June 24, 2008 FDA Advisory Meeting

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Presentation transcript:

June 24, 2008 FDA Advisory Meeting Maurizio Denaro MD Vice President Bracco Group R&D and Head of Ultrasound Business Unit

SonoVue® Composition and Structure Sulfur hexafluoride (SF6) microbubbles Envelope/shell: Lipid/Phospholipids Microbubble diameter (Dn) 1.5 – 2.5 µm Human imaging dose 2 – 2.4 mL of microbubble suspension (0.03 mL/kg) in saline Volume of gas per human dose is 16-20 µL Catena idrofobica Phospholipid SF6

SonoVue: Marketed in 21 Countries European Union Switzerland Norway Iceland China Hong Kong South Korea Singapore

SonoVue: Approved Indications Echocardiography … for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers and enhance left ventricular endocardial border delineation Microvascular enhacement …SonoVue® improves visualization of liver and breast lesion vascularity during Doppler Sonography, leading to more specific lesion characterization Macrovascular enhancement … increases the accuracy in detection or exclusion of abnormalities in cerebral arteries and extra-cranial carotid or peripheral arteries by improving the Doppler signal-to-noise ratio.

Ultrasound Contrast Agents : Unique Characteristics SonoVue is a pure blood pool agent that provides real-time information of the vasculature improves the diagnostic information from MACROcirculation has an unique role in providing information of the MICROcirculation (vessels diameter below 200 m) useful for tissue organ perfusion characterization

Dr R. Senior, MD, DM, FRCP, FESC, FACC Bracco Experts Dr R. Senior, MD, DM, FRCP, FESC, FACC Consultant Cardiologist and Director of Cardiac Research, Department of Cardiovascular Medicine, Northwick Park Hospital, Harrow, Middlesex, UK Patricia D. Williams, Ph.D. Chief Operating Officer Summit Drug Development Services, LLC Rockville, MD, USA

SonoVue: Key Messages Established safety record Highly positive risk/benefit profile in the approved indications Among the rare serious ADRs (RR 0.014%) the most frequent are allergy-like reactions (RR 0.01%) Nonclinical tools have been identified which may help to profile new agents to reduce potential risks