ATLab Indianapolis represents significant initial step in the company's strategy to address challenges of the radiopharmaceutical sector in terms of production and supply of radioligand therapies.
Regulatory News:
Orano Med (a subsidiary of the Orano Group), a pioneer in the development of targeted alpha therapies for oncology, today inaugurated its first ATLab (Alpha Therapy Laboratory), located in Brownsburg near Indianapolis, Indiana, in the United States. ATLab Indianapolis is the world's first industrial-scale pharmaceutical facility dedicated to the production of lead-212-based radioligand therapies.
The inauguration ceremony was attended by Yannick Tagand, Consul General of France in Chicago, Tony Denhart, Executive Vice President for Talent and Workforce of the Indiana Economic Development Corporation (IEDC), Travis Tschaenn, President of the Brownsburg Town Council, Guillaume Dureau, Senior Executive Vice-President Projects Innovation R&D and Nuclear Medicine for the Orano Group, Jean-Luc Palayer, President and CEO of Orano USA, and Julien Dodet, President and CEO of Orano Med.
Guillaume Dureau commented: "The ATLab in Indianapolis is a very important step in the development of the Orano medical activities in the U.S. Coupled with the lead-212 production capacity of our research unit in Plano, Texas the Domestic Distribution Purification Unit this new industrial site will enable us to serve North American patients requiring targeted lead-212 radiotherapy treatments."
Targeted Alpha Therapy with lead-212 combines the natural ability of biological molecules to target cancer cells with the short-range cell-killing capabilities of lead-212 generated alpha emissions. The development of radiopharmaceuticals has long been hampered by the difficulty of manufacturing and distributing on an industrial scale. The construction of Orano Med's ATLab Indianapolis is therefore a major step towards making these promising new treatments available to cancer patients with high unmet needs in North America.
ATLab Indianapolis, with over 30,000 ft² (2,800 m²) of floor space, represents an investment of $20 million and will create 25 direct jobs. It will focus on the production of lead-212 therapies developed by Orano Med and their distribution in North America. In 2023, Orano Med started construction work on a similar facility at Valenciennes in France to serve the European market.
Combined, this will enable Orano Med to manufacture 10,000 doses a year worldwide as of 2025, with the aim of producing ten times that number by the end of the decade. The location near Indianapolis was chosen for its proximity to major national and international distribution networks, with the second largest FedEx hub ensuring reliable transport of radiopharmaceutical products, and its high concentration of pharmaceutical companies and skilled workforce. The construction of further ATLabs is therefore envisaged to meet patients' needs worldwide.
Julien Dodet, CEO of Orano Med: "We are convinced that lead-212 radioligand therapies will soon become an essential tool in the fight against cancer. Having obtained, together with our partner RadioMedix, Breakthrough Therapy Designation (BTD) from the FDA for our most advanced drug AlphaMedix, the inauguration of ATLab Indianapolis represents another major step forward in the development, production, and distribution of these new treatments on a large scale."
About Orano
As a recognized international leading 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 17,500 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, a subsidiary of the Orano Group, is a clinical-stage biotechnology company developing a new generation of targeted therapies against cancer using the unique properties of lead-212 (212Pb), a rare alpha-emitting radioisotope and one of the most potent therapeutic payloads against cancer cells. This technology is known as targeted alpha therapy (TAT). The company is developing a portfolio of treatments combining 212Pb with a range of targeting vectors. Orano Med has 212Pb production facilities, laboratories and R&D centers in France and the United States.
More information on www.oranomed.com
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