BWXT Medical Submits Drug Master File for Actinium-225 API to U.S. Food and Drug Administration

Rhea-AI Summary

BWXT Medical has submitted a Drug Master File (DMF) to the FDA for its No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active Pharmaceutical Ingredient. Ac-225 is an alpha-emitting isotope important for targeted alpha therapies (TATs) that selectively kill cancer cells. The DMF submission highlights BWXT's commitment to quality and regulatory standards, ensuring safety and efficacy. The isotope is produced via high-energy proton spallation of thorium targets, a method developed in collaboration with TRIUMF to yield high purity Ac-225. This filing supports clinical and pharmaceutical developments, marking a significant milestone for BWXT Medical.

Positive

• BWXT Medical's submission of a DMF to the FDA is a critical regulatory milestone.
• Ac-225 is essential for targeted alpha therapies, a growing field with high demand.
• High-energy proton spallation method ensures high purity Ac-225 without long-lived impurities.
• Collaboration with TRIUMF enhances production capabilities and technological expertise.
• Submission supports later-stage clinical studies and new drug applications.

Negative

• number of suppliers for Ac-225 might pose scalability challenges.
• Dependence on high-energy proton spallation could result in high production costs.

Insights

Medical Research Analyst

BWXT Medical Ltd.'s submission of a Drug Master File (DMF) to the FDA for No Carrier Added Actinium-225 (Ac-225) represents a critical development for the company and the medical isotope sector. Ac-225 is notable for its use in targeted alpha therapies (TATs), which are emerging treatments for various cancers. The ability to target tumor cells while sparing healthy tissue is a significant advancement in oncology. Given the limited number of suppliers capable of producing high-purity Ac-225, BWXT Medical's ability to provide this isotope positions them favorably. This development can accelerate later-stage clinical studies and new drug applications, potentially expediting the delivery of innovative cancer treatments. This filing indicates not only readiness for commercialization but also a commitment to maintaining stringent quality standards.

Market Research Analyst

The submission of the DMF by BWXT Medical is particularly impactful for investors due to the increasing demand for actinium-225. The isotope's application in targeted alpha therapies (TATs) addresses a growing market need for treatments that offer precision in oncology with fewer side effects. From a business perspective, positioning BWXT Medical as a reliable supplier of high-purity Ac-225 could result in significant market share and revenue growth. Being one of the few companies capable of producing meaningful quantities of this isotope places BWXT Medical in a competitive advantage, potentially leading to lucrative partnerships and contracts with pharmaceutical companies involved in cancer treatment research and development.

Financial Analyst

The financial implications of BWXT Medical's DMF submission to the FDA are considerable. With the potential for Ac-225 to be used in later-stage clinical trials and new drug applications, this could drive significant future revenue. The market for targeted alpha therapies is expected to grow, driven by the need for more effective cancer treatments. The company's strategic alignment with TRIUMF for the production and irradiation processes further strengthens its supply chain, ensuring a steady production of high-purity Ac-225. This could result in long-term contracts and consistent revenue streams, enhancing investor confidence. However, investors should also consider the regulatory and production challenges that could impact timelines and costs.

OTTAWA, Ontario--(BUSINESS WIRE)-- BWXT Medical Ltd. has submitted a Drug Master File (DMF) to the U.S. Drug and Food Administration (FDA) for No Carrier Added (n.c.a.) Actinium-225 (Ac-225) Active Pharmaceutical Ingredient.

Ac-225 is an alpha-emitting isotope used in targeted alpha therapies (TATs) that combine the isotope with specific tumor-seeking targeting vectors to kill cancer cells while minimizing the impact to healthy tissues.

There is growing demand for the isotope, but there are a limited number of suppliers that are currently able to produce meaningful quantities of high purity actinium. One such technology is high-energy proton spallation of thorium targets that are produced and irradiated in collaboration with TRIUMF. Irradiation at high energy favors the production of Ra-225, which can be isolated and loaded onto a generator. Elution of this generator yields high purity Ac-225, which does not contain the long-lived impurity Ac-227.

Jonathan Cirtain, president and chief executive officer of BWXT Medical, stated, “Our submission of a Drug Master File to the FDA marks a significant milestone for our company. This filing underscores our unwavering commitment to quality and regulatory excellence, ensuring that our medical isotopes meet the highest standards of safety and efficacy. It represents not just our dedication to advancing healthcare, but also our readiness to support our customers and partners in delivering critical treatments to patients in need.”

The FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health. Drug master files (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 Ac-225. These forward-looking statements involve a number of risks and uncertainties, including, among other things, changes in market demand, delays in the development and automation of our 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20240606566718/en/

Media Contact

Monifa Miller

Senior Director, Corporate Affairs

Commercial Operations

519.242.8071 mamiller@bwxt.com

Investor Contact

Chase Jacobson

Vice President, Investor Relations

980.365.4300 investors@bwxt.com

Source: BWX Technologies, Inc.

FAQ

What is the significance of BWXT Medical's DMF submission for Ac-225?

The DMF submission to the FDA is a critical milestone that underscores BWXT Medical's commitment to quality and regulatory standards, supporting clinical and pharmaceutical developments.

What is Actinium-225 used for?

Actinium-225 is used in targeted alpha therapies (TATs) that selectively kill cancer cells while minimizing damage to healthy tissues.

How is Ac-225 produced by BWXT Medical?

Ac-225 is produced via high-energy proton spallation of thorium targets, a method developed in collaboration with TRIUMF, yielding high purity Ac-225.

Why is high purity Ac-225 important?

High purity Ac-225 is important for effective and safe targeted alpha therapies, as it does not contain long-lived impurities like Ac-227.

How does BWXT Medical's DMF submission impact future clinical studies?

The DMF submission enables clinical investigators and pharmaceutical companies to reference the filing in their regulatory submissions, supporting later-stage clinical studies and new drug applications.