PR93656

MILAN, Italy, Dec. 14, 2021 /PRNewswire=KYODO JBN/ --

- Companies will collaborate on manufacturing and research and development for

future indications, and will commercialize Gadopiclenol independently under

separate brands

- Gadopiclenol is a next-generation, macrocyclic contrast agent with

high-relaxivity, intended to improve lesion detection and visualization in MRI,

with lower doses of gadolinium compared to other agents on the market

- Guerbet and Bracco Imaging will seek regulatory approval to market

Gadopiclenol in the United States and the European Union in 2023, with other

geographies to follow

Guerbet (FR0000032526 GBT), a global leader in medical imaging offering a

comprehensive range of pharmaceutical products, 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 inclusive of precision

diagnostic imaging modalities, today announced they have signed a global

collaboration for Gadopiclenol, a next-generation magnetic resonance imaging

(MRI) contrast agent. This global collaboration will result in Guerbet and

Bracco Imaging commercializing the product independently under different brand

names. The companies will also collaborate on manufacturing, as well as

research and development for future indications. Financial terms of the

transaction are not disclosed.

Logo -

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A next-generation, macrocyclic gadolinium-based contrast agent with high

relaxivity, Gadopiclenol is intended to improve lesion detection and

visualization in MRI scanning, 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 other anatomical

areas (head and neck, thorax, breast, abdomen, pelvis, musculoskeletal system)

were published by Guerbet. Both 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 enable

our customers to use a lower dose of gadolinium in their everyday clinical

practice. Our ambition is to make this available to as many patients as soon as

possible. This is a bold decision which will accelerate our ability to further

develop Gadopiclenol, which will bring significant health benefits worldwide,"

said CEO of Guerbet, David Hale

"Gadopiclenol represents real and valuable innovation in MRI, with a unique

profile of stability and contrast enhancement properties that will allow a low

dose to be effectively used in a large number of clinical settings and clinical

indications," said CEO of Bracco Imaging, Fulvio Renoldi 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 to shape the future of prevention and

precision diagnostic imaging, in accordance with our global strategy."

Guerbet will manufacture Gadopiclenol active ingredient and vials for Bracco

Imaging for up to seven years. Following a technology transfer, both companies

will have the ability to manufacture the product. The first marketing

authorizations are anticipated in 2023, initially in the United States and the

European Union (EU), with other geographies to follow.

About Gadopiclenol

Gadopiclenol is a new macrocyclic gadolinium-based contrast agent with high

relaxivity (contrast power), designed and developed by Guerbet's R&D team. The

efficacy and safety of Gadopiclenol have been evaluated as part of the

company's clinical development plan with a view to obtaining worldwide

marketing authorization. No regulatory authority has evaluated the clinical

study data for this product to date. Details on Phase III clinical trials are

available in the ClinicalTrials.gov database:

    -- 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

All these data will serve as a basis for regulatory submissions, which will

begin in the United States and in the European Union (EU) early 2022.

About Guerbet

At 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 95 years, with more than 2,600 employees worldwide, we

continuously innovate and devote 10% of our sales to research and development

in four centers in France, Israel, and the United States. Guerbet (GBT) is

listed on Euronext Paris (segment B - mid caps) and generated EUR 712 million

in revenue in 2020. For more information, please visit www.guerbet.com.

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. 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. Bracco Imaging has

approximately 3,600 employee 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 1.4 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 about 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 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, as

well as 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 4.8 "Management and risk factors" of the

Group's Universal Registration Document filed with the AMF (French financial

markets authority) under number D-20-0369 on April 28, 2020, available on the

Group's website (www.guerbet.com).

Contacts

Guerbet:

Jerome Estampes

Chief Financial Officer

+33 (0)1 45 91 50 00

Anne-Laure Delasalle

Global Communications Director

+33 (0) 1 45 91 50 00

anne-laure.delasalle@guerbet.com

Actifin : 

Benjamin Lehari

Financial Communications

+33 (0)1 56 88 11 25

blehari@actifin.fr

Jennifer Jullia

Press Briefings

+33 (0)1 56 88 11 19

jjullia@actifin.fr

Bracco Imaging:                    

Duccio Manetti                     

Global Communications Director     

+39 340 9016191                   

Duccio.Manetti@bracco.com         

Giuliano Faliva

Corporate Communications Director

+39 335 5980048

Giuliano.Faliva@bracco.com

Edelman:

Shannon Susko

Media Contact

 +001 646-200-1826

BraccoMedia@edelman.com

SOURCE  Bracco Group