First Elucirem™ (Gadopiclenol) injection administered to European patients for an MRI scan.

• Elucirem™ (Gadopiclenol), a macrocyclic gadolinium-based contrast agent, was injected for the first time in Germany in early April 2024.
• Elucirem™ ensures satisfactory image quality with its high relaxivity, requiring only half the gadolinium dose compared to other non-specific contrast agents on the market, thereby addressing the concerns expressed by practitioners regarding exposure to gadolinium.
• Invented*, designed and manufactured by Guerbet, Elucirem™ received a market authorisation (MA) from the European Commission on 11 December 2023, in wake of its approval from the FDA in the United States in September 2022.
• It is produced in the Guerbet plants in France for Europe and in the United States for the US market.

Villepinte, France, 18 April 2024 

Guerbet continues to stand out as a leading player in the area of gadolinium-based contrast agents (GBCAs) with its innovative and groundbreaking product Elucirem™ that has now been injected for the first time in European patients undergoing an MRI scan.

 

Elucirem™ , optimised efficacy at half the dose of gadolinium¹

Elucirem™ (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent offering high relaxivity and high kinetic stability. Elucirem™ is indicated in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging (MRI) to improve detection and visualization of pathologies with disruption of the blood-brain-barrier (BBB) and/or abnormal vascularity of:

• the brain, spine, and associated tissues of the central nervous system (CNS);
• the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system.

 

Gadolinium-based contrast agents (GBCAs) are essential in magnetic resonance imaging (MRI) to assess malignant or benign diseases. The PICTURE¹ and PROMISE² clinical studies have shown that Elucirem™, thanks to its high relaxivity, offers non-inferior diagnostic efficacy at half the dose of gadobutrol, a GBCA commonly used in clinical practice throughout the EU.

For Professor Bernd Hamm, Director of the Department of Radiology and Paediatric Radiology at Charité Berlin university hospital:

“Contrast agents are important tools to deliver improved diagnostic imaging results. With Elucirem™, we now have a product that offers significant added value for patients and for the environment thanks to the lower dose of gadolinium injected. It is particularly indicated for patients requiring multiple administrations of contrast agent (e.g. with follow-up exams) in order to reduce the amount of gadolinium injected.”

 

* Relaxivity is a key component of the efficacy of a contrast agent.

Elucirem™ (Gadopiclenol), efficacy and safety for patients

The efficacy and safety of Elucirem™ (Gadopiclenol) have been evaluated as part of Guerbet’s clinical development plan with a view to obtaining marketing authorisations worldwide. The significant benefits of Elucirem™ (Gadopiclenol) in terms of efficacy and safety were reported¹ in two Phase III clinical studies, i.e. PICTURE¹ (published in Investigative Radiology in 2023) and PROMISE² (published in Radiology in 2023).

Produced in Europe at Guerbet's industrial sites at Lanester, Marans and Aulnay-sous-Bois, which employ around 600 staff, Elucirem™ (Gadopiclenol) expands Guerbet's range of contrast agents and strengthens its position as market leader. This illustrates Guerbet’s strategic goal to develop and manufacture in Europe.


For David Hale, the Chief Executive Officer of Guerbet: “Several thousands of patients have already benefited from imaging with Elucirem™ in the United States. Production is now underway at our French sites, and we have started to market the product in Europe, with a strong growth in demand. Our strategy is to support our radiology customers to discover this new product and learn how to use it, as it offers proven benefits for both patients and the environment.”


“The initial feedback from radiologists confirms our view of the role of Elucirem™ . Its use is particularly recommended in patients requiring multiple MRI examinations with contrast agents and in sensitive patients, including paediatric patients and patients with impaired kidney function”, concluded Philippe Bourrinet, Senior Vice President Development, Medical & Regulatory Affairs and Group Responsible Pharmacist, Guerbet.

 

About Guerbet

At Guerbet, we build lasting relationships to enable people to live better lives. This is our Company Purpose (or Raison d’Être in French). We are a global leader in medical imaging, proposing a wide range of pharmaceutical products, medical devices, digital and AI solutions for diagnostic and interventional imaging. A pioneer for 95 years in the field of contrast products, with more than 2,600 employees worldwide, we continuously provide innovative solutions and devote 10% of our sales to Research & Development in four centres in France, Israel and the USA. Guerbet (GBT) is listed in compartment B of Euronext Paris and our turnover was 753 million euros in 2022. For more information, please visit www.guerbet.com.

Forward-looking statements

This press release may contain statements of a forward-looking nature, based on assumptions and predictions made by the management of the Guerbet group. Various known and unknown risks, uncertainties and other factors could lead to marked differences between the future results, financial situation, development and performances of the company, and the estimates made here. These factors include those mentioned in the public reports of Guerbet, available on its website www.guerbet.com.The company assumes no responsibility whatsoever in relation to the updating of these forward-looking statements, or how they correspond to future events or developments.

 

¹ Loevner LA et al. Efficacy and safety of gadopiclenol for contrast-enhanced MRI of the central nervous system- The PICTURE randomized clinical trial. Invest Radiol 2023;58(5):307-313
² Kuhl C et al. Efficacy and safety of half-dose gadopiclenol versus full-dose gadobutrol for contrast-enhanced body MRI. Radiology 2023;308(1):e222612
³ Bashir MR and Thomas KL, A new generation of gadolinium-based MRI contrast agents: higher relaxivity, lower dose. Radiology 2023;308(1):e231454
*Information on patent rights. Current status and listing of granted patents and published patent applications concerning Elucirem™ may be found online with the Espacenet database and/or with the European Patent Register at https://worldwide.espacenet.com or at https://register.epo.org under the applicant name: Guerbet.

*Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco intellectual property, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity  

 

 

 

Contacts :
Guerbet
Christine Allard, Group Communication Director 33.6.30.11.57.82 / [email protected]
LauMa Communication
Mathilde Birembaux, Media Relations 33.6.82.34.25.38 / [email protected]
Laurent Mignon, Director, 33.6.10.17.54.84 / [email protected]