Company Provides Progress Update as Facility Construction Gets Underway
BWX Technologies, Inc. (NYSE: BWXT) announced today that it has successfully labeled technetium-99m (Tc-99m) derived from its proprietary molybdenum-99 (Mo-99) production process and its proprietary Tc-99m generators with nine of the most widely used cold kits in the North American market.
s the company announced in 2018, BWXT’s proprietary technology features a neutron capture process to produce Mo-99 using natural molybdenum rather than enriched uranium targets. The proprietary process will mitigate radioactive waste streams and nuclear proliferation concerns and will significantly reduce production and waste costs relative to current market participants. BWXT-designed Tc-99m generators are intended to be drop-in replacements for those used in radiopharmacies in North America every day.
“BWXT will produce Mo-99 and Tc-99m generators entirely in North America without reliance on overseas suppliers,” said Rex Geveden, BWXT’s president and chief executive officer. “Our superior technology will improve continuity of supply for this vital diagnostic tool at a lower cost. Previous internal testing had proven that our technology meets the generic product specifications, and these latest results showed that our technology will be a drop-in replacement for existing generators.”
Cold Kit Labeling
In January, BWXT demonstrated its ability to successfully label Tc-99m cold kits. Labeling is a process in which Tc-99m eluted from a generator is combined with a chemical reagent (known as a “cold kit”) to produce a radiopharmaceutical for use with a patient.
The successfully labeled kits included bicisate, exametazime, macroaggregated albumin, mebrofenin, medronate, mertiatide, sestamibi, sulfur colloid and tetrofosmin. These kits cover the vast majority of the volume for Tc-99m in the North American market today, and the ability to successfully label them is viewed as a critical step toward regulatory and commercial market acceptance for BWXT’s Tc-99m generator. The testing demonstrated that all quality control verification requirements, such as molybdenum breakthrough and thin layer chromatography testing, will be achievable with BWXT’s generators.
Dr. Mihaela Ginj, the radiopharmacy operations lead at Toronto General Hospital, part of the University Health Network, observed some of BWXT’s testing and labeling process. “I had the opportunity to spend half a day at BWXT and see several generators eluted and cold kits labeled, and then tested,” said Ginj. “I’m encouraged by this technology and its ability to fit into the existing radiopharmacy and nuclear medicine infrastructure. It allows me to be optimistic about a more diversified and reliable Mo-99 supply for nuclear medicine professionals and patients in North America.’’
Development / Construction Activities and Schedule
BWXT has completed a number of development activities as it progresses toward scaling up its manufacturing capacity, including target and target delivery system design, production technology development, development of quality assurance/quality control methods, and finalization of facility designs. BWXT is currently engaged in facility construction and modification.
Once the production facility and target delivery system are substantially complete, BWXT expects to submit a new drug application filing with the U.S. Food and Drug Administration. Due to delays in the Mo-99 project, we are re-baselining the program schedule and expect to provide updates as appropriate.
BWXT’s progress has been substantially supported by the 2018 acquisition of the Nordion medical isotope business. The acquisition added approximately 150 highly trained and experienced personnel, two specialized production centers and a uniquely licensed infrastructure.
BWXT recently entered into a reactor services agreement with the University of Missouri. Under the terms of the agreement, the University will irradiate proprietary BWXT targets in the Missouri University Research Reactor (MURR) for use by BWXT in production of Mo-99. MURR provided the irradiated targets that BWXT used in its successful Tc-99m cold kit labeling.
“We take this role in meeting patient needs very seriously, and we are fortunate in Missouri to have such a well-designed reactor and an outstanding staff,” said Dave Robertson, executive director of MURR. “MURR has worked with key individuals at BWXT for more than 25 years, and we are proud to be involved in this unique project that will become an important source of Mo-99.”
As previously announced, BWXT plans for irradiation services to be done primarily at Darlington Nuclear Generating Station by Laurentis Energy Partners, a wholly owned subsidiary of Ontario Power Generation (OPG). Irradiation services from MURR will be utilized for testing, validation and development of BWXT’s new production line, and also to augment the work to be performed at Darlington as required.
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, benefit and applicability of Tc-99m. These forward-looking statements involve a number of risks and uncertainties, including, among other things, changes in market demand for, delays in and commercialization of our Tc-99m production; our ability to obtain the necessary regulatory approvals, licenses and permits in a timely manner or at all; the ability to commercialize this 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 vary 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, 2019 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 to the extent required by applicable law.