Gadoquatrane

Berlin, February 22, 2023 – Bayer announced today that new data from the company’s advanced radiology portfolio will be presented at the 2023 European Congress of Radiology (ECR), taking place from March 1-5 in Vienna, Austria. The presentations reflect Bayer’s commitment as a leading company in key radiology areas to accelerate innovation for the benefit of patients and their physicians, including leveraging the vast potential of artificial intelligence (AI). A key presentation highlights new clinical data on the novel development compound gadoquatrane, a next generation macrocyclic gadolinium-based contrast agent (GBCA) which is currently in Phase II of clinical development and planned to enter Phase III later this year. Gadoquatrane features high stability as well as high relaxivity, which is a key property for use in contrast-enhanced magnetic resonance imaging (MRI). High relaxivity has in general the potential to enable a substantially lower gadolinium (Gd) dose. The study investigated the dose-response of gadoquatrane compared to a standard dose of gadobutrol, a well-established macrocyclic GBCA. Potential ways to reduce the contrast media dose with the sharper injection bolus profile from the MEDRAD TM Centargo CT Injection System, the latest addition to Bayer’s computed tomography portfolio designed to simplify radiology workflows, are the focus of another presentation at ECR. Bayer’s research and development projects to be presented at ECR also include the topic of artificial intelligence and digital tools and how to leverage their vast potential in medical imaging. One of Bayer’s featured presentations focuses on the potential value of a learning algorithm in liver imaging, a key diagnostic area for Bayer’s radiology team. The presence of AI in radiology has grown quickly with over 200 AI applications having received a CE mark for the European market so far. While the potential for AI in radiology continues to be realized, the confidence in selecting the best applications and implementing them remains in question. Against this background, another presentation explores available publications evaluating the real-world performance of AI applications to help radiologists and their teams with insights for their clinical practice. These research and development activities to be presented at ECR showcase Bayer’s advanced position in digital and AI powered medical imaging, bolstered by the recent acquisition of the global strategic imaging AI platform and solutions provider Blackford Analysis as well as the recent launch of Calantic TM Digital Solutions – a new platform delivering access to digital applications, including artificial intelligence enabled programs, for medical imaging. On the occasion of ECR 2023, Bayer will announce that it will partner with app developers Mediaire, Coreline, and ScreenPoint Medical to strategically expand the offering on Calantic Digital Solutions. With these new collaboration agreements, Bayer is broadening the already available options on the platform by including tools which aim to aid in neuro, cardiac and breast imaging. Notable data to be presented by Bayer at the meeting and additional information about the topics are listed below. More information on the ECR program can be found here . Gadoquatrane A randomized, 4 x 4 cross-over study to investigate the dose-response of the new high relaxivity GBCA gadoquatrane in comparison to the standard dose of gadobutrol o This dose-response MRI study investigated the signal enhancement properties as well as pharmacokinetics and safety of the novel tetrameric macrocyclic GBCA gadoquatrane at various dose levels. o Gadoquatrane showed a positive benefit-risk profile and was well tolerated with no apparent difference in incidence of treatment emergent adverse events with increasing doses or compared to gadobutrol. AI- and digital-focused research The use of artificial intelligence to aid identification of intracerebral hemorrhage and large vessel occlusion: a systematic review o   This systematic literature review and meta-analysis seeks to identify publications that evaluated the real-world performance of AI applications and compare the results to the clinical validation performance. The focus is on AI applications indicated to rapidly identify intracranial hemorrhage (ICH) or large vessel occlusion (LVO). o   The findings from this review offer a perspective for comparison between clinical validation studies and real-world performance, offering some confidence that data from clinical validation studies will translate to real-world settings. Time series clustering of Primovist MRI signal enhancement o   After intravenous injection, the liver-specific MRI contrast agent Primovist distributes into the vascular and extravascular spaces and progressively into the hepatocytes and bile ducts. This happens at phases referred to as dynamic and hepatobiliary phase. o   This early research study investigated which characteristic phases an unsupervised learning algorithm applied the Signal Enhancement time curves discovers. Centargo/Contrast media dose reduction A previously unknown factor of contrast media injections enables potential for dose reduction in CT: a phantom and animal study o   This early research study assessed the impact of differences in injected bolus profiles on vascular and parenchymal enhancement. o   Two injection systems with identical programmed injections (the same contrast media volume and flow rate) show differences in actual injected bolus profile due to differences in fluid delivery technology. This resulted in differences in both vascular and parenchymal peak attenuation. o   Sharper injected bolus profiles resulted in equivalent peak attenuation with a notable reduction in administered contrast agent doses. Personalized scan protocols for CT angiography: an experimental study for contrast media or radiation dose optimization o   For personalized medicine in radiology, particularly in computed tomography, individualized scan and contrast protocols are required. o   This early research indicated a potential reduction in contrast agent dose or radiation dose for thoracoabdominal CTA can be achieved using automated tube voltage selection systems (ATVS) while maintaining objective and subjective image quality. o   The study was performed in cooperation with Bayer AG. Further Research Longterm evaluation of Gd presence in the skin and intraepidermal nerve fiber density in rats after multiple administrations of gadolinium-based contrast agents o   Gadolinium presence in the body after repeated administration of GBCAs has triggered intensive non-clinical research. o   While most studies focused on Gd presence in brain, the current study evaluated the skin of animal foot pads for Gd presence and neuro-histological changes after multiple GBCA exposure. o   No signs for small fiber neuropathy in the skin of the foot pads were observed. In addition, Bayer’s Radiology team will present the launch of the MEDRAD TM MRXperion MR Multi-Patient Disposable Kit, which can be utilized for multiple patients for up to 24 hours. The Multi-Patient Kit provides customers with the option to reduce time to change and refill syringes in between patients, thereby improving efficiency, lowering per-patient costs, and reducing waste. Furthermore, the MEDRAD TM Injection System MRXperion has expanded its MRI field strength compatibility (0.55T – 7T). About Radiology at Bayer As a true life-science company with a heritage of over 100 years in Radiology, Bayer is committed to providing excellence, from innovative products to high-quality services, to support efficient and optimized patient care. Bayer offers a leading portfolio of contrast media for computed tomography (CT), X-Ray, and magnetic resonance imaging (MRI), devices for their precise administration, informatics solutions and a medical imaging platform delivering access to applications, including those enabled by AI. Bayer’s Radiology products generated a total of €1.8bn sales in 2021. Based on the company’s ambition to outperform the radiology market’s average annual growth rate of 5% by 2030, Bayer is highly committed to research and development, which includes leveraging artificial intelligence and driving innovation in medical imaging. Each of these offerings provides effective tools to support radiologists in their mission to deliver treatment-critical answers and a clear direction – from diagnosis to care. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on Twitter: @BayerPharma Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

New clinical data for the development compound gadoquatrane, a novel MRI contrast agent, presented at RSNA 2022 Three new partnerships, AI app accelerator program and pipeline updates to be featured Collaboration agreements signed to expand offerings on new medical imaging platform CalanticTM Digital Solutions across key disease areas Abstract: No 6096, Session No R5A-SPNR BERLIN, Germany I November 22, 2022 I Bayer moves ahead with the advancement of its comprehensive Radiology portfolio with progress on the development pipeline of new contrast agents as well as further partnerships in its digital business. The company announced today the presentation of new early clinical data for gadoquatrane, Bayer’s novel macrocyclic gadolinium-based compound currently in Phase II development, at the Radiological Society of North America (RSNA) Annual Meeting. The 2022 RSNA will take place from November 27 to December 1 in Chicago, USA. In addition, Bayer announced three collaboration agreements for its digital platform Calantic™ Digital Solutions as well as an AI accelerator program, reflecting the company’s commitment to driving innovations that benefit patients and their physicians, including leveraging the vast potential of artificial intelligence (AI). Pipeline progress on new contrast agents as well as medical devices Bayer is making progress with its portfolio of contrast agents and injectors. The US submission of the MEDRAD TM Centargo CT Injection System, the latest addition to Bayer’s computed tomography portfolio designed to simplify radiology workflows, is underway. In the area of contrast agents, gadoquatrane, Bayer’s novel macrocyclic gadolinium-based compound in Phase II, is progressing in development. New early clinical data for gadoquatrane are being presented at this year’s RSNA: · Pharmacokinetics, Safety and Tolerability of a Novel Tetrameric, High Relaxivity, Macrocyclic Gadolinium-based Contrast Agent Gadoquatrane for CE-MRI o   Gadoquatrane features high stability as well as high relaxivity, which is a key property for use in contrast-enhanced magnetic resonance imaging, with the potential to enable a substantially lower gadolinium dose. The present study investigated its pharmacokinetics including excretion pathways, safety and tolerability in healthy volunteers. o Abstract No. 6096, Session Number: R5A-SPNR; Dec 1; 12:15 - 12:45 PM Fostering innovation in Radiology AI On the occasion of RSNA 2022, Bayer also announced that it will partner with app developers Quantib, ClariPi, and EXINI Diagnostics to strategically expand the offering on its medical imaging platform Calantic TM Digital Solutions. The platform, which was launched recently, delivers access to applications, including those enabled by AI, for medical imaging. With these new collaboration agreements, Bayer is broadening the already available options for thoracic and neurological diseases on the platform by including tools which aim to aid in breast and prostate imaging. With cancer and cardiovascular diseases on the rise, the demand for medical imaging to detect diseases, guide treatment decisions, and aid in therapy planning is growing. AI comes with the value proposition to support diagnosis and increase the throughput of medical imaging examinations. In addition, Bayer has recently launched Calantic TM SPARK, a new accelerator program for medical imaging app developers to further foster innovation in radiology AI. The program will initially focus on North America and Europe and is planned to be expanded to other regions including Asia-Pacific. Bayer offers a targeted program to accelerate market readiness for early- and late-stage projects and offerings, providing advice spanning medical, regulatory, reimbursement expertise, and market access. Tapping the thriving start-up ecosystem of AI in medical imaging, Calantic SPARK provides program participants with a potential pathway towards commercialization and distribution through Calantic Digital Solutions. Details about Calantic SPARK will be presented at Bayer’s booth as well as the AI Showcase Theatre at the RSNA. About Radiology at Bayer Everyone deserves clear answers about their health, starting with an early and accurate diagnosis. As a true life science company with a heritage of over 100 years in radiology, Bayer is committed to providing excellence, from innovative products to high-quality services. Bayer has a leading portfolio of contrast media for computed tomography (CT), X-ray, and magnetic resonance imaging (MRI), devices for their precise administration, informatics solutions to support efficient and optimized patient care, as well as acknowledged educational programs, that generated sales of 1.8 billion euros in 2021. In line with the company’s ambition to outperform the radiology market’s average annual growth of 5 percent by 2030, Bayer is strongly committed to research and development, which includes leveraging artificial intelligence and driving innovation in medical imaging. Each of these offerings provides effective tools to support radiologists in their mission to deliver treatment-critical answers and a clear direction – from diagnosis to care. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com/ Follow us on Facebook: http://www.facebook.com/bayer Follow us on Twitter: @BayerPharma SOURCE: Bayer