BWXT Medical and NorthStar Medical Radioisotopes Sign Supply Agreement Supporting Actinium-225 Production
BWXT Medical and NorthStar Medical Radioisotopes have signed a Master Services Agreement (MSA) to collaborate on the production of actinium-225 (Ac-225), a critical medical isotope used in cancer treatments. The multi-year agreement focuses on processing and purifying radium-226, with potential for target design projects and backup supply opportunities.
This collaboration aims to streamline production processes, enhance safety protocols, and innovate new methods of isotope generation. BWXT Medical recently submitted a Drug Master File (DMF) for Actinium-225 API to the FDA, enabling clinical investigators and pharmaceutical companies to reference it in their regulatory submissions. The partnership is expected to accelerate radium-226 target design and fabrication efforts, expanding Ac-225 production capabilities.
BWXT Medical e NorthStar Medical Radioisotopes hanno firmato un Accordo Quadro di Servizi (MSA) per collaborare nella produzione di actinio-225 (Ac-225), un isotopo medico fondamentale utilizzato nei trattamenti contro il cancro. L'accordo pluriennale si concentra sulla lavorazione e purificazione del radon-226, con potenzialità per progetti di design dei target e opportunità di fornitura di emergenza.
Questa collaborazione ha l'obiettivo di semplificare i processi produttivi, migliorare i protocolli di sicurezza e innovare nuovi metodi di generazione di isotopi. BWXT Medical ha recentemente presentato un Drug Master File (DMF) per l'API di Actinio-225 alla FDA, consentendo a investigatori clinici e aziende farmaceutiche di fare riferimento ad esso nelle loro presentazioni regolatorie. Ci si aspetta che la partnership acceleri gli sforzi nella progettazione e fabbricazione dei target di radium-226, espandendo le capacità di produzione di Ac-225.
BWXT Medical y NorthStar Medical Radioisotopes han firmado un Acuerdo Marco de Servicios (MSA) para colaborar en la producción de actinio-225 (Ac-225), un isótopo médico crítico utilizado en tratamientos contra el cáncer. El acuerdo multianual se centra en el procesamiento y purificación de radio-226, con potencial para proyectos de diseño de objetivos y oportunidades de suministro de respaldo.
Esta colaboración tiene como objetivo simplificar los procesos de producción, mejorar los protocolos de seguridad e innovar en nuevos métodos de generación de isótopos. BWXT Medical ha presentado recientemente un Drug Master File (DMF) para el API de Actinio-225 a la FDA, permitiendo a los investigadores clínicos y a las empresas farmacéuticas hacer referencia a él en sus presentaciones regulatorias. Se espera que la asociación acelere los esfuerzos en el diseño y fabricación de objetivos de radio-226, ampliando las capacidades de producción de Ac-225.
BWXT Medical과 NorthStar Medical Radioisotopes가 마스터 서비스 계약(MSA)에 서명하여 악티늄-225(Ac-225)의 생산을 협력하기로 했습니다. 이는 암 치료에 사용되는 중요한 의료 동위원소입니다. 이 다년 계약은 라듐-226의 처리 및 정제에 중점을 두며, 목표 설계 프로젝트 및 백업 공급 기회의 잠재성을 가지고 있습니다.
이번 협력은 생산 프로세스를 간소화하고 안전 프로토콜을 강화하며 동위원소 생성의 새로운 방법을 혁신하는 것을 목표로 합니다. BWXT Medical은 최근 악티늄-225 API에 대한 약물 마스터 파일(DMF)을 FDA에 제출하여 임상 연구자 및 제약 회사가 규제 제출에서 이를 참조할 수 있게 했습니다. 이 파트너십은 라듐-226 목표 설계 및 제작 노력을 가속화하고 Ac-225 생산 능력을 확장할 것으로 기대됩니다.
BWXT Medical et NorthStar Medical Radioisotopes ont signé un Contrat Cadre de Services (CSA) pour collaborer à la production de actinium-225 (Ac-225), un isotope médical essentiel utilisé dans les traitements du cancer. Le contrat pluriannuel se concentre sur le traitement et la purification du radium-226, avec un potentiel pour des projets de conception de cibles et des opportunités de fourniture de secours.
Cette collaboration vise à simplifier les processus de production, à renforcer les protocoles de sécurité et à innover de nouvelles méthodes de génération d'isotopes. BWXT Medical a récemment soumis un Dossier Maître de Médicament (DMM) pour l'API d'Actinium-225 à la FDA, permettant aux enquêteurs cliniques et aux entreprises pharmaceutiques de s'y référer dans leurs soumissions réglementaires. Le partenariat devrait accélérer les efforts de conception et de fabrication des cibles de radium-226, élargissant les capacités de production d'Ac-225.
BWXT Medical und NorthStar Medical Radioisotopes haben eine Master-Service-Vereinbarung (MSA) unterzeichnet, um bei der Produktion von Actinium-225 (Ac-225), einem kritischen medizinischen Isotop zur Behandlung von Krebs, zusammenzuarbeiten. Die mehrjährige Vereinbarung konzentriert sich auf die Verarbeitung und Reinigung von Radium-226, mit Potenzial für Zieldesignprojekte und Backup-Liefermöglichkeiten.
Diese Zusammenarbeit zielt darauf ab, die Produktionsprozesse zu rationalisieren, Sicherheitsprotokolle zu verbessern und innovative Methoden der Isotopengenerierung zu entwickeln. BWXT Medical hat kürzlich einen Drug Master File (DMF) für Actinium-225 API bei der FDA eingereicht, sodass klinische Prüfer und Pharmaunternehmen darauf in ihren regulatorischen Einreichungen verweisen können. Die Partnerschaft wird voraussichtlich die Bemühungen bei der Gestaltung und Herstellung von Radium-226-Zielen beschleunigen und die Produktionskapazitäten von Ac-225 erweitern.
- Signing of a multi-year Master Services Agreement for Ac-225 production
- Potential for expanded production capabilities and backup supply opportunities
- Submission of Drug Master File for Actinium-225 API to FDA
- BWXT Medical's Ac-225 has been used in an early clinical study
- None.
Insights
The partnership between BWXT Medical and NorthStar Medical Radioisotopes signifies a considerable leap in the production and supply of Actinium-225 (Ac-225). Ac-225 is a highly sought-after isotope in targeted alpha therapy, which is a cutting-edge cancer treatment method. By combining their expertise, these companies can expedite the availability of Ac-225 for clinical trials and commercial use, potentially accelerating the development of new cancer therapies. This collaboration addresses a important gap in the radiopharmaceutical supply chain, ensuring a more reliable and scalable production of Ac-225, which could ultimately enhance patient outcomes and broaden the scope of available cancer treatments.
From a market perspective, this agreement is pivotal. The demand for radiopharmaceuticals, particularly those used in cancer treatment, is on the rise. By securing a multi-year supply agreement, BWXT Medical and NorthStar are positioning themselves as key players in this expanding market. This strategic move not only stabilizes their supply chain but also enables them to meet the growing demand efficiently. The submission of a Drug Master File (DMF) for Ac-225 to the FDA by BWXT Medical further strengthens their competitive advantage, as it facilitates regulatory compliance and enhances their credibility in the pharmaceutical industry. Such developments are likely to boost investor confidence and potentially drive the stock prices of these companies upwards.
Financially, the Master Services Agreement (MSA) between BWXT Medical and NorthStar Medical Radioisotopes is a strategic move that could result in substantial revenue growth for both firms. The production and commercialization of Ac-225, a high-value isotope, could significantly enhance their profitability. Furthermore, the ability to provide backup supply for each other's customers mitigates supply chain risks and ensures steady revenue streams. The financial implications of this partnership are profound, as it not only strengthens the operational capabilities of both firms but also opens up new streams of income through collaborative projects and innovations in isotope generation. Investors should view this as a positive development with the potential for long-term financial benefits.
- Multi-year supply agreement for radium-226 processing and purification
- Collaboration will work to provide Ac-225 for clinical trials and commercial supply
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. 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
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
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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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
Source: BWX Technologies, Inc.
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