Elucirem (Gadopiclenol) is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity indicated for use in adults and children aged 2 years and older for contrast-enhanced magnetic resonance imaging. The product was approved in 2022 by FDA to be used to detect and visualize lesions with abnormal vascularity in the central nervous system (brain, spine and associated tissues) and the body (head and neck, thorax, abdomen, pelvis, and musculoskeletal system). However, given its at least twofold higher relaxivity than other GBCAs, the performance of Elucirem in cardiac MR (CMR) has yet to be demonstrated.
The hypothesis for the study: Half dose (0.05mmol/kg) Elucirem is not inferior to double dose (0.2 mmol/kg) Dotarem in the myocardial scar assessment.
All participants will be selected from the investigators previous CMR study cohort with double-dose Dotarem T1 mapping and LGE images. Ten participants without scars will be recruited for the Phase I dose evaluation. Five for 0.05 mmol/kg and five for 0.075 mmol/kg. The investigators have identified 15 participants with LGE findings from double-dose Dotarem CMR acquired in the years 2021, 2022, or earlier years. This study was performed in August 2022. The same protocol will be used for single-dose Elucirem.

Start Date15 Feb 2025

Sponsor / Collaborator

The Johns Hopkins University

[+1]

NCT06127810 / Not yet recruitingNot ApplicableIIT

A Pilot Study of Gadopiclenol for Imaging Central Nervous System (CNS) Tumors At Point of Care Magnetic Resonance Imaging (MRI)

The purpose of this pilot study is to compare a standard of care MRI scan to a non-standard of care MR imaging with portable (0.064 Tesla) MRI following the administration of non-SOC contrast called Gadopiclenol on 10 subjects with known brain tumors.
Participants will be randomized to receive either standard MRI or portable MRI first following contrast injection

Start Date01 Jan 2025

Sponsor / Collaborator

Medical University of South Carolina

[+1]

NCT06596616 / RecruitingNot ApplicableIIT

MR Image Quality and Liver Lesion Detection With Gadopiclenol: Comparison With Gadoxetate Disodium

The overall purpose of this study is to establish noninferiority of gadopiclenol MRI compared to gadoxetate MRI in terms of image quality and lesion detection/conspicuity in patients undergoing clinically indicated liver MRI in a prospective study. The research will be utilizing MRI; with enrollment goal of 75 subjects over the course of two years.

Start Date01 Jul 2024

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+1]

100 Clinical Results associated with Gadopiclenol

100 Translational Medicine associated with Gadopiclenol

100 Patents (Medical) associated with Gadopiclenol

Literatures (Medical) associated with Gadopiclenol

01 Sep 2024·INVESTIGATIVE RADIOLOGY

Evaluation of the Contrast Enhancement Performance of Gadopiclenol for Magnetic Resonance Angiography in Healthy Rabbits and Pigs

Article

Author: Robert, Philippe ; Wintrebert, Mélody ; Arnould, Laurent ; Serfaty, Jean-Michel ; Adriaensen, Hans ; Hugon, Gaëlle

Objectives:

Unexpected accumulations of gadolinium in various organs were reported after the administration of gadolinium-based contrast agents, making desirable to reduce the dose while maintaining equivalent diagnostic performance. The aim of this study was to evaluate the contrast enhancement performance of high relaxivity gadopiclenol compared with gadoterate meglumine in abdominal contrast-enhanced magnetic resonance angiography (CE-MRA).

Materials and Methods:

In a first study in healthy rabbits, axial 3D gradient echo sequences were applied at 4.7 T to study arterial enhancement as a function of gadopiclenol dose (0.025, 0.05, 0.075, and 0.1 mmol Gd/kg) or gadoterate meglumine at 0.1 mmol Gd/kg (n = 5–6/group). The increase in signal-to-noise ratio (ΔSNR) in the aorta at the first pass was measured and compared. In a second, crossover study in 6 healthy pigs, abdominal CE-MRA sequences were acquired at 3 T with gadopiclenol at 0.05 mmol Gd/kg or gadoterate meglumine at 0.1 mmol Gd/kg at a 1-week interval. Quantitatively on the maximum intensity projection (MIP) images, the mean MIP SNR within the aorta of both groups was compared. Qualitatively, a blinded comparison of the angiograms was performed by an experienced radiologist to determine the preferred contrast agent.

Results:

In the rabbit, ∆SNR is linearly correlated with the gadopiclenol dose (P= 0.0010). Compared with gadoterate meglumine 0.1 mmol Gd/kg, an increase in the ∆SNR is observed after 0.05, 0.075, and 0.1 mmol Gd/kg of gadopiclenol (+63%P= 0.0731, +78%P= 0.0081, and +72%P= 0.0773, respectively), whereas at 0.025 mmol Gd/kg, ∆SNR is in the same range as with gadoterate meglumine 0.1 mmol Gd/kg (+15%P> 0.9999). In pigs, contrast enhancement after gadopiclenol at 0.05 mmol/kg is +22% superior to MIP SNR after gadoterate meglumine at 0.1 mmol Gd/kg (P= 0.3095). Qualitatively, a preference was shown for gadopiclenol images (3/6) over the gadoterate meglumine examinations (1/6), with no preference being shown for the remainder (2/6).

Conclusions:

First-pass CE-MRA is feasible with gadopiclenol at 0.05 mmol Gd/kg with at least the same arterial signal enhancement and image quality as gadoterate meglumine at 0.1 mmol Gd/kg.

06 May 2024·Inorganic chemistry

Chiral Pyclen-Based Heptadentate Chelates as Highly Stable MRI Contrast Agents

Article

Author: Yan, Zhihan ; Dai, Lixiong ; Platas-Iglesias, Carlos ; Ding, Yinghui ; Zhu, Jiang ; Shu, Kun ; Zhang, Zhichao ; Xu, Weiyuan ; Ye, Fangfu ; Jian, Yong ; Mo, Gengshen ; Carniato, Fabio ; Xu, Jiao ; Botta, Mauro ; Gao, Ruonan ; Liu, Yao

In recent years, pyclen-based complexes have attracted a great deal of interest as magnetic resonance imaging (MRI) contrast agents (CAs) and luminescent materials, as well as radiopharmaceuticals. Remarkably, gadopiclenol, a Gd(III) bishydrated complex featuring a pyclen-based heptadentate ligand, received approval as a novel contrast agent for clinical MRI application in 2022. To maximize stability and efficiency, two novel chiral pyclen-based chelators and their complexes were developed in this study. Gd-X-PCTA-2 showed significant enhancements in both thermodynamic and kinetic stabilities compared to those of the achiral parent derivative Gd-PCTA. ¹H NMRD profiles reveal that both chiral gadolinium complexes (Gd-X-PCTA-1 and Gd-X-PCTA-2) have a higher relaxivity than Gd-PCTA, while variable-temperature ¹⁷O NMR studies show that the two inner-sphere water molecules have distinct residence times τ_M^a and τ_M^b. Furthermore, in vivo imaging demonstrates that Gd-X-PCTA-2 enhances the signal in the heart and kidneys of the mice, and the chiral Gd complexes exhibit the ability to distinguish between tumors and normal tissues in a 4T1 mouse model more efficiently than that of the clinical agent gadobutrol. Biodistribution studies show that Gd-PCTA and Gd-X-PCTA-2 are primarily cleared by a renal pathway, with 24 h residues of Gd-X-PCTA-2 in the liver and kidney being lower than those of Gd-PCTA.

01 Feb 2024·Investigative radiology

Detection of Brain Metastases by Contrast-Enhanced MRI: Comparison of Gadopiclenol and Gadobenate in a Mouse Model

Article

Author: Dencausse, Anne ; Catoen, Sarah ; Vives, Veronique ; Lemaitre, Marjorie ; Robert, Philippe ; Hao, Jing ; Soares, Miguel ; Rasschaert, Marlene

Objectives:

The aim of this study was to evaluate the capacity of gadopiclenol, a high-relaxivity gadolinium-based contrast agent to detect brain metastases in mice as a function of dose (0.08 mmol/kg or 0.1 mmol/kg) compared with gadobenate at 0.1 mmol/kg.

Materials and Methods:

Brain metastases were induced by ultrasound-guided intracardiac implantation of 1.105MDA-MB-231Br cells in the left ventricle of 18 anesthetized Balb/c Nude nu/nu female mice. At day 28 ± 3 after cell injection, each mouse received 2 crossover intravenous injections at 24-hour intervals, randomly selected from 2 doses of gadopiclenol (0.08 mmol/kg or 0.1 mmol/kg) and gadobenate (0.1 mmol/kg) with n = 6 mice/group (3 groups). Brain magnetic resonance imaging sessions were performed at 4 weeks on a 2.35 T magnet with a 3-dimensional T1-weighted high-resolution gradient echo sequence, before and after each injection. Images were blindly and randomly analyzed to detect enhancing lesions. Contrast-to-noise ratio between the metastases and the surrounding healthy parenchyma was calculated, based on region-of-interest signal measurements. In 2 animals per group, an early time point was added to the protocol (day 22 ± 3) to evaluate the sensitivity of detection as a function of time. After the last imaging session, the presence and location of whole-brain metastases were confirmed by histology in 4 mice.

Results:

After gadopiclenol, approximately twice as many metastases were detected compared with gadobenate, regardless of the dose. Contrast-to-noise ratios of the detected metastases were 2.3 and 3.3 times higher with gadopiclenol at 0.08 mmol/kg and 0.1 mmol/kg, respectively, compared with gadobenate at 0.1 mmol/kg (P< 0.0001). Gadopiclenol at the dose of 0.1 mmol/kg resulted in a 1.4-fold higher contrast compared with gadopiclenol at 0.08 mmol/kg (P< 0.02). In a subset of mice that were imaged 1 week earlier, 2 metastases were detected with gadopiclenol and not with gadobenate.

Conclusions:

The high-relaxivity macrocyclic gadolinium-based contrast agent gadopiclenol allowed higher diagnostic performance for detecting brain enhancing metastases in terms of contrast-to-noise ratio and number of detected metastases compared with gadobenate, at both equal (0.1 mmol/kg) dose and 20% lower Gd dose (0.08 mmol/kg). Tumor detection was higher after gadopiclenol at the dose of 0.1 mmol/kg compared with 0.08 mmol/kg.

News (Medical) associated with Gadopiclenol

25 Jul 2024

·www.globenewswire.com

GUERBET : H1 2024 revenue.

H1 2024 revenue Half-yearly activity H1 revenue: €419.2m, up 11.8% at CER1, including an acceleration in Q2 (+14.5%)This acceleration was driven by continued catch-up in the Americas, the normalisation of orders in France and MRI sales Annual targets confirmed Revenue: expected growth of over 8% like-for-like and at CERProfitability: restated EBITDA margin rate2 higher than in 2021 (14.4%) Villepinte, 25 July 2024, 5.45 pm: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for first-half 2024. As of June 30th, 2024, the Group’s sales totalled €419.2m, up 10.7% compared with the same period in 2023 (€378.6m). Earnings reflected a negative forex effect of €4.1m. At constant exchange rates (CER1), Guerbet’s growth over the first six months was 11.8%. This trend includes an acceleration in the second quarter (+14.5% at CER), following what was already a highly positive momentum in the first quarter (+8.8%). Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 30 June 2024H1 2023*H1 2024% changeH1 2024At CER1% changeSales in EMEA178.5183.4+2.7%182.8+2.4%Sales in the Americas98.6127.3+29.2%127.2+29.1%Sales in Asia101.5108.5+6.8%113.2+11.5%Total378.6419.2+10.7%423.3+11.8% In the EMEA region, Group revenue amounted to €183.4m in the first half, up 2.4% at CER. The decline in the first quarter (-6.2% at CER) was fully offset in the second (+11.0% at CER) as business returned to normal in France after the disruptions linked to the March 1st 2024 reform of the supply circuit for contrast products. Guerbet revenue in the Americas caught up strongly for the third consecutive quarter, with growth of 37.4% in the second quarter at CER, reflecting record production levels at the Raleigh site in North Carolina. Total H1 revenue in the Americas came out at €127.3m, up 29.1% at CER. Asia posted growth of 6.8% over the period, at €108.5m, including a persistent negative currency effect. At CER, growth totalled 11.5% in the first half, despite a slowdown in the second quarter stemming from the contraction in sales in South Korea, where access to care has been paralysed since mid-February by an unprecedented doctor strike. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 30 June 2024H1 2023*H1 2024% changeH1 2024At CER1% changeDiagnostic Imaging 336.5368.8+9.6%372.3+10.7%MRI125.0131.1+4.8%131.5+5.2%X-ray211.4237.7+12.4%240.8+13.9%Interventional Imaging42.250.4+19.5%50.9+20.8%Total378.6419.2+10.7%423.3+11.8% Diagnostic Imaging revenue amounted to €368.8m in H1 2024, up 10.7% at CER. MRI sales increased 5.2% at CER in the first half of the year thanks to a solid performance in the second quarter (+13.5%). Over this period, business was driven by a strong performance by the MRI franchise, and particularly the development of EluciremTM in the United States, together with the initial sales in Germany. X-ray revenue grew 13.9% at CER in H1 2024 as part of a positive business dynamic fuelled by sales of Xenetix® and Optiray®. In Interventional Imaging, revenue at mid-year was up 20.8% at CER. This remarkable performance reflects a strong pick-up in the second quarter (+33.8% at CER) on continued positive momentum for Lipiodol®, in terms both of volumes and prices. Solid visibility for H2 - Confirmation of financial targets for 2024 Having achieved a sustained growth trajectory in the first half of the year, Guerbet enters the second half in full peace of mind. Beyond the catch-up in sales in the Americas, business continues to benefit from firmly established growth drivers firmly across the entire portfolio: in X-rays (Optiray® in particular), Interventional Imaging (strong momentum with Lipiodol®) and the MRI franchise. The latter is now reinforced by the expansion in Europe of EluciremTM, which, after receiving an extremely favourable reception in Germany in Q2 2024, will be launched in in the UK and France in the second half. Guerbet also remains confident in improving its operating profitability, driven by the adjustment of the product mix and price increases, and in its ability to bring cash generation into positive territory. Given these circumstances, the Group is confirming its forecast of sales growth of over 8% in 2024 like-for-like and at CER and expects its adjusted EBITDA margin rate to exceed that of 2021 (14.4%). Free cash flow is expected to be in positive territory for the full year. Next event: Publication of 1st half 2024 results 25 September 2024 after market close About GuerbetAt Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 97 years, with more than 2,920 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, the United States and Israel. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €786 million in revenue in 2023. Forward-looking statementsCertain information contained in this press release does not reflect historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts, and assumptions, including but not limited to assumptions about the current and future strategy of the Group and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties, and other factors that may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly by these forward-looking statements.These forward-looking statements are valid only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to publish an update or revision of the forward-looking statements contained in this press release to reflect changes in their underlying assumptions, events, conditions, or circumstances. The forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and are generally beyond the Group’s control. These risks and uncertainties include but are not limited to the uncertainties inherent in research and development, future clinical data and analyses (including after a marketing authorization is granted), decisions by regulatory authorities (such as the US Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any application for a drug, process, or biological product filed for any such product candidates, and their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates. A detailed description of the risks and uncertainties related to the Group’s activities can be found in Chapter 4.9 “Risk factors” of the Group’s Universal Registration Document filed with the AMF (French financial markets authority) under number D.24-0224 on April 3, 2024, available on the Group’s website (www.guerbet.com). 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.2 Restated EBITDA margin rate: excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. Contacts: Guerbet Jérôme Estampes, Chief Financial Officer +33 1 45 91 50 00 / jerome.estampes@guerbet.comChristine Allard, Head of Communications +33 6 30 11 57 82 / christine.allard@guerbet.com Actifin Marianne Py, Financial Communications +33 1 80 48 25 31 / marianne.py@seitosei-actifin.com Jennifer Jullia, Press +33.1.56.88.11.19 / jennifer.jullia@seitosei-actifin.com Attachment 24 07-25 CP Guerbet CA S1 2024 VDef EN

Financial StatementBiosimilar

25 Apr 2024

·www.globenewswire.com

Guerbet : Q1 2024 revenue.

Q1 2024 revenue Quarterly activity Revenue: €194.3m, up 8.8% at CER1Growth remains particularly strong in Asia (+26.8% at CER) and the Americas (+20.1% at CER); the EMEA region (-6.2% at CER) was temporarily impacted by the reform of the supply of contrast products in France Annual targets confirmed Revenue: expected growth of over 8% like-for-like and at CERProfitability: restated EBITDA margin rate2 higher than in 2021 (14.4%) Villepinte, 25 April 2024, 5.45 pm: Guerbet (FR0000032526 GBT), a global specialist in contrast agents and solutions for medical imaging, is publishing its revenue for the first fiscal quarter. At 31 March 2024, the Group’s sales totalled €194.3m, up 7.6% compared with the same period in 2023. Given an unfavourable foreign exchange effect of €2.2m, largely linked to Asian currencies, revenue at CER1 was up 8.8% over the period. Geographical breakdown of consolidated Group revenue (IFRS) In millions of euros,at 31 March 2024Q1 2023*Q1 2024% changeQ1 2024At CER1% changeSales in EMEA89.083.9-5.8%83.6-6.2%Sales in the Americas47.557.4+21%57.0+20.1%Sales in Asia44.152.9+20%55.9+26.8%Total180.6194.3+7.6%196.5+8.8% *Revenue for Q1 2023 has been restated to include Intrasense, which has been consolidated since 1 January 2023. In the EMEA region, the Group generated revenue of €83.9m in the first quarter, down 5.8% (-6.2% at CER) mainly owing to the dip in sales volumes in France. This trend stems directly from the implementation on 1 March 2024 of the reform of the supply circuit for contrast products, which caused difficulties in order intakes with radiologists. The Group expects to largely catch up on the resulting delays in sales in the second quarter of 2024. In the Americas, sales totalled €57.4m, up 21.0% over the period (+20.1% at CER). Sales caught up strongly for the second consecutive quarter following the return to historic production levels at the Raleigh site in North Carolina. Group revenue in Asia was €52.9m, with continued strong growth momentum (+20%) driven by the performances of China, South Korea and Japan. The total includes a negative currency effect (-€3.0m) linked in particular to the further depreciation of the yen. At CER, sales in Asia rose 26.8% in first-quarter 2024, confirming the Group’s ambitions in this region. Breakdown of consolidated Group revenue (IFRS) by activity In millions of euros,at 31 March 2024Q1 2023*Q1 2024% changeQ1 2024At CER1% changeDiagnostic Imaging 160.8173.6+7.9%175.5+9.1%MRI60.758.2-4.1%58.4-3.7%X-ray100.2115.4+15.2%117.1+16.9%Interventional Imaging19.820.7+4.4%21.0+6.1%Total180.6194.3+7.6%196.5+8.8% 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.*Revenue for Q1 2023 has been restated to include Intrasense, which has been consolidated since 1 January 2023. Diagnostic Imaging revenue increased 7.9% in Q1 2024 (+9.1% at CER) to €173.6m. MRI activity was down 3.7% at CER. This decline resulted from the postponement of several substantial orders in the MRI franchise (Dotarem® / EluciremTM) in France, all of which will be booked in the second quarter of 2024.X-ray revenue increased 16.9% at CER over the period, a remarkable increase driven by all the division’s products, particularly Xenetix®. In Interventional Imaging, revenue rose 6.1% at CER in Q1 2024 on continued favourable momentum for Lipiodol®, fuelled by volumes and prices alike. All financial targets confirmed for 2024 The highly positive trend overall at the start of the year boosts Guerbet’s confidence for the full year. In a buoyant contrast products market, Group business will be bolstered by the ramp-up of the MRI franchise, growth in Optiray® sales, and continued favourable momentum for Lipiodol®. At the same time, operating profitability will benefit from the change in the product mix and the continued rise in prices, while cash generation will improve considerably, particularly as inventory levels return to normal. Given these circumstances, Guerbet is confirming its forecast of sales growth of over 8% in 2024 like-for-like and at CER and expects its adjusted EBITDA margin rate to exceed that of 2021 (14.4%). Free cash flow is expected to be in positive territory for the full year. Next events : Annual Shareholders' Meeting for fiscal year 202324 May 2024 Publication of 1st half 2024 revenue 25 July 2024 after market close About GuerbetAt Guerbet, we build lasting relationships so that we enable people to live better. That is our purpose. We are a leader in medical imaging worldwide, offering a comprehensive range of pharmaceutical products, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 97 years, with more than 2,920 employees worldwide, we continuously innovate and devote 10% of our sales to research and development in four centres in France, the United States and Israel. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated €786 million in revenue in 2023. Forward-looking statementsCertain information contained in this press release does not reflect historical data but constitutes forward-looking statements. These forward-looking statements are based on estimates, forecasts, and assumptions, including but not limited to assumptions about the current and future strategy of the Group and the economic environment in which the Group operates. They involve known and unknown risks, uncertainties, and other factors that may result in a significant difference between the Group’s actual performance and results and those presented explicitly or implicitly by these forward-looking statements.These forward-looking statements are valid only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to publish an update or revision of the forward-looking statements contained in this press release to reflect changes in their underlying assumptions, events, conditions, or circumstances. The forward-looking statements contained in this press release are for illustrative purposes only. Forward-looking statements and information are not guarantees of future performance and are subject to risks and uncertainties that are difficult to predict and are generally beyond the Group’s control. These risks and uncertainties include but are not limited to the uncertainties inherent in research and development, future clinical data and analyses (including after a marketing authorization is granted), decisions by regulatory authorities (such as the US Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any application for a drug, process, or biological product filed for any such product candidates, and their decisions regarding labeling and other factors that may affect the availability or commercial potential of such product candidates. A detailed description of the risks and uncertainties related to the Group’s activities can be found in Chapter 4.9 “Risk factors” of the Group’s Universal Registration Document filed with the AMF (French financial markets authority) under number D.24-0224 on April 3, 2024, available on the Group’s website (www.guerbet.com). 1 Constant exchange rates: the exchange rate impact was eliminated by recalculating sales for the period on the basis of the exchange rates used for the previous financial year.2 Restated EBITDA margin rate : excluding non-recurring costs related to the optimisation of the operating plan and changes in the sales model. Attachment CP CA T1 2024_VFinale EN

Financial Statement

11 Dec 2023

·www.prnewswire.com

The European Commission granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union

Following the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the European Committee (EC), the EC has granted Marketing Authorisation for Vueway® (gadopiclenol) in the European Union. Vueway® is a new, highly stable, macrocyclic gadolinium-based contrast agent (GBCA) for contrast-enhanced magnetic resonance imaging (CE-MRI): due to its high R1 relaxivity, in adequate and well controlled clinical studies it showed similar diagnostic efficacy when used at half the dose of gadobutrol, a GBCA routinely and widely used for CE-MRI1,2 Reduced dose compared with gadobutrol and other GBCAs implies reduced exposure of patients to gadolinium, and reduced release of the metal in the environment. Already approved in 2022 in the United States of America 3, where it is already used in clinical practice, Vueway® is now also approved in the European Union for use in CE-MRI of the central nervous system (CNS) and of several body organs, i.e., liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system in adult patients and paediatric patients aged 2 years and older. MILAN, Dec. 11, 2023 /PRNewswire/ -- Bracco Imaging S.p.A., an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio inclusive of precision diagnostic imaging modalities, announces that on December 7, 2023 the European Commission (EC) has granted the Marketing Authorisation for Vueway® (gadopiclenol) in the European Union (EU). The approval granted by the EC followed positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), and the recommendation sent by EMA to the EC. Vueway® (gadopiclenol) is a solution for intravenous injection approved by the EC for use with contrast-enhanced magnetic resonance imaging (CE-MRI) in adult patients and children aged 2 years and older 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) and CE-MRI of several body organs, i.e., the liver, kidney, pancreas, breast, lung, prostate, and musculoskeletal system. In September 2022, gadopiclenol was approved by the Food and Drug Administration (FDA) for its use in MRI of the CNS and the Body in the United States of America (USA) 3, where the product is used in clinical practice at an increasing number of hospital systems. Vueway® (gadopiclenol) is a new highly stable, macrocyclic gadolinium-based contrast agent (GBCA) with the highest values of longitudinal (R1) relaxivity among all the GBCAs approved for use in the EU and the USA. 4 Thanks to its high relaxivity, large, multicenter, adequate and well controlled clinical studies have shown that Vueway® provides similar diagnostic efficacy at half the dose of gadobutrol, a GBCA routinely used in clinical practice in the EU. 1,2 "The final approval of gadopiclenol by the European Commission marks a significant milestone in the field of diagnostic imaging. Its availability empowers healthcare providers with a powerful tool that can aid in the detection and assessment of a wide range of diseases and conditions," said Christian Herold, Full Professor at the Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna General Hospital Vienna, Austria. "From oncology to neurology, gastroenterology to musculoskeletal medicine, gadopiclenol has the potential to reshape the landscape of patient care across multiple specialties." The positive CHMP opinion, the EMA recommendation, and the final EC approval were based on the results from two prospective, large-scale, randomized, double-blind, crossover clinical studies, PICTURE and PROMISE, conducted in more than 500 adult patients undergoing contrast-enhanced MRI and aimed at comparing the safety and efficacy of 0.05 mmol/kg gadopiclenol compared with 0.1 mmol/kg gadobutrol1,2. The PICTURE trial demonstrated comparable diagnostic efficacy at half dose in MRI of the CNS 1, while the PROMISE trial demonstrated the same in MRI of the head and neck, chest, breast, liver, pancreas, pelvis organs, and the musculoskeletal system.2 A reduced dose compared with gadobutrol and other GBCAs implies reduced exposure of patients to gadolinium, and reduced release of the metal in the environment. "In our experience to date at MD Anderson with gadopiclenol, we have been pleased to be able to reduce our patients gadolinium exposure by half, while still achieving effective contrast enhancement. From today, European colleagues will be able to take advantage of this unique and highly potent solution," said Max Wintermark, Chairman of the Department of Neuroradiology, The University of Texas MD Anderson Cancer Center, Houston, Texas. "We are thrilled to announce this groundbreaking development, which marks a significant milestone in enhancing patient care. This innovation benefits healthcare providers but also, more importantly, patients who undergo MRI scans and those living with chronic conditions. Vueway will not only lower the rate of inaccurate or inconclusive results of MRI procedures but may also contribute to improve treatment plans tailored to individual patient needs," concluded Fulvio Renoldi Bracco, CEO Bracco Imaging SpA. About gadolinium-based contrast agents Gadolinium-based contrast agents (GBCAs) are widely and routinely used to enhance the diagnostic performance of magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) examinations.5 Gadolinium is a rare earth metal that has unique magnetic properties that make it useful for MRI imaging. About gadopiclenol Gadopiclenol, initially invented by Guerbet with subsequent contribution of Bracco intellectual property, is a new macrocyclic gadolinium-based contrast agent (GBCA) with high relaxivity. The efficacy and safety of gadopiclenol have been evaluated in MRI of the central nervous system, head and neck, thorax, abdomen, pelvis, and musculoskeletal system (For US reference, refer to the FDA approved prescribing information). Details on Phase III clinical trials are available on : Efficacy and Safety of Gadopiclenol for Central Nervous System (CNS) Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) Full Text View - ClinicalTrials.gov About the PICTURE trial1 The PICTURE trial included 256 patients with known or highly suspected CNS lesion(s). All primary and secondary endpoints of the study were achieved. All blinded readers' evaluations indicated the superiority of the combined unenhanced/contrast-enhanced MRI with 0.05 mmol/kg gadopiclenol over unenhanced MRI alone for all lesion visualisation criteria (p<0.0001). For all three blinded readers, non-inferiority of 0.05 mmol/kg gadopiclenol to 0.1 mmol/kg gadobutrol (Gadavist) was demonstrated for all lesion visualisation criteria (p<0.0001). Results also indicated superior percent of contrast enhancement for all readers (p<0.0001), superior contrast-to-noise ratio for two out of three readers (p<0.01), and superior lesion-to-background contrast ratio with gadopiclenol for all readers (p<0.0001). In correlation with the greater contrast enhancement, the diagnostic quality of the images obtained with 0.05 mmol/kg gadopiclenol were in majority preferred over that provided by 0.1 mmol/kg gadobutrol by all three blinded readers (p<0.001). About the PROMISE trial2 The PROMISE trial included 273 adult patients suspected of having an enhancing abnormality in one of three different body regions (head/neck, breast/thorax/abdomen/pelvis, or musculoskeletal). Off-site blinded readers with expertise in the respective body regions rated border delineation, internal morphology, and visual contrast enhancement. All primary and secondary endpoints of the study were achieved. For all blinded readers, 0.05 mmol/kg gadopiclenol was non-inferior to 0.1 mmol/kg gadobutrol for all visualisation parameters and all readers (P<.001), and superior to unenhanced images (P<.001). Two of three readers yielded higher percentage enhancement for gadopiclenol (P<.001). Lesion-to-background ratio did not differ. For most participants (75%–83%), readers reported no preference between 0.05 mmol/kg gadopiclenol and 0.1 mmol/kg gadobutrol images. About Bracco Imaging Bracco Imaging S.p.A. ("Bracco Imaging"), part of the Bracco Group, is an innovative world leader delivering end-to-end products and solutions through its comprehensive portfolio across diagnostic imaging modalities. Headquartered in Milan, Italy, Bracco Imaging's purpose is to improve people's lives by shaping the future of prevention and precision diagnostic imaging. The Bracco Imaging portfolio includes products and solutions for all key diagnostic imaging modalities: X-ray imaging, magnetic resonance imaging (MRI), Contrast Enhanced Ultrasound (CEUS), and Nuclear Medicine through radioactive tracers and novel PET imaging agents. Bracco Imaging has approximately 3,700 employees and operates in more than 100 markets globally. Bracco Imaging has a well-skilled and innovative Research and Development (R&D) organization with an efficient process-oriented approach and track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the United Kingdom and the United States. Bracco Group global revenues were 1.7 billion Euros in 2020. To learn more about Bracco Imaging, visit . THE BRACCO IMAGING AND GUERBET COLLABORATION Bracco Imaging and Guerbet in December 2021 entered a worldwide collaboration on Gadopiclenol manufacturing and research and development activities. Gadopiclenol will be commercialized independently under separate brands. Both Guerbet and Bracco Imaging each own valuable intellectual property on Gadopiclenol. Furthermore, after an agreed transition period when Guerbet manufactures Gadopiclenol for both Guerbet and Bracco, both companies will manufacture the Gadopiclenol active ingredient and finished product. The strategic collaboration is expected to accelerate access to Gadopiclenol and deliver innovation, as well as better care to patients and caregivers alike. Bracco Imaging Micaela Colamasi PR Manager [email protected] +39 348 2314362 1 Loevner LA, Kolumban B, Hutóczki G, et al. Efficacy and Safety of Gadopiclenol for Contrast-Enhanced MRI of the Central Nervous System: The PICTURE Randomized Clinical Trial. Invest Radiol 2023; 58:307-313 2 Kuhl C, Csőszi T, Piskorski W, Miszalski T, Lee JM, Otto PM. Efficacy and Safety of Half-Dose Gadopiclenol versus Full-Dose Gadobutrol for Contrast-enhanced Body MRI. Radiology 2023; 308: e222612 3 Food and Drug Administration. Novel Drug Approvals in 2022. Available at: . Accessed December 8, 2023 4 Robic C, Port M, Rousseaux O, et al. Physicochemical and pharmacokinetic profiles of gadopiclenol: a new macrocyclic gadolinium chelate with high T1 relaxivity. Invest Radiol 2019; 54: 475-484 5 FDA. Information on Gadolinium-Based Contrast Agents. . Accessed December 8, 2023 SOURCE Bracco

Clinical ResultPhase 3Drug Approval

100 Deals associated with Gadopiclenol

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Approved

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Indication	Country/Location	Organization	Date
Contrast agents	EU	Bracco Imaging SpA	11 Dec 2023
Contrast agents	IS	Bracco Imaging SpA	11 Dec 2023
Contrast agents	LI	Bracco Imaging SpA	11 Dec 2023
Contrast agents	NO	Bracco Imaging SpA	11 Dec 2023
Diagnostic agents	EU	Guerbet SA	07 Dec 2023
Diagnostic agents	EU	Bracco Imaging SpA	07 Dec 2023
Diagnostic agents	IS	Guerbet SA	07 Dec 2023
Diagnostic agents	IS	Bracco Imaging SpA	07 Dec 2023
Diagnostic agents	LI	Guerbet SA	07 Dec 2023
Diagnostic agents	LI	Bracco Imaging SpA	07 Dec 2023
Diagnostic agents	NO	Bracco Imaging SpA	07 Dec 2023
Diagnostic agents	NO	Guerbet SA	07 Dec 2023
Central Nervous System Diseases	US	Guerbet LLC	21 Sep 2022
Vascular Diseases	US	Guerbet LLC	21 Sep 2022

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Heart Defects, Congenital	Phase 3	US	Bracco Imaging SpA	01 May 2024
Brain Stem Glioma	Phase 3	HU	Guerbet LLC	07 Sep 2023
Brain Stem Glioma	Phase 3	IT	Guerbet LLC	07 Sep 2023
Brain Stem Glioma	Phase 3	PL	Guerbet LLC	07 Sep 2023
Glioma	Phase 3	HU	Guerbet LLC	07 Sep 2023
Glioma	Phase 3	IT	Guerbet LLC	07 Sep 2023
Glioma	Phase 3	PL	Guerbet LLC	07 Sep 2023
Blood brain barrier defect	Phase 3	US	Guerbet LLC	03 Jun 2019
Blood brain barrier defect	Phase 3	BE	Guerbet LLC	03 Jun 2019
Blood brain barrier defect	Phase 3	FR	Guerbet LLC	03 Jun 2019

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


phase IIb study (ASCO2024)	Phase 2	Brain metastases	13	Gadopiclenol 0.1 mmol/kg	nyffoklihf(gfclaaiyvv) = bukrmwvemx djaltoyiun (sydzcgwknh ) View more	Positive	24 May 2024
NCT03749252 (CTgov)	Phase 2	Central Nervous System Diseases	80	P03277 (CNS Cohort 2-6 Years)	fihemlbowf(czmljinfdf) = ircevaaahg teyfblpigy (wbuifyklbv, jsbsxedytz - clpykqpbfs) View more	-	01 Jun 2022
				P03277 (CNS Cohort 7-11 Years)	fihemlbowf(czmljinfdf) = sgnhfnqhyd teyfblpigy (wbuifyklbv, zpraloqjbc - phheynjkbj) View more
NCT02973516 (CTgov)	Phase 2	Hepatocellular Carcinoma \| Chronic liver disease	41	Gadopiclenol (Cohort 1)	ijrwwbflri(jpqsjsdksb) = ppkzhyjlgr kvekgywgaa (qgmrkjkhke, vpsrqiburr - mrkiftuqob) View more	-	06 Oct 2021
				Gadopiclenol (Cohort 2)	ijrwwbflri(jpqsjsdksb) = guqrufobcd kvekgywgaa (qgmrkjkhke, tyzaieifam - qsalitllda) View more
NCT03657784 (Pubmed \| Invest Radiol)	Phase 1	Renal Insufficiency	40	Gadopiclenol (Healthy subjects)	(njgkbfyefo) = rfclubarub rlmszgtpwz (ouevocgatm )	-	01 Aug 2021
				Gadopiclenol (Subjects with mild renal impairment)	(njgkbfyefo) = fnleimkfdg rlmszgtpwz (ouevocgatm )
NCT03996447 \| NCT03986138 (PICTURE \| PROMISE, Corporate Publications) Manual	Phase 3	Contrast agents	560	Gadopiclenol+gadobutrol	vuhtjzrzad(mpfdcecoen) = the non-inferiority of Gadopiclenol (0.05 mmol/kg) compared to Gadobutrol (0.1 mmol/kg) for the visualization and detection of lesions of the central nervous system and in the other anatomical areas studied. csdilaobpo (cknoanhzvc ) View more	Positive	24 Mar 2021
				Gadobutrol+Gadopiclenol
NCT03603106 (Pubmed \| Invest Radiol)	Phase 1	Visible Lesion	142	Gadopiclenol	ckuqfuxgfa(hwhrtqcszi) = dbgevyyvsy tjujqdxjvo (aetchvayyr )	-	01 Jul 2019

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