Cancer imaging: The submitted file of IRE ELiT’s 68Ge/68Ga generator has been accepted in 13 European countries

  • The young Belgian biotechnology company IRE ELiT, a subsidiary of IRE (Institute for Radioelements), has just taken a key step towards the conquest of the radiopharmaceuticals market.

  • IRE ELiT’s radiopharmaceutical new generation, Ge-68/Ga-68 generator, developed entirely in Fleurus (Belgium), has been accepted by RMS [1]  and all CMS [2] of 13 European countries. The commercialization will be allowed for the first of these 13 countries within the next one to two months.

  • This generator opens up significant possibilities in the diagnosis of neuroendocrine cancers and of recurrent forms of prostate cancer.

On May 9th, IRE ELiT, a subsidiary and innovation hub of IRE (Institute for Radioelements), received the acceptance of RMS and all CMS for its radiopharmaceutical Germanium-68/Gallium-68 generator which represents a major breakthrough in the world of nuclear medicine and medical imaging.

Gallium-68 is the isotope which, when accompanied by a cold vector, is used in oncology for the diagnosis of neuroendocrine cancers, particularly difficult to detect at the early stage. It is also used in clinical development of highly specific diagnostic agents such as for the diagnosis of prostate cancer (recurrent forms), the most common cancer in men.

Nuclear medicine uses the properties of the radiation emitted by a radioactive isotope for diagnostic and therapeutic purposes. In oncology, radiopharmaceutical diagnoses can determine the number and aggressiveness of tumours and metastases. Today, radiopharmaceutical diagnosis accompanied by their therapeutic counterpart open a new era in the field of personalised medicine (theranostic: “the right treatment for the right patient”).

Five years of research and development

Five years ago, IRE ELiT launched the project to develop a next generation generator. There were four generators on the market at the time, and users’ expectations were not being fully met, in particular in terms of ease of use.

After five years of research and development, IRE ELiT developed a generator that responds to these demands, with due regard for operator safety and for the cost to the hospital.

Erich Kollegger, CEO of IRE and IRE ELiT: “Our Germanium-68/Gallium-68 generator enables simplified and reliable usage while optimising costs for hospitals. Our goal is to offer innovative solutions to meet patients’ needs regarding cancer diagnosis and treatment.”

Michel Baijot, Board Director IRE ELiT: “We are proud to be able to offer to the market our Germanium-68/Gallium-68 generator, the result of our research, entirely developed and produced in Fleurus. This radiopharmaceutical product is destined for a great future. This acceptance will accelerate the growth of IRE ELiT on the main markets, based on partnerships for sales and marketing activities, such as the one already in place with Cardinal Health in the USA or those in place on the European markets. The goal is to have as wide access as possible for the benefit of patients.”

[1] RMS = Reference Member State
​[2] CMS = Concerned Member States

Technical information sheet

PDF 498 KB
Download

Philippe Van Put

Head of Business Development , IRE ELiT

Martine Maelschalck

Whyte Corporate Affairs

Get updates in your mailbox

By clicking "Subscribe" I confirm I have read and agree to the Privacy Policy.

About IRE and IRE ELiT

Founded in 1971 and based in Fleurus, in the province of Hainaut, the National Institute of Radioelements (IRE), a Belgian foundation of public interest, is one of the very few players worldwide capable of producing and developing certain radioisotopes used in nuclear medicine.

IRE is notably the global leader in the production of Molybdenum‑99, the “parent” isotope of metastable Technetium-99m. Using a gamma camera, this isotope makes it possible to observe a patient’s internal anatomy in real time (heart, bones, lungs, thyroid, brain, kidneys, etc.) and to diagnose certain diseases at an early stage. IRE supplies around 50% of European demand for Mo-99 and 25% of global production, a share that can rise to up to 65% during periods of global supply tension.

At the same time, IRE ELiT, a subsidiary founded in 2010, is one of the two global leaders in pharmaceutical‑grade Ge-68/Ga-68 generators for human use. Gallium-68 (Ga-68) is a key isotope for high‑precision PET imaging - particularly for neuroendocrine tumours and prostate cancer - and for personalised medicine in radioligand therapy (RLT) strategies. IRE-ELiT’s Ga-68 generators are currently marketed in around 40 countries.

Beyond its production activities aimed at improving patient care and quality of life, IRE also contributes - through its IRE Lab division - to environmental protection and monitoring. The Institute offers services for radioactivity measurement in various samples, radiological characterisation of waste and contaminated materials, as well as consultancy and technical support in the radiological and nuclear fields.

Today, IRE and IRE ELiT employ 300 people, all committed to translating cutting‑edge scientific advances into diagnostic and therapeutic solutions for patients.

More information: www.ire.eu

Contact

www.ire.eu