Guerbet and Bracco Imaging Announce a Global Strategic
Collaboration Agreement for Gadopiclenol
Guerbet and Bracco Imaging Announce a
Global Strategic Collaboration Agreement for
Gadopiclenol
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
December 14, 2021 (7:00 a.m. CET)
– 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.
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 €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
Jérôme
Estampes.Chief Financial Officer+33 (0)1 45 91 50
00 Anne-Laure DelasalleGlobal Communications
Director+33 (0) 1 45 91 50
00anne-laure.delasalle@guerbet.com |
Benjamin
LehariFinancial Communications+33 (0)1 56 88 11
25blehari@actifin.fr Jennifer JulliaPress
Briefings+33 (0)1 56 88 11
19jjullia@actifin.fr |
Duccio
ManettiGlobal Communications Director+39 340
9016191Duccio.Manetti@bracco.com Giuliano
FalivaCorporate Communications Director+39 335
5980048Giuliano.Faliva@bracco.com |
Shannon
SuskoMedia Contact+001
646-200-1826BraccoMedia@edelman.com |
- Guerbet and Bracco Press Release-December 14 2021-Final
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