Press Contact: David Pitts Argot Partners 212.600.1902 [email protected]
Bracco Imaging Continues its Investment in Delivering Radiological Solutions
Growing Breadth of Portfolio, Research, Education and Innovation Initiatives Highlighted at the 2011 RSNA
CHICAGO, November 27, 2011 – Bracco Imaging S.p.A. – one of the world’s leading companies in the diagnostic imaging business and part of the Bracco Group – is highlighting the Company’s investment and commitment to imaging agents and radiology solutions across modalities through its growing product portfolio, as well as research, education and innovation, at the 97th Scientific Assembly and Annual Meeting of the Radiological Society of North America (RSNA), which is being held November 27 - December 2, 2011 at Chicago’s McCormick Place, booth #4839.
"Bracco remains committed to the diagnostic imaging sector, investing in imaging across modalities, including X-ray, Computed Tomography (CT), Cath Lab, Magnetic Resonance Imaging (MRI), Nuclear Medicine and Ultrasound," according to Fulvio Renoldi Bracco, head of Bracco Imaging, S.p.A. "In a difficult economic climate, where investing in the future is not top of mind, Bracco remains at the forefront. We believe that imaging agents and integrated imaging solutions are critical to support radiologists and other imaging specialists in making an effective diagnosis. Our commitment to providing the market with industry-leading products and solutions, and our partnership with the medical community, therefore remains unchanged." Fulvio Renoldi Bracco concluded: "We perceive this period in the industry, and indeed in the broader markets, as an opportunity to invest and to continue to deliver the best contrast imaging solutions to market. Our investments span the gamut from new product additions to acquiring key distribution channels such as the Nycomed manufacturing facilities in Singen, where Bracco contrast agents are manufactured, to establishing a direct presence early next year in Poland, Slovakia and the Czech republic.”
In the last few years, Bracco acquired and developed solutions for contrast administration. The ACIST CVi® injectors are today the leader in the cardiac catheterization segment and the Empower injectors for CT and MRI are gaining market acceptance all around the world.
At the 2011 RSNA, Bracco presents a further evolution of the Empower CTA injector with a significant improvement in efficiency and with new connectivity breakthrough features allowing exchange of data with radiology information systems (RIS) and picture archiving and communication systems (PACS). This connectivity simplifies workflow allowing users to effectively document and communicate injection information. The information is automatically structured and sent into the PACS so that the radiologist can see it.
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Continuing on this solutions path, in August 2011, Bracco announced the acquisition of Swiss Medical Care, a company engaged in the research, production and marketing of automated systems for the administration of contrast agents for diagnostic imaging. Swiss Medical Care’s primary product, CT Exprés 3D™, an automated, 3-channel syringe-less contrast media injector for CT examinations, represents significant advances in cost management, workflow and automation.
“The acquisition of Swiss Medical Care is a key example of our global investment and continued commitment to being the ‘complete contrast imaging solutions provider’," added Carlo Medici, Head of Global Commercial Operations of Bracco Imaging S.p.A. and President and Chief Executive Officer, Bracco Diagnostics Inc. Our value proposition of providing clinically proven products with an array of support services distinguishes us as a preferred choice for optimal and effective patient management in the diagnostic imaging industry. This customer preference is demonstrated by our holding the number one position in X-ray with Isovue® (iopamidol injection), and our being a formidable number two player in MR imaging, based on U.S. market share figures. Our GPO footprint expansion continues as evidenced by our recent award of Premier.”
Bracco’s products provide market leading contrast solutions in X-ray, CT, Cardiac Cath Lab, Diagnostic Radiology and MR suites including products Isovue, MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL, ProHance® (gadoteridol) injection, 279.3 mg/mL, and barium contrast products. Bracco contrast solutions offer safe and effective contrast enhancement while offering efficient and optimal protocols and imaging performance.
Mr. Medici concluded: "In addition to investing in our expansion, Bracco has put significant resources behind research which distinguishes our market leading products. MultiHance, for example, has demonstrated that it can provide increased visualization thanks to its higher relaxivity. Such investments are hallmarks of Bracco's commitment to clinical and scientific evidence."
About Isovue More than 290 million doses of iopamidol have been administered worldwide since 1992.1 Indicated for a wide variety of radiographic, angiographic and CT indications, Isovue offers desired flexibility by providing a wide range of iodine concentrations and packaging options. Isovue-M is specifically packaged and labeled for intrathecal use. Clinical applications for Isovue-M include intrathecal administration in adult neuroradiology, including myelography, contrast enhancement of CT cisternography and ventriculography, and thoraco-lumbar myelography, in children over the age of two years old.
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1 Periodic Safety Update Report Data, 2011, data on file, Bracco Diagnostics Inc. Bracco Imaging at RSNA 2011
IMPORTANT SAFETY INFORMATION for Isovue: Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media. Clotting has been reported when blood remains in contact with syringes containing nonionic contrast media. Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. As with all injectable contrast agents, the possibility of severe reactions should be borne in mind, regardless of the patient’s pre-existing medical history. As with any other iodinated contrast media, caution must be exercised in patients with severely impaired renal function, combined renal and hepatic disease, combined renal and cardiac disease, severe thyrotoxicosis, myelomatosis, or anuria, particularly when large doses are administered. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
About MultiHance MultiHance is the highest relaxivity gadolinium-based MRI contrast agent approved for use in the U.S. for MRI of the central nervous system (CNS). MultiHance is also highly stable, with high thermodynamic and conditional stability and no excess chelate.2 The clinical experience with MultiHance exceeds 10 million doses administered worldwide.1
MultiHance is indicated for intravenous use in CNS MRI in adults and children over two years of age, to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues.3 It has approximately twice the relaxivity of other tested gadolinium-based contrast agents approved for CNS MRI in the U.S., providing a marked increase in signal, and in signal-to-noise ratio (SNR).3,4,5
MultiHance, with its higher relaxivity, and higher signal and SNR, has been shown to improve visualization of smaller lesions and delineation of larger lesions of the CNS compared to Magnevist®6 and Omniscan™7 at equivalent doses of 0.1 mmol/kg.4,5
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2 Idée JM, Port C, Raynal I, et al. Clinical and biological consequences of transmetallation induced by contrast agents for magnetic resonance imaging: a review. Fundamental and Clinical Pharmacology. 2006; 20:563-576 3 MultiHance® (gadobenate dimeglumine) injection, 529 mg/mL, Full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc., 2011 4 Maravilla KR et al. Contrast Enhancement of Central Nervous System Lesions: Multicenter Intraindividual Crossover Comparative Study of Two MR Contrast Agents. Radiology 2006; 240: 389-400 5 Rowley HA et al. Contrast-Enhanced MR Imaging of Brain Lesions: a Large-Scale Intraindividual Crossover Comparison of Gadobenate Dimeglumine versus Gadodiamide. Am J Neuoradiology October 2008 29:1684-91 6 MAGNEVIST® (brand of gadopentetate dimeglumine) injection, Full Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2010 7 OMNISCAN™ (gadodiamide) injection, Full Prescribing Information, Princeton, NJ: GE Healthcare Inc.; 2010 Bracco Imaging at RSNA 2011
Lastly, a recent study by Seidl, et al. (n=123) (the MERIT Study, in press at the American Journal of Neuroradiology)8, comparing MultiHance and Gadavist™9 (gadobutrol) injection, a high concentration MRI contrast agent, at equivalent approved doses for CNS MRI, showed that blinded readers reported statistically significant, (p<0.0001), global preference for MultiHance when a preference was expressed. Similar statistically significant preference was demonstrated for each individual endpoint. Reader preference was based on superior contrast enhancement and better delineation of lesion and/or internal lesion structure. In addition, quantitative evaluations of signal intensity (SI), SNR and LBR were
made. The mean percent enhancement of lesions on T1SE images were significantly greater with MultiHance as compared to Gadavist, and statistically significant increases in quantitative enhancement for MultiHance were noted by all three readers for both CNR and LBR. No clinically meaningful differences were noted in adverse events between the two agents.
About ProHance ProHance was the first macrocyclic gadolinium-based MRI contrast agent available for use in the U.S. ProHance was launched in the U.S. market in 1992.
ProHance is indicated for use in MRI in adults and children over two years of age, to visualize lesions with abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. ProHance is also indicated for use in MRI in adults to visualize lesions in the head and neck.10
ProHance has the highest thermodynamic stability constant and conditional stability and the lowest osmolality of the nonionic agents.2
The clinical experience with ProHance exceeds 14 million doses administered worldwide.1
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8 Seidl Z et al. Does Higher Gadolinium Concentration Play a Role in the Morphologic Assessment of Brain Tumors? Results of a Multicenter Intraindividual Crossover Comparison of Gadobutrol versus Gadobenate Dimeglumine (the MERIT Study). AJNR. (In Press) 9 Gadavist™ (gadobutrol) injection, Full Prescribing Information. Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc.; 2010 10 ProHance® (gadoteridol) injection, 279.3 mg/mL, Full Prescribing Information. Princeton, NJ: Bracco Diagnostics Inc.; 2011 Bracco Imaging at RSNA 2011
IMPORTANT SAFETY INFORMATION FOR MULTIHANCE AND PROHANCE
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS
Gadolinium-based contrast agents (GBCAs) increase the risk for NSF among patients with impaired elimination of the drugs. Avoid use of GBCAs in these patients unless the diagnostic information is essential and not available with non-contrasted MRI or other modalities. NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle and internal organs.
• The risk for NSF appears highest among patients with:
2 o chronic, severe kidney disease (GFR <30 mL/min/1.73m ), or acute kidney injury. o • Screen patients for acute kidney injury and other conditions that may reduce renal function. For patients at risk for chronically reduced renal function (e.g. age > 60 years, hypertension or diabetes), estimate the glomerular filtration rate (GFR) through laboratory testing.
• For patients at highest risk for NSF, do not exceed the recommended MultiHance/ProHance dose and allow a sufficient period of time for elimination of the drug from the body prior to re-administration (see WARNINGS).
MultiHance Anaphylactic and anaphylactoid reactions have been reported, involving cardiovascular, respiratory, and/or cutaneous manifestations ranging from mild to severe. The possibility of a reaction should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic disorders.
ProHance As with all paramagnetic agents, caution should be exercised in patients with deoxygenated sickle erythrocytes and renal insufficiency with or without hepatic impairment. The possibility of a reaction, including serious, life threatening, or fatal, anaphylactic or cardiovascular reactions, or other idiosyncratic reactions, should always be considered, especially in those patients with a history of a known clinical hypersensitivity or a history of asthma or other allergic disorders.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For additional information, please visit http://usa.braccoimaging.com/products/imaging- modalities.html. Full Prescribing Information and Instructions for Use for all Bracco products, including the full list of indications, safety information and important boxed warnings where appropriate, is available at Bracco’s RSNA 2011 booth and in its RSNA 2011 press kit. If you have any questions or require additional information about any Bracco product, please contact Bracco Professional Services at 1-800-257-5181, option 2.
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Bracco Imaging at RSNA 2011
About Bracco Imaging Bracco Imaging S.p.A., part of the Bracco Group, is one of the world’s leading companies in the diagnostic imaging business. Headquartered in Milan, Italy, Bracco Imaging develops, manufactures and markets diagnostic imaging agents and solutions that meet medical needs.
Bracco Imaging offers a product and solution portfolio for all key diagnostic imaging modalities: X-Ray Imaging (including Computed Tomography-CT, Interventional Radiology, and Cardiac Catheterization), Magnetic Resonance Imaging (MRI), Contrast Enhanced Ultrasound (CEUS), Nuclear Medicine through radioactive tracers, and Gastrointestinal Endoscopy. The diagnostic imaging offer is completed by several medical devices and advanced administration systems for contrast imaging products in the fields of radiology.
The Company operates in over 90 markets worldwide, either directly or indirectly, through subsidiaries, joint ventures, licenses and distribution partnership agreements. With an on-going research covering all key modalities, Bracco Imaging has a strong presence in key geographies: North America; Europe and Japan operating through the Joint Venture Bracco-Eisai Co., Ltd. The Company also operates in Brazil, South Korea, and China through the Joint Venture Bracco Sine Pharmaceutical Corp. Ltd.
Operational investments have been made in order to achieve top quality and compliance with a sustainable eco-friendly production. Manufacturing activities are located in Italy, Switzerland, Japan, China and Germany.
Bracco Imaging is an innovative Research and Development (R&D) player with an efficient process oriented approach and a track record of innovation in the diagnostic imaging industry. R&D activities are managed in the three Research Centres located in Italy, Switzerland and the USA.
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