Guerbet and Bracco Imaging Announce Global Strategic Collaboration Agreement for Gadopiclenol

The companies will collaborate on manufacturing and research and development for future indications, and market gadopiclenol independently under separate brands.

Gadopiclenol is a new generation macrocyclic contrast agent with high relaxation, intended to improve the detection and visualization of lesions on MRI, with doses of gadolinium lower than those of other agents on the market.

Guerbet and Bracco Imaging will seek regulatory approval to market Gadopiclenol in United States and the European Union in 2023, with other geographies to follow

Milan, italy, December 14, 2021 / PRNewswire / – Guerbet (FR0000032526 GBT), a global leader in medical imaging offering a full line of pharmaceuticals, medical devices, and digital and artificial intelligence (AI) solutions for diagnostic and interventional imaging, and Bracco Imaging, an innovative world leader delivering end-to-end products and solutions through a comprehensive portfolio including precision diagnostic imaging modalities, today announced the signing of a global collaboration for Gadopiclenol, an agent next-generation magnetic resonance imaging (MRI) contrast media. This global collaboration will allow Guerbet and Bracco Imaging to market the product independently under different brands. The companies will also collaborate on manufacturing, as well as research and development for future indications. Financial terms of the transaction are not being disclosed.

A new generation gadolinium-based macrocyclic contrast agent with high relaxivity, gadopiclenol is intended to improve the detection and visualization of lesions on MRI, with lower doses of gadolinium compared to other agents already on the market. In March 2021, positive results from two Phase III studies comparing the diagnostic efficacy and safety of Gadopiclenol, which uses half the dose of gadolinium compared to Gadobutrol, in a wide range of indications, covering the central nervous system and various others anatomical areas (head and neck, thorax, breast, abdomen, pelvis, musculoskeletal system) have been published by Guerbet. Guerbet and Bracco Imaging each own valuable intellectual property relating to Gadopiclenol.

“Gadopiclenol will be an excellent extension of Guerbet’s UNIK MRI solutions of contrast media, injectors, consumables, services and software. It will allow our clients to use a lower dose of gadolinium in their daily clinical practice. Our ambition is to make it available to It is a bold decision that will accelerate our ability to further develop Gadopiclenol, which will bring significant health benefits around the world ”, said the CEO of Guerbet, David hale

“Gadopiclenol represents a real and valuable innovation in MRI, with a unique profile of stability and contrast enhancement properties that will allow a low dose to be used effectively in a large number of clinical settings and clinical indications,” said said Fulvio Renoldi, CEO of Bracco Imaging. Bracco. “We are excited about this strategic addition to Bracco Imaging’s MRI portfolio. Once approved, the addition of Gadopiclenol will expand our portfolio to include three different products that will help shape the future of prevention and precision diagnostic imaging, in line with our global strategy. ”

Guerbet will manufacture the active ingredient and Gadopiclenol vials for Bracco Imaging for up to seven years. Following a technology transfer, the two companies will have the capacity to manufacture the product. The first marketing authorizations are expected in 2023, initially in United States and the European Union (EU), with other geographic areas to follow.

About gadopiclenol

Gadopiclenol is a new macrocyclic contrast agent based on gadolinium with high relaxivity (contrast power), designed and developed by the Guerbet R&D team. The efficacy and safety of Gadopiclenol has been evaluated as part of the company’s clinical development plan for global marketing authorization. No regulatory authority has evaluated the clinical study data for this product to date. Details of the Phase III clinical trials are available in the ClinicalTrials.gov database:

  • Efficacy and Safety of Gadopiclenol for Magnetic Resonance Imaging (MRI) of the Central Nervous System (CNS) – Full Text View – ClinicalTrials.gov
  • Efficacy and Safety of Gadopiclenol for Body Magnetic Resonance Imaging (MRI) – Full Text View – ClinicalTrials.gov

All this data will serve as the basis for regulatory submissions, which will begin in United States and in the European Union (EU) in early 2022.

About Guerbet

At Guerbet, we build lasting relationships to enable people to live better lives. This is our goal. We are a global leader in medical imaging, offering a full line of pharmaceuticals, medical devices, and digital and AI solutions for diagnostic and interventional imaging. A pioneer in contrast media for 95 years, with more than 2,600 employees worldwide, we are constantly innovating and devoting 10% of our turnover to research and development in four centers in France, Israel, and United States. Guerbet (GBT) is listed on Euronext Paris (segment B – mid caps) and generated € 712 million in sales in 2020. For more information, visit www.guerbet.com.

About Bracco Imaging

Bracco Imaging SpA (“Bracco Imaging”), part of the Bracco Group, is an innovative global leader providing end-to-end products and solutions through its comprehensive portfolio of diagnostic imaging modalities. Based at Milan, italy, Bracco Imaging’s goal 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 major diagnostic imaging modalities: x-ray imaging, magnetic resonance imaging (MRI), contrast enhanced ultrasound (CEUS) and nuclear medicine. Bracco Imaging has approximately 3,600 employees and operates in more than 100 markets around the world. Bracco Imaging has a well-qualified and innovative research and development (R&D) organization with an efficient process-driven approach and a track record in the diagnostic imaging industry. R&D activities are located in four centers based in Italy, Switzerland, the UK and United States. The worldwide revenues of the Bracco group have been 1.4 billion euros in 2020. To learn more about Bracco Imaging, visit www.braccoimaging.com.

Guerbet forward-looking statements

Certain 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 regarding the current and future strategy of the Guerbet Group (“Group”) and the economic environment in which the Group operates.

They involve known and unknown risks, uncertainties and other factors which may cause a significant difference between the actual performance and results of the Group and those presented explicitly or implicitly by these forward-looking statements.

These forward-looking statements speak only as of the date of this press release, and the Group expressly disclaims any obligation or commitment to issue any 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 illustration 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 which are generally beyond the control of the Group.

These risks and uncertainties include, but are not limited to, uncertainties inherent in research and development, in future clinical data and analyzes (including after the granting of a marketing authorization), in the decisions of the authorities. regulations (such as the United States Food and Drug Administration or the European Medicines Agency) regarding whether and when to approve any drug, process or biologic application filed for such product candidates, as well as their decisions regarding labeling and other factors that may affect the availability or commercial potential of these product candidates.

A detailed description of the risks and uncertainties associated with the Group’s activities can be found in chapter 4.8 “Management and risk factors” of the Group’s Universal Registration Document filed with the AMF under number D-20-0369 on April 28, 2020, available on the Group’s website (www.guerbet.com).

Contacts

Guerbet

Actifin



Jérôme Prints.

Financial director

+33 (0) 1 45 91 50 00

Anne-Laure Delasalle

Global Communications Director

+33 (0) 1 45 91 50 00

[email protected]

Benjamin Lehari

Financial communication

+33 (0) 1 56 88 11 25

[email protected]

Jennifer jullia

Press briefings

+33 (0) 1 56 88 11 19

[email protected]

Bracco Imaging

Edelman



Duccio Manetti

Global Communications Director

+39 340 9016191

[email protected]

Giuliano Faliva

Director of Corporate Communications

+39 335 5980048

[email protected]

Shannon susko

Media contact

+001 646-200-1826

[email protected]

Bracco Group

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