BWXT Medical Submits Tc-99m Generator New Drug Application to FDA
September 13 2022 - 4:05PM
Business Wire
Company Highlights Growing Nuclear Medicine
Product Portfolio and Future Opportunities in Therapeutic
Radioisotopes
BWX Technologies, Inc. (NYSE: BWXT) announced today that
subsidiary BWXT Medical Ltd. has submitted a new drug application
to the U.S. Food and Drug Administration (FDA) to request approval
of its technetium-99m (Tc-99m) generator for diagnostic
imaging.
Once approved for commercial production by regulatory bodies,
BWXT Medical’s new proprietary manufacturing technology will be
used to irradiate molybdenum targets at an Ontario Power Generation
reactor, process Mo-99 (the parent isotope of Tc-99m) and
subsequently incorporate material into Tc-99m generators at BWXT
Medical’s Kanata, Ontario facility for delivery to radiopharmacies
and hospitals across the United States and Canada.
Tc-99m is used in over 40 million diagnostic procedures
annually, and is the daughter isotope of molybdenum-99 (Mo-99).
Historically Mo-99 has been produced within research reactors using
uranium as a starting material. Alternatively, the BWXT Tc-99m
generator will be produced from natural molybdenum targets
irradiated at a commercial power reactor, greatly reducing complex
waste by-products. These targets are processed into the finished
active pharmaceutical ingredient and then loaded into generators
that have the function and form of generators already used at
radiopharmacies and hospitals today.
“We are excited to reach this key milestone for BWXT Medical,
putting us one step closer toward our aspiration of global
leadership in nuclear medicine manufacturing,” said Rex D. Geveden,
BWXT’s president and chief executive officer. “Our Tc-99m generator
product is a lower cost, more reliable, drop-in replacement to
current generators, and we see it as a key component of our medical
portfolio.”
“BWXT’s multi-year, comprehensive R&D campaign is resulting
in not only a foundational product line for the business, but also
in the delivery of a crucial diagnostic drug product that supports
the health of millions of people,” said Dr. Jonathan Cirtain,
president and chief executive officer of BWXT Medical. “Beyond
Tc-99m, I am excited to lead BWXT Medical through a compelling set
of growth opportunities including early success indications driven
by breakthroughs in therapeutic nuclear medicine.”
“Our multi-faceted growth strategy is focused on commercializing
our Tc-99m generator, expanding our base business of cGMP-quality
isotopes and finished drug products, and providing new therapeutic
radioisotopes and sterile drug products to address significant
growing demand for these innovative therapies,” said Dr.
Cirtain.
BWXT has published a presentation on the Investor Relations
section of its website about BWXT Medical. The presentation
highlights the subsidiary’s Tc-99m generator strategy, its growing
nuclear medicine product portfolio and exciting future
opportunities in therapeutic radioisotopes. 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, 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; 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, 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 to the extent required
by applicable law.
About BWXT
At BWX Technologies, Inc. (NYSE: BWXT), we are People Strong,
Innovation Driven. Headquartered in Lynchburg, Virginia, 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 remediation, nuclear
medicine and space exploration. With approximately 6,700 employees,
BWXT has 14 major operating sites in the U.S., Canada and the U.K.
In addition, BWXT joint ventures provide management and operations
at more than a dozen U.S. Department of Energy and NASA facilities.
Follow us on Twitter at @BWXT and learn more at www.bwxt.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20220913005952/en/
Media Contact Natalie Cutler Director, Canadian
Communications & Government Relations 519.620.5288
nacutler@bwxt.com
Investor Contact Mark Kratz Vice President, Investor
Relations 980.365.4300 investors@bwxt.com
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