Guerbet (Paris, France) and Bracco Imaging S.p.A. (Milan, Italy) have signed a global collaboration for Gadopiclenol, a next-generation magnetic resonance imaging (MRI) contrast agent, that will result in the companies commercializing the product independently under different brand names. The companies will also collaborate on manufacturing, as well as research and development for future indications.
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 each own valuable intellectual property relating to Gadopiclenol.
Guerbet will manufacture Gadopiclenol active ingredient and vials for Bracco 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 US and the European Union (EU), with other geographies to follow.
"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."
Bracco Imaging S.p.A.