Bracco Diagnostics' MultiHance Earns FDA Approval; MRI Imaging Agent Designed for Higher Relaxivity, Enhanced Image Resolution.

PRINCETON, N.J. -- Bracco Diagnostics Inc. today announced that it has received approval from the United States Food & Drug Administration (FDA) to market MultiHance(R) (gadobenate dimeglumine) injection, 529 mg/ml, a gadolinium-based contrast agent for Magnetic Resonance Imaging (MRI). FDA approval of MultiHance expands Bracco Diagnostics' product portfolio within the United States, which includes many leading diagnostic imaging contrast agents.

MultiHance(R) is indicated for use in MRI of the central nervous system in adults to visualize lesions with abnormal blood brain barrier or abnormal vascularity of the brain, spine and associated tissues. Unlike other paramagnetic contrast agents, this new agent demonstrates a strong increase in relaxivity in any solution containing serum proteins. This results in greater signal intensity enhancement, which may contribute to improved visualization.

Results of clinical trials, including double-blind multicenter trials in adults highly suspected of having brain or spine lesions, showed that MultiHance significantly improved lesion detection, as well as the degree of lesion border delineation, the degree of visualization of lesion internal morphology, and the degree of lesion contrast enhancement.

Mrs. Diana Bracco, Chairman and CEO of Bracco Group, commented: "This is a remarkably important result for Bracco in an extremely advanced high-tech field. The approval of MultiHance in the USA is also an acknowledgment of Bracco 's competitive edge in a demanding market place."

Bracco Diagnostics' President and Chief Executive Officer Carlo Medici hailed the FDA's approval of MultiHance as a major benchmark for Bracco, and ultimately a diagnostic advance that will benefit physicians and their patients. "FDA approval of MultiHance advances the entire imaging portfolio for Bracco Diagnostics, and further underscores our commitment to innovation and to bringing to market better contrast agents to meet the evolving needs of physicians and diagnostic imaging professionals," said Medici.

MultiHance was previously approved for use in Europe and other regions of the world. It has been used in over 1,000,000 patient exams worldwide.

About Bracco

The Bracco Group is a world-leading provider of global diagnostic imaging solutions, with net sales of more than $1.25 billion. Bracco has operations in 115 countries and about 3,500 employees, over 600 of whom work in R&D. Bracco invests approximately 15% of its annual turnover in R&D and has a portfolio of 1,500 patents worldwide.

The Bracco Group is a leader in the diagnostic imaging market with an integrated product offering from a diverse roster of subsidiary companies. While Bracco is recognized internationally as a definitive market leader in its core business of contrast media, Bracco also markets key diagnostic imaging resources through the following companies: Esaote, which is one of the world's primary producers of magnetic resonance and ultrasonographic medical equipment; ACIST Medical Systems, a leading U.S. producer of advanced contrast media injection systems; EBIT-AET, which creates and markets medical application software; and Singapore-based Volume Interactions, which also produces advanced medical software.

Bracco also operates a high-level international research network, with three centers (Milan, Geneva, and Princeton). These centers develop products for the latest-generation diagnostic techniques, from X-ray and computed tomography (CT) to magnetic resonance imaging (MRI), nuclear medicine and ultrasound.

About MultiHance

As with all paramagnetic agents, caution should be exercised in patients with deoxygenated sickle erythocytes.

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 known clinical hypersensitivity or a history of asthma or allergic respiratory disorders.