Orano Med Inaugurates World’s First Industrial-Scale Lead-212 Radiopharmaceuticals Manufacturing Facility
June 06 2024 - 3:22PM
Business Wire
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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