IRE ELiT and ROTOP Pharmaka enter into a distribution partnership in Germany for 68Germanium / 68Gallium generator

IRE ELiT and ROTOP Pharmaka, two innovative radiopharmaceuticals companies focused on diagnostics and therapeutics announce today they have entered into an exclusive commercial agreement for the distribution of Galli Ad (the 68Ge/68Ga generator from IRE ELiT) in Germany.

This strategic decision is an important step to increase the presence of Galli Ad generators in Germany, representing the leading market in Europe for Gallium-68 development.

The switch over from distributorship will be effective early 2021, with total continuity of supply and support to our current customers. The practical modalities will be communicated to them soon.

Erich Kollegger CEO of IRE ELiT stated “We believe that there is a real and mutual interest for IRE ELiT and ROTOP to partner. The combination of our expertise and the reputation of ROTOP will work for the benefit of the patients and nuclear medicine professionals. This partnership will strengthen our position on the European market and contribute to the global development of this essential radiopharmaceutical.”

Jens Junker Managing Partner at ROTOP Pharmaka stated “We are proud to enter into the partnership with IRE ELit, one of the leading European radiopharmaceutical companies, which is driving innovation for the benefit of patients and nuclear medicine. With the Galli Ad generators ROTOP enhances its portfolio of radiopharmaceuticals in Germany and continues the strategy of offering a wide range of radiopharmaceuticals.”  

 

 

About Galli Ad ® generator                                            

Galli Ad is a 68Germanium/68Gallium generator, approved in Europe for the in vitro radiolabeling of specific vector molecules that have been specifically developed and authorized for radiolabeling with this radionuclide for positron emission tomography (PET) diagnostic imaging.

The innovation of the Galli Ad generator is having been specifically designed, due to its technical properties, to be combined with cold kits in order to get closer to the best practice in nuclear medicine using Technetium-99m generators (another diagnostic radionuclide used very easily with cold kits for SPECT imaging).

This innovation is based on three unique aspects:

  1. An innovative elution mechanism delivering a very small and always fixed amount of eluate: 1.1 ml of a Gallium (68Ga) chloride solution for radiolabelling
  2. A unique chromatographic column: dry, on which the 68Germanium(68Ge) is adsorbed.
  3. A ready-to-use system integrating the eluent pouch which is pre-connected to the inside of the generator.

These characteristics simplify and reduce the steps for the preparation of radiopharmaceuticals; ensure their reproducibility and contribute to operator safety;

For further information on 68Germanium/68Gallium generator please consult the SmPC (Summary of Product Characteristics) of the product available on our website www.ire.eu

About ROTOP Pharmaka

ROTOP Pharmaka is a leading German pharmaceutical company that produces cGMP compliant radiopharmaceuticals for diagnostics and therapy in Nuclear Medicine and Molecular Imaging and distributes them in more than 30 countries worldwide. With more than 20 years of experience in the development, production, authorization and distribution of sterile kits for radiolabeled pharmaceuticals ROTOP continuously expands its product portfolio by developing new products and entering new strategic partnerships. The portfolio includes a GMP Kit production facility, the ROTOP Innovation Center (RIC) with full CRO Services, incl. API and Kit development, the ROTOP Radiopharmacy with I-123 compounds and a worldwide distribution network. More information on www.rotop-pharmaka.de

Bérénice Pignol

IRE - IRE ELiT

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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