NorthStar Medical Radioisotopes and BWXT Medical Sign Supply Agreement Supporting Actinium-225 Production
22 Julio 2024 - 6:00AM
Business Wire
- Multi-year supply agreement for radium-226 processing and
purification
- Collaboration will work to provide Ac-225 for clinical trials
and commercial supply
NorthStar Medical Radioisotopes, LLC (NorthStar) and BWXT
Medical Ltd., a subsidiary of BWX Technologies, Inc. (NYSE: BWXT)
today announced that they have signed a Master Services Agreement
(MSA), which will facilitate the production of actinium-225
(Ac-225), a critical medical isotope used to kill cancer cells
while minimizing the impact to healthy tissues.
Medical isotopes are essential for a wide range of diagnostic
and therapeutic procedures, including cancer treatments and
advanced imaging techniques. Pursuant to the multi-year MSA, the
companies will work together to process and purify radium-226 that
will be irradiated to produce Ac-225. The scope of the agreement
also includes potential target design projects and exploration of
opportunities to provide backup supply to each other’s
customers.
Jonathan Cirtain, president and chief executive officer of BWXT
Medical, stated, “We are pleased to enter into this agreement with
NorthStar. This collaboration is a significant step forward in our
mission to support healthcare providers and patients by providing
high-quality medical isotopes. Together, we are accelerating our
radium-226 target design and fabrication efforts and establishing
another irradiation relationship that will enable us to expand our
production of Ac-225.”
BWXT Medical will collaborate closely with NorthStar, a global
innovator in the development, production and commercialization of
radiopharmaceuticals used for therapeutic applications and medical
imaging, to streamline production processes, enhance safety
protocols and innovate new methods of isotope generation. This
collaboration will leverage the strengths of both organizations,
combining cutting-edge technology with extensive industry
knowledge.
“At NorthStar, we believe we’re on the cusp of a global paradigm
shift in the development and commercialization of effective new
radiodiagnostics and radiotherapies that can potentially be applied
to devastating cancers and rare, complex conditions,” said Dr.
Frank Scholz, NorthStar’s president and chief executive officer.
“This agreement could be instrumental to the radiopharmaceutical
industry and patient health. We are excited to collaborate with
BWXT on actinium production and believe our complementary technical
capabilities will play a critical role in bringing novel therapies
to patients who so urgently need them.”
BWXT Medical recently announced that it has submitted a Drug
Master File (DMF) for Actinium-225 API to U.S. Food and Drug
Administration (FDA). DMFs are submissions to FDA used to provide
confidential, detailed information about facilities, processes or
articles used in the manufacturing, processing, packaging and
storing of human drug products.
An active DMF enables clinical investigators or pharmaceutical
companies to reference the filing in their regulatory submissions.
BWXT Medical’s Ac-225 has been used in an early clinical study, and
the DMF is now ready for reference to support later stage clinical
studies and, ultimately, new drug applications.
Forward-Looking Statements BWX Technologies, Inc.
(“BWXT”) cautions that this release contains forward-looking
statements, including statements relating to expectations for the
development, production, performance, demand, timing and impact of
Radium-226, Ac-225 and related radioisotopes. These forward-looking
statements involve a number of risks and uncertainties, including,
among other things, changes in market demand, delays in the
development and production, regulatory approvals and potential
supply chain issues. 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, 2023 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 Medical BWXT Medical Ltd. manufactures custom
radiopharmaceuticals, radiotherapies and medical isotopes in an
80,000-square-foot cGMP manufacturing facility in Ottawa and at the
state-of-the-art commercial cyclotron facility within TRIUMF,
Canada’s particle acceleration centre. BWXT Medical Ltd. is a
subsidiary of BWX Technologies, Inc. (NYSE: BWXT). BWXT is a
manufacturing and engineering innovator that provides safe and
effective nuclear solutions for global security, clean energy,
environmental restoration, nuclear medicine and space exploration.
Learn more at www.bwxtmedical.com and follow us on LinkedIn.
About NorthStar Medical Radioisotopes, LLC (NorthStar)
NorthStar Medical Radioisotopes is a commercial-stage
radiopharmaceutical company at the forefront of advancing patient
care by utilizing novel technologies to produce commercial-scale
radioisotopes that, once attached to a molecule, have the ability
to detect and treat cancer and other serious diseases. NorthStar’s
expanding industry-leading position in the emerging field of
radiopharmaceutical therapy is supported by its unique capabilities
in the sophisticated production of radioisotopes, proven management
team, and state-of-the-art, environmentally preferable
technologies. NorthStar routinely produces copper-67 (Cu-67) and is
poised to be the first commercial-scale producer of
non-carrier-added (n.c.a.) actinium-225 (Ac-225). The Company’s
Radiopharmaceutical Contract Development and Manufacturing
Organization (CDMO) services unit provides customized service
offerings and specialized radiopharmaceutical expertise to help
biopharmaceutical companies rapidly advance their development and
commercial programs. For more information about NorthStar’s
comprehensive portfolio and patient-focused services, visit:
www.northstarnm.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20240722747398/en/
Media Contact: BWXT Monifa Miller Senior Director,
Corporate Affairs Commercial Operations 519.242.8071
mamiller@bwxt.com
Investor Contact: BWXT Chase Jacobson Vice President,
Investor Relations 980.365.4300 investors@bwxt.com
Media Contact: NorthStar Medical Radioisotopes, LLC
Alison Hess Vice President, Chief of Staff 608-295-9806
ahess@northstarnm.com
Investor Relations: NorthStar Paul Estrem Executive Vice
President and Chief Financial Officer 608-987-8318
pestrem@northstarnm.com