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PR IBA ICNA Market authorization Ga68

ICNAS/University of Coimbra granted with first EU marketing authorization for the distribution of cyclotron produced Gallium-68

ICNAS/University of Coimbra granted with first EU marketing authorization for the distribution of cyclotron produced Gallium-68 The Institute of Nuclear Sciences Applied to Health (ICNAS) from the University of Coimbra (UC) and IBA announce the granting of the first EU marketing authorization for the distribution of cyclotron-produced Gallium-68 using a liquid target for human use Coimbra, Portugal, 28 September 2021 – ICNAS/UC, leading institution in molecular probe development and molecular imaging and IBA (Ion Beam Applications S.A., EURONEXT), the world's leading provider of solutions for the diagnosis and treatment of cancer, today announce that the Portuguese regulatory agency (INFARMED), has granted the first EU marketing authorization to distribute [68Ga]GaCl3 with a new process for producing gallium-68 with an IBA cyclotron using a liquid target. 68Ga has played an outstanding role in clinical research worldwide, particularly in routine clinical studies for oncological applications with Positron Emission Tomography (PET), during the last 10 years. In particular, 68Ga is very well suited as a diagnostic isotope for pairing with therapeutic radiometal isotopes (ex: 177Lu and 225Ac). The growth of 68Ga in routine clinical applications is mainly due to the [68Ga]Ga-PSMA-11 for PET imaging of the prostate specific membrane antigen (PSMA). The imaging of PSMA expression with [68Ga]Ga-PSMA-11 and PET/CT has proven to be a highly  specific and sensitive tool for patient management. “This optimized new production process is the result of the strong collaboration between IBA and ICNAS” said Bruno Scutnaire, Vice-President of IBA's RadioPharma Solutions Division. This FGD-like production process is easy to implement and allows cyclotron production centers to maximize the use of their equipment. The process consists of the irradiation of an enriched 68Zn solution in a 68Ga liquid target installed on a Cyclone® KIUBE. The target solution is then transferred to a Synthera® extension module which purifies the irradiated solution to obtain [68Ga]GaCl3, which is equivalent to [68Ga]GaCl3 from the commercial 68Ge/68Ga generators. “Currently, the availability and efficiency of 68Ge/68Ga generators is not enough to meet global demand and they have limited elution capacity per day and decay over time, while the 68Ga-cyclotron process allows stable, on-demand production throughout the whole year” commented Antero Abrunhosa, Director at ICNAS. “We can see a clear benefit to producing 68Ga with a cyclotron using a liquid target; the production is consistent and allows a higher production volume. This new patented process provides a viable alternative for facilities with cyclotrons securing 68Ga access locally and for distribution.”
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IBA and SCK CEN join forces to enable production of Actinium-225

Collaboration marks first step in evaluating  the potential of the rapidly growing theranostics market Louvain-La-Neuve, Belgium, 15 September 2021 – IBA (Ion Beam Applications S.A., EURONEXT), the world leader in particle accelerator technology, and SCK CEN (Belgian Nuclear Research Center) today announce a strategic R&D partnership to enable the production of Actinimum-225 (225Ac), a novel radioisotope which has significant potential in the treatment of cancer.   New perspectives in the treatment of cancer Nuclear medicine has evolved considerably over recent years with the emergence of radiotheranostics, a modality which combines targeted diagnosis and therapy with radio-isotopes, offering an important alternative in the treatment of many cancers. Radiotheranostics is based on the use of radio-isotopes which, when they disintegrate, emit radiation that enables cancer cells to be precisely located and/or destroyed.   Actinium-225: fighting both prevalent and rare cancers Among these isotopes, one of the most promising is alpha-emitting Actinium-225. This is due to its useful characteristics: in its decay, it kills cancer cells, having high cytotoxic potency within a very short range (limited to few cancerous cells while sparing surrounding healthy tissues). Moreover its half-life (10 days) enables a smooth process for logistics and centralized distribution. To date, extensive research and numerous studies are underway which aim to tackle both high prevalence cancers including prostate, lung, colon, breast, pancreatic, blood (leukemia and other rare forms) and kidney cancers, but also rarer forms of cancer like glioblastoma, the deadliest form of a very invasive brain cancer.   One of the main challenges to making this therapeutic solution accessible for the greatest number of patients is ensuring the availability of high-quality Actinium-225 in large quantities. By joining their unique expertise and resources, SCK CEN and IBA will be able to work towards the large-scale production of Actinium-225 for patient use. Concurrently, this collaboration will allow them to establish themselves as leading global partners in the production of Actinium-225.   A new generation of nuclear medicine This strategic R&D partnership consists of an in-depth evaluation of the technical and economic feasibility of the project. Based on the outcome of this first phase, SCK CEN and IBA plan to undertake the construction and commissioning of a production unit on the SCK CEN site in Mol, Belgium.   Alignment with Belgian coalition agreement and European recovery plan This collaboration highlights the implementation of the Belgian coalition agreement, which pledges significantly more and better cancer treatments and confirms Belgium’s leadership at the forefront of nuclear medicine. It is supported by Pierre-Yves Dermagne, Belgian Deputy Prime Minister and Minister of Economy and Employment, Tinne Van der Straeten, Belgian Minister of Energy, and Thomas Dermine, Belgian State Secretary for Recovery and Strategic Investments.   This initiative is also in alignment with the recent European recovery plan for Belgium – a plan in which the European Commission designated Lutetium-177 and Actinium-225 as promising isotopes.   “We are excited to join forces with such a prestigious and highly experienced partner as SCK CEN” said Olivier Legrain, CEO of IBA. “Considering our global leadership and long-standing expertise in nuclear medicine and proton therapy, we see theranostics as an important addition to our portfolio of activities in the fight against cancer. We look forward to taking the first steps in evaluating the strategic growth potential in this significant new market.”   Eric van Walle, Director General of SCK CEN, commented: “Theranostics have the potential to revolutionize the way we treat cancer. By partnering with IBA, we can use our nuclear knowhow to transform isotopes meant to become radioactive waste into therapeutic compounds. Our complementary expertise will enable us to work towards providing the greatest number of patients with the benefits of this latest generation of nuclear medicine.”   "I am particularly pleased with this unprecedented partnership between two key players with unparalleled expertise," said Pierre-Yves Dermagne, Vice Prime Minister. "This research partnership has promise for the future. One of the two players is recognized worldwide (SCK CEN, a federal research center), while the other is a worldwide leader in the particle accelerator industry (IBA). This union will make it possible to treat patients much more effectively," notes Pierre-Yves Dermagne.   Tinne Van der Straeten, Minister of Energy, stresses the importance of this project and the expertise of both partners."Belgium wants to remain a world leader in the production of medical isotopes. Therefore, we have provided support in the framework of the European recovery plan to allow SCK CEN to innovate in the field of therapeutic radiopharmaceuticals. SCK CEN and IBA are combining their extensive expertise into this R&D partnership to collaborate on isotopes that can be used in more targeted cancer treatments. I am delighted to support these developments in Belgium and watch them grow.”   “This strategic R&D partnership is one of the first concrete results of the recovery plan, which allocates a total of more than EUR 800 million additional resources to research and development," explains Thomas Dermine, State Secretary for Recovery and Strategic Investments. "Together, SCK CEN and IBA are stepping up the fight against cancer. This is an excellent example of how our country can play a key role in the development of future technologies and techniques worldwide. The medical application of radioisotopes is an area of global excellence for Belgium that the recovery plan aims to consolidate.”
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Опираясь на 35-летний опыт, IBA RadioPharma Solutions помогает центрам ядерной медицины проектировать, строить и эксплуатировать отделения ПЭТ для производства радиофармпрепаратов, используемых для диагностики и лечения рака и других критических заболеваний.

IBA будут работать с вами и поддерживать в течение всего процесса — на первой встрече, при проектировании, монтаже и введении в эксплуатацию. Более того, эксперты IBA будут сопровождать вас на протяжении всего срока службы радиофармацевтического оборудования: проводить обучение, выполнять необходимые обновления и техническое обслуживание, чтобы обеспечить успех вашего проекта в соответствии с принципами устойчивого развития.

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