FDA Approves Dotarem® (gadoterate meglumine), First Macrocyclic and Ionic Gadolinium-based Contrast Agent in USA

VILLEPINTE, France, March 27, 2013 /PRNewswire/ --

Guerbet announced today that the US Food and Drug Administration (FDA) has approved Dotarem® (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

Dotarem® -- which has been commercialized widely throughout the world since 1989 and more than 37 million doses administered^[1] -- is the only macrocyclic and ionic GBCA. The recommended dose is 0.2 mL/kg (0.1 mmol/kg) body weight (BW). Dotarem® Injection 0.5 mmol/mL contains 376.9 mg/mL of gadoterate meglumine, and is available in vials and pre-filled syringes.

"This approval is a major milestone for Guerbet, which has a proud history of providing safe and effective contrast agents to patients worldwide," said Yves L'Epine, CEO of Guerbet Group. "Dotarem® - already a leader in Europe - is a compelling new CNS imaging option for US healthcare providers and enriches our portfolio for improved patient management with diagnostic imaging in the US."

MRI has become the mainstay of central nervous system imaging since its introduction over 20 years ago. It is estimated that there were more than 10 million contrast-enhanced MRI examinations performed in the US in 2011, with approximately 60% of these examinations performed to image the CNS.

Important security information

In compliance with recommendations issued by national, European (EMA) and US (FDA) drug safety agencies, product leaflets and prescribing information for gadolinium-based contrast products contain information on the risks of nephrogenic systemic fibrosis (FSN).

For further information on Dotarem®, and notably full safety information, refer to the summary of the product characteristics in force in your country.

Clinical Studies

The Dotarem® New Drug Application included two Phase III clinical studies. These studies evaluated the diagnostic efficacy and safety of Dotarem® for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (2 years of age and older) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity. Both phase III studies evaluated the superiority of the enhanced images over the unenhanced images for central nervous system (CNS) lesion visualization in all three co-primary endpoints. All defined primary and key secondary efficacy analyses were met and support the efficacy of Dotarem® at a standard dose of 0.1 mmol/kg BW. In addition to these two studies, 21 supportive clinical studies evaluated the efficacy and safety of Dotarem®-enhanced MRI.

About Dotarem®

Commercialized widely in over 70 countries in Europe, Asia, Africa, Middle East and South America, more than 37 million doses of Dotarem® have been administered. The approved indications for Dotarem® may vary between countries. Dotarem® is the leading contrast agent in Europe with 47% market share in 2012^[2].

About Guerbet

A pioneer in the field of contrast agents with more than 80 years of experience, Guerbet is the only pharmaceutical group fully dedicated to medical imaging worldwide. As such it has a complete offering of contrast products for Xray and MRI and for interventional radiology, along with a range of injectors and related medical equipment to provide improved diagnosis and treatment of patients.

To promote the discovery of new products and assure future growth, Guerbet devotes significant resources to research and development every year (approximately 10% of sales). Guerbet (GBT) is listed on NYSE Euronext Paris (Eurolist Segment B - Mid Caps) and had sales of €403 million in 2012 with a total workforce of 1,400 employees. Guerbet also markets Hexabrix®, Oxilan®, and Lipiodol® contrast agents in the US.

This press release may contain forward-looking statements based on current assumptions and forecasts made by Guerbet Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performances of the company and the estimates given here. These factors include those discussed in Guerbet's public reports which are available on the Guerbet website at  http://www.guerbet.com. The company assumes no liability whatsoever to update these forward-looking-statements or to conform them to future events or developments.

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1. Data of file as of January 1, 2013.

2. In MRI, in volume. ECMIG 2011.

Dotarem® is registered in U.S. Patent and Trademark Office by Guerbet.