Orano Med Opens Europe’s First Lead-212 Alpha Therapy Production Facility

Orano Med Inaugurates ATLab Valenciennes, Europe’s First Industrial-Scale Facility for Lead-212 Targeted Alpha Therapies

Orano Med, a subsidiary of the Orano Group and a pioneer in targeted alpha therapies for cancer, has inaugurated ATLab Valenciennes, an industrial-scale pharmaceutical manufacturing facility dedicated to the production of lead-212-based radioligand therapies. Located in Onnaing, France, the new facility is designed to support the large-scale production and distribution of a new generation of targeted cancer treatments across Europe.

The inauguration marks an important step in Orano Med’s strategy to establish an integrated industrial platform capable of supporting the development and future commercialization of targeted alpha therapies. The opening ceremony brought together Claude Imauven, Chairman of the Board of Directors of Orano; Nicolas Maes, CEO of Orano; Frederic Desdouits, CEO of Orano Med; company partners; key stakeholders; and official representatives.

ATLab Valenciennes is intended to address one of the central manufacturing and logistical challenges associated with lead-212-based therapies: the short radioactive half-life of the isotope. With a half-life of approximately 10.6 hours, lead-212-based treatments must move rapidly through production, transportation and clinical administration.

The facility has been specifically designed around these requirements, providing Orano Med with a strategically located European manufacturing base that can supply hospitals within the necessary timeframe.

New Manufacturing Platform for Targeted Alpha Therapies

Targeted alpha therapies are an emerging class of cancer treatments that combine a tumor-targeting molecule with an alpha-emitting radioactive isotope. The targeting component is designed to recognize specific biological features associated with cancer cells, while the radioactive payload delivers highly localized radiation intended to damage targeted tumor cells.

Orano Med is developing therapies based on lead-212, an alpha-emitting radioisotope that can be incorporated into targeted radioligand therapies. The company is building manufacturing capabilities around the isotope as it advances its clinical development programs and prepares for potential future demand.

ATLab Valenciennes will enable these therapies to be produced at industrial scale. In the medium term, the facility is expected to have the capacity to produce up to 10,000 doses per year, with production potential capable of being multiplied by five when the site reaches full capacity.

The scale of the facility reflects the company’s expectation that targeted alpha therapies could become an increasingly important component of oncology treatment, particularly in cancer types where patients continue to face significant unmet medical needs.

The manufacturing infrastructure is also intended to provide flexibility as Orano Med’s clinical pipeline advances and additional therapies move through development.

€29 Million Investment in French Manufacturing

ATLab Valenciennes covers more than 3,000 square meters and represents an investment of approximately €29 million.

The project is expected to create approximately 25 direct jobs, contributing to the development of specialized pharmaceutical and radiopharmaceutical manufacturing capabilities in the Valenciennes region.

The facility was selected under the France 2030 plan following the call for “Industrialization and health capacities 2030.” It also received almost €3.8 million in public support, reflecting the strategic importance placed on developing domestic and European healthcare manufacturing capabilities.

The investment combines pharmaceutical manufacturing requirements with Orano’s established expertise in nuclear materials and radioactive substances. According to the company, the site demonstrates how this industrial and technical expertise can be applied to the development of advanced cancer treatments.

Nicolas Maes, Chief Executive Officer of Orano, said the inauguration represents a significant industrial milestone for Orano Med and the broader Orano Group.

“The inauguration of ATLab Valenciennes marks a major industrial milestone for Orano Med and confirms the Orano group’s ability to innovate and deploy breakthrough technologies to advance healthcare,” Maes said.

“This site embodies our commitment to putting our industrial know-how and our expertise in handling nuclear materials at the service of cancer patients, in France and across Europe,” he added.

Addressing the Short Half-Life of Lead-212

The short half-life of lead-212 is both an important feature of the isotope and a significant logistical consideration for its use in radiopharmaceutical treatments.

Lead-212 has a half-life of only 10.6 hours, meaning that therapies incorporating the isotope cannot be manufactured and distributed using conventional pharmaceutical supply-chain models. The production, shipment and administration of a dose must occur within a highly compressed period.

Orano Med says its targeted alpha therapies need to be produced, shipped and administered to patients within 24 hours.

The location of ATLab Valenciennes is therefore a critical part of the manufacturing strategy. The facility is located approximately two hours from Paris-Charles de Gaulle Airport and Brussels-Zaventem Airport, providing access to major European air transportation infrastructure.

According to Orano Med, this location enables the company to deliver treatments to hospitals within the required timeframe and potentially reach approximately 70% of the European population.

The site is therefore designed not simply as a production facility, but as part of an integrated manufacturing and logistics network built around the physical properties of lead-212.

Orano Med Builds Integrated European and U.S. Capacity

The Valenciennes facility is one component of Orano Med’s broader industrial strategy.

A similar production facility is currently being commissioned in Indianapolis, United States, where it is intended to serve the North American market.

The European and U.S. ATLabs are expected to provide regional production capacity, allowing Orano Med to address the different logistical requirements associated with delivering short-lived radiopharmaceutical products to hospitals and patients.

Together, the two sites form part of what the company describes as a fully integrated industrial platform.

The approach is intended to give Orano Med greater control over critical stages of the targeted alpha therapy manufacturing process, from isotope production and raw-material access through to pharmaceutical manufacturing and distribution.

This integrated model could become increasingly important as the company advances multiple candidates through clinical development.

Securing the Supply Chain for Lead-212 Therapies

One of the principal challenges facing the radiopharmaceutical industry is access to sufficient quantities of radioactive isotopes.

For targeted alpha therapies, reliable isotope supply is particularly important because manufacturing schedules, product shelf life and clinical administration are all closely linked to radioactive decay.

Orano Med says its industrial platform is supported by a patented chemical process for lead-212 production as well as secured access to raw materials.

The combination of isotope expertise, raw-material access and dedicated pharmaceutical manufacturing is designed to address several challenges simultaneously.

These include ensuring isotope availability, establishing consistent manufacturing processes and scaling production as clinical and commercial requirements increase.

By controlling more elements of the supply chain, Orano Med aims to reduce potential constraints that could otherwise limit the ability to produce targeted alpha therapies at larger volumes.

Manufacturing Designed Around Clinical Requirements

Frederic Desdouits, Chief Executive Officer of Orano Med, said the inauguration represents a significant milestone in establishing the company’s European industrial platform.

“With the inauguration of ATLab Valenciennes, we have taken a decisive step in deploying our industrial platform in Europe,” Desdouits said.

He emphasized that the facility was designed to accommodate the logistical requirements associated with lead-212.

“The site provides large-scale production capacity designed to meet the logistical constraints resulting from the half-life of lead-212,” he added.

Desdouits also highlighted the potential role of the ATLab network in expanding access to new oncology treatments.

“In the future, the ATLab will enable us to offer European patients new therapeutic options for cancer types with high unmet medical needs,” he said.

The comments reflect the relationship between manufacturing capacity and clinical development in radiopharmaceuticals. Unlike conventional pharmaceutical products, radioactive therapies require manufacturing and distribution systems that account for radioactive decay from the moment the isotope is produced.

As a result, manufacturing infrastructure must be developed alongside clinical programs rather than after successful clinical development.

Four Clinical Programs Under Development

The inauguration of ATLab Valenciennes comes as Orano Med continues to advance its targeted alpha therapy pipeline.

The company currently has four drug candidates in clinical development in humans. These programs include proprietary candidates as well as therapies being developed in collaboration with pharmaceutical and biotechnology partners.

Orano Med is working with Sanofi, Roche and Molecular Partners on co-development programs, broadening the application of its targeted alpha therapy technology through external partnerships.

These collaborations allow Orano Med to combine its expertise in alpha-emitting radiopharmaceuticals with partners’ knowledge of drug discovery, molecular targeting and specific therapeutic areas.

The company is also advancing a broader preclinical pipeline, with the goal of extending targeted alpha therapy approaches into additional cancer types.

The development strategy is intended to establish a diversified portfolio rather than relying on a single therapeutic program. As different tumor types express different molecular targets, expanding the range of targeting molecules and biological mechanisms could potentially broaden the applicability of lead-212-based therapies.

The Growing Role of Radioligand Therapies in Oncology

Radioligand therapies have attracted increasing attention in oncology because they can combine molecular targeting with radioactive payloads.

Unlike traditional systemic chemotherapy, which can affect both healthy and cancerous cells, targeted radiopharmaceutical approaches are designed to deliver radiation more selectively to cells expressing a particular molecular target.

Alpha particles have characteristics that make them particularly interesting for cancer treatment. They can deliver high-energy radiation over a relatively short distance, potentially producing substantial biological effects in targeted tumor cells while limiting the range of radiation exposure.

However, developing these therapies requires more than demonstrating clinical activity. Manufacturing, isotope production, quality control, transportation, radiation safety and supply-chain management all need to operate together.

ATLab Valenciennes represents Orano Med’s investment in that industrial infrastructure.

Supporting Europe’s Radiopharmaceutical Manufacturing Capacity

The facility also contributes to the broader development of European manufacturing capabilities for advanced radiopharmaceuticals.

The combination of public support through France 2030 and private investment from Orano Med illustrates the strategic importance of developing specialized healthcare production infrastructure in Europe.

The facility’s location near major international airports is particularly relevant because the short half-life of lead-212 limits the geographic range over which products can be distributed efficiently.

By establishing production near major transportation hubs, Orano Med is seeking to integrate manufacturing capacity with the time-sensitive requirements of patient treatment.

The planned production capacity of up to 10,000 doses annually in the medium term provides a foundation for supporting clinical and, subject to successful development and regulatory approval, potential commercial demand.

At full capacity, the company says production potential could be increased fivefold.

The inauguration of ATLab Valenciennes represents a major infrastructure milestone for Orano Med as it advances lead-212-based targeted alpha therapies toward potential future use in oncology.

The facility combines pharmaceutical manufacturing capabilities with Orano’s expertise in nuclear materials and is specifically designed around the demanding logistics associated with lead-212’s 10.6-hour half-life.

With more than 3,000 square meters of manufacturing space, a €29 million investment, approximately 25 planned direct jobs and medium-term production capacity of up to 10,000 doses annually, the site establishes a significant European manufacturing base for Orano Med’s radiopharmaceutical programs.

Its proximity to Paris-Charles de Gaulle and Brussels-Zaventem airports is intended to support rapid delivery to hospitals, with the company estimating potential coverage of nearly 70% of the European population. The planned Indianapolis ATLab is expected to provide comparable infrastructure for North America.

Meanwhile, Orano Med continues to advance four drug candidates in human clinical development, including proprietary and partnered programs involving Sanofi, Roche and Molecular Partners, while expanding its preclinical pipeline into additional cancer types.

The development of ATLab Valenciennes therefore represents more than the opening of a new manufacturing facility. It is a component of Orano Med’s broader effort to establish an integrated platform spanning isotope supply, radiopharmaceutical production, logistics and clinical development.

As targeted alpha therapies continue to progress through clinical testing, the ability to manufacture and deliver these short-lived treatments reliably will remain a critical factor in their potential adoption. ATLab Valenciennes is designed to address that challenge by creating dedicated industrial-scale capacity close to major European transportation infrastructure and positioning Orano Med to support the next stages of its lead-212 oncology pipeline.

About Orano

As a recognized international operator in the field of nuclear materials, Orano delivers solutions to address present and future global energy and health challenges. Its expertise and mastery of cutting-edge technologies enable Orano to offer its customers high value-added products and services throughout the entire fuel cycle. Every day, the Orano group’s 18,500 employees draw on their skills, unwavering dedication to safety and constant quest for innovation, with the commitment to develop know-how in the transformation and control of nuclear materials, for the climate and for a healthy and resource-efficient world, now and tomorrow.

Orano, giving nuclear energy its full value.

About Orano Med

Orano Med is a subsidiary of the Orano group. Orano Med is a clinical-stage biotechnology company that develops a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), an alpha-emitting radioisotope and one of the most potent therapeutic payloads against cancer cells known as Targeted Alpha Therapy (TAT). Leveraging its unique and secured access to 212Pb, the company is developing several 212Pb-based radioligand therapies combined with various targeting agents. Orano Med has 212Pb manufacturing facilities, laboratories, and R&D centers in France and in the US and is currently expanding its GMP-manufacturing capacities for 212Pb radiolabeled pharmaceuticals in North America and Europe.

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