautions that this release contains forward-looking statements, including statements relating to the production, performance, timing, impact and value of Tc-99m and changes in demand, benefits and applicability of Tc-99m. These forward-looking statements involve a number of risks and uncertainties, including, among others, changes in market demand, delays and the commercialization of our production of Tc-99m; our ability to obtain necessary regulatory approvals, licenses and permits on a timely basis; the ability to market that product; competition in an environment of rapid technological change; and the enforcement and protection of our intellectual property rights. If one or more of these or other risks materialize, actual results may differ materially from those expressed. For a more complete discussion of these and other risk factors, please see BWXT’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. BWXT cautions not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and undertakes no obligation to update or revise any forward-looking statement, except as required. by applicable law.

About BWXT

At BWX Technologies, Inc. (NYSE: BWXT), we are strong, innovation-driven people. Based in Lynchburg, Va., BWXT is a Fortune 1000 and Defense News Top 100 manufacturing and engineering innovator that provides safe and effective nuclear solutions for global security, clean energy, environmental sanitation environment, nuclear medicine and space exploration. With approximately 6,700 employees, BWXT has 14 major operating sites in the United States, Canada and the United Kingdom. In addition, BWXT joint ventures manage and operate more than a dozen US Department of Energy and NASA facilities. Follow us on Twitter at @BWXT and learn more about www.bwxt.com.

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Nathalie Coutier

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