Guerbet Offers Comprehensive Solution to Contrast Media Needs

Since 1901 Guerbet Group has had a long-standing tradition as a pioneer in the research and development of medical imaging contrast media. Headquartered in Paris, France, Guerbet is a publicly traded company holding more than 25% of the European market share and 7% of the worldwide contrast media market.

The Guerbet product portfolio is marketed in 130 countries worldwide and contains contrast agents for X-ray and MRI modalities: Oxilan^®, Hexabrix^®(1), Dotarem^®(2), Lumirem^®(2), Endorem^®(2) and others. Guerbet dedicates the best talent and resources to new drug development, currently having multiple agents in Phase III clinical trials.

Guerbet LLC, the U.S. subsidiary, was established in January of 2002 by purchasing the assets of Oxilan^® from Cook, one of the leaders in the medical device industry.

Currently Guerbet LLC is responsible for the marketing, sales and distribution of Oxilan^® (ioxilan) Injection, a non-ionic contrast medium for diagnostic and interventional procedures, and Hexabrix^® (sodium and meglumine ioxaglate), a low-osmolar ionic contrast medium for interventional cardiac procedures. In addition, steps are underway to seek approval for new products in the U.S. market.

Hexabrix® NDA Transferred to Guerbet
BLOOMINGTON, Ind. - Guerbet recently announced that it has completed the NDA transfer for Hexabrix®, a premium low-osmolar, ionic contrast media product developed by Guerbet in 1985. With this transfer, Guerbet brings Hexabrix®, one of the most researched contrast media agents available, into its U.S. subsidiary's product portfolio.

"Bringing Hexabrix® back into the Guerbet family of products allows us to strengthen our foothold in the most important diagnosis market in the world. With the most complete range of X-ray and MRI contrast media products worldwide, we expect continued growth from our U.S. arm," said Philippe Decazes, Guerbet's chairman of the executive board and chief executive officer.

Guerbet developed Hexabrix® and licensed it for distribution in the United States through Covidien (formerly Mallinckrodt). Current Hexabrix® customers can expect a seamless transition; and Guerbet will continue to work with long-time partner Covidien to co-market the product.

Hexabrix® is used in a variety of radiographic procedures, including pediatric angiography, selective coronary arteriography with or without left ventriculography, peripheral arteriography, aortography, selective visceral arteriography, cerebral angiography, intra-arterial digital substraction angiography, intravenous digital substraction angiography, peripheral venography (phlebography), excretory urography, contrast enchancement of computer tomographic head and body imaging, arthrography, and hysterosalpinography.

Oxilan^® Receives Frost & Sullivan North American Product Quality Award
Frost & Sullivan selected Guerbet as the recipient of the 2007 North American Frost & Sullivan Product Quality Leadership Award for the superiority of its contrast media products.

The company is renowned for its high product quality, especially of Oxilan® (ioxilan) Injection, its non-ionic low viscous and low osmolar monomer X-ray contrast agent.

"Contrast media products in the medical imaging industry encounter several technical and regulatory hurdles, developmental costs, clinical testing, and FDA approval to reach a sellable stage and finally, gain acceptance by end users," says Frost & Sullivan Research Analyst AJ Ajibade. 

"Guerbet has implemented a product development strategy that emphasizes quality and customer satisfaction, with the high quality technical characteristics of its contrast media products embodying the extent of its commitment."Guerbet has Oxilan to thank for its sustained success.  Despite the possibility of side effects in injection of X-ray contrast media, Oxilan has achieved remarkably positive usage feedback, confirming it to be a safe product.

Based on differences in structure, ionicity, osmolality and viscosity, contrast media are categorized under either monomers or dimers, ionic or non-ionic, low osmolar contrast media (LOCM) or high osmolar contrast media (HOCM) and low viscous contrast media (LVCM) or high viscous contrast media (HVCM).  As an LOCM and LVCM, Oxilan shows fewer adverse side effects and is the contrast media of choice for diagnostic and interventional radiology and cardiology applications.

Apart from its efficacy, Oxilan also ensures accurate diagnosis.  Guerbet is aware of the significance of ionicity, chemical structure, osmolality, and viscosity in influencing the quality of contrast media, especially while considering the visualization, hemodynamics, thrombogenicity, contrast-induced nephropathy, and other various clinical outcomes.  They implemented this knowledge in the development of Oxilan to create a solution that offers first-rate imaging with minimal side effects.

"Oxilan's unique molecular structure has a hydrophobic region within its hydrophilic side chain, which leads to molecular aggregation and a reduction in the number of osmotically active particles in solution," explains Ajibade.  "This results in the lowest osmolality (695mOsm/kg H2O) and viscosity (16.3 mPa.s at 20°C) of all non-ionic monomer contrast media."

Guerbet continues to take advantage of its rich market experience in Europe and worldwide.  They have developed a variety of X-ray and MR contrast agents to help provide quality products, which enables improved patient management through effective diagnosis.

Oxilan's technical specifications and consequent product quality are invaluable benefits to the contrast media industry, a characteristic meticulously engineered by Guerbet.

Each year, Frost & Sullivan presents this Award to the company that has demonstrated superior quality control over their existing competitors in product manufacturing.  Quality control is an essential element of customer satisfaction and it encourages repeat business, assuring long-term market survival.  "Guerbet's opportunity to improve disease management and impact patient care is through the commercialization of high quality, innovative contrast agents.  Receiving this prestigious award from well recognized Frost and Sullivan validates that Guerbet is continuing to deliver on this mission to physicians and patients," says Guerbet General Manager for USA subsidiary Amy Lutes.

Frost & Sullivan Best Practices Awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research in order to identify best practices in the industry.

Oxilan - Indications & Safety Information
NOT FOR INTRATHECAL USE

Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use.  These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.  Special attention must be given to ensure that this drug product is not administered intrathecally.

Nonionic iodinated contrast media inhibit blood coagulation, in vitro, less than ionic contrast media.  The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiocardiographic procedures with both ionic and nonionic contrast media.  Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events.  Please see full prescribing information at www.guerbet-us.com.

Hexabrix - Indications & Safety Information
NOT FOR INTRATHECAL USE

Ionic iodinated contrast media inhibit blood coagulation, in vitro, more than nonionic contrast media.

Hexabrix is contraindicated for use in myelography.

Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use.  These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.  Special attention must be given to ensure that this drug product is not administered intrathecally.

Severe, life threatening anaphylactoid reactions, mostly of the cardiovascular origin, have occurred following the administration of Hexabrix as well as other iodine containing contrast agents.  The most frequent adverse reactions are nausea, vomiting, facial flush and a feeling of body warmth.  These are usually of brief duration.  In double-blind clinical trials, Hexabrix produced less discomfort upon injection (pain and heat) when compared to various other contrast agents.  Please see full prescribing information at www.guerbet-us.com.

Contact details:
Melissa Buchanan
Brand Manager
T: 812-333-0059
E: melissa.buchanan@guerbet-group.com