Lantheus Medical Imaging to Present New Cardiac Imaging Data at The American College of Cardiology 58th Annual Scientific Sessions in Orlando
N.BILLERICA, Mass. (March 25, 2009) – Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced that new data for the company’s echocardiography contrast agent DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension and its novel fluorine 18-labeled Positron Emission Tomography (PET) agent for myocardial perfusion imaging, BMS747158, will be presented in two separate poster presentations at the American College of Cardiology 58th Annual Scientific Session on March 29-31, 2009, in Orlando, Florida.
New data on survival in an intensive care unit population undergoing transthoracic echocardiography with and without perflutren containing ultrasound contrast agents will be presented. The retrospective study includes more than 39,000 propensity matched cases in patients undergoing transthoracic echocardiography with and without contrast agents. The majority of the perflutren cases used DEFINITY®, which is the market-leading product in ultrasound echocardiography contrast agents in the U.S. Additionally, Phase I data regarding the human safety, dosimetry, biodistribution, and myocardial perfusion imaging characteristics under rest and stress conditions of Lantheus’ new PET agent BMS747158 will be presented.
“We look forward to presenting data at the upcoming American College of Cardiology annual meeting,” said Don Kiepert, president and CEO, Lantheus Medical Imaging, Inc. “The new DEFINITY® data expand on findings published in December 2008 that showed that the use of DEFINITY® for enhancing suboptimal resting echocardiography exams was associated with a 26 percent lower risk of mortality when compared with echocardiography performed without a contrast agent. Additionally, the PET agent data further demonstrate Lantheus’ ongoing commitment to developing new agents for the diagnosis and management of cardiovascular disease.”
The schedule, location and abstract information for the poster presentations are as follows:
|Abstract Title:||Survival in an Intensive Care Unit Population Undergoing Transthoracic Echocardiography With and Without Perflutren Containing Ultrasound Contrast Agents: Results in 39,189 Propensity Matched Cases|
|Presentation Time:||Sunday, March 29, 2009, 3:30 p.m. - 4:30 p.m.|
|Presenter:||Michael L. Main M.D., associate professor of medicine, University of Missouri-Kansas City and director, echocardiography laboratory, Saint Luke’s Mid America Heart Institute, Kansas City, Missouri|
|Location:||Orange County Convention Center, West Hall D|
|Abstract Title:||Phase 1 Human Safety, Dosimetry, Biodistribution, and Rest/Stress Myocardial Imaging Characteristics of F-18 Labeled BMS747158|
|Presentation Time:||Tuesday, March 31, 2009, 9:30 a.m. - 10:30 a.m.|
|Presenter:||Jamshid Maddahi, M.D., F.A.C.C., professor of molecular and medical pharmacology (nuclear medicine) and medicine (cardiology) at David Geffen School of Medicine at UCLA|
|Location:||Orange County Convention Center, West Hall D|
Since its launch in 2001, activated DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension has been administered to over two million patients.1 In patients with suboptimal echocardiograms, DEFINITY® enables physicians to visualize the borders of the heart more clearly.2,3
In 2008, Lantheus announced the initiation of CaRES (Contrast Echocardiography REgistry for Safety Surveillance), the first multi-center Phase IV observational registry that will further evaluate the safety profile of DEFINITY® in patients with suboptimal echocardiograms and provide safety information on the use of ultrasound contrast agents in routine clinical practice. The open-label, non-randomized registry is being conducted in more than 10 clinical sites in the United States and will include at least 1,000 patients. The study will gather data on patient characteristics and demographics, indication for DEFINITYÒ’s use, results of safety monitoring of patients during and after DEFINITY® administration, and the nature and frequency of any adverse events that may occur.
Activated DEFINITY® (Perflutren Lipid Microsphere) Injectable Suspension is indicated for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. The safety and efficacy of DEFINITY® with exercise stress or pharmacologic stress testing have not been established. For full prescribing information, please visit www.lantheus.com.
Important Safety Information About DEFINITY®
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.
Do not administer DEFINITY® to patients with known or suspected cardiac shunts (right-to-left, bi-directional or transient right-to-left), or hypersensitivity to perflutren. Do not administer DEFINITY® by intra-arterial injection.
In postmarketing use, uncommon but serious reactions observed during or shortly following perflutren-containing microsphere administration included fatal cardiac or respiratory arrest, loss of consciousness, convulsions, symptomatic arrhythmias (atrial fibrillation, supraventricular tachycardia, ventricular tachycardia or fibrillation), hypotension, respiratory distress or cardiac ischemia (see ADVERSE REACTIONS). The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, serious ventricular arrhythmias or respiratory failure, including patients receiving mechanical ventilation). In the absence of these underlying conditions, observe patients closely during and following DEFINITY® administration.
Always have cardiopulmonary resuscitation personnel and equipment readily available prior to DEFINITY® administration and monitor all patients for acute reactions.
BMS747158 is a fluorine 18-labeled agent that binds to the mitochondrial complex 1 (MC-1) inhibitor and was designed to be a novel myocardial perfusion PET imaging agent.
Preclinical studies have demonstrated the unique potential of BMS747158 to serve as a new class of PET agent for myocardial perfusion imaging. The agent demonstrates high, rapid and sustained cardiac uptake which is proportional to myocardial perfusion over a wide range of blood flow rates. The agent also exhibits high target to non-target uptake ratios, perfusion defect recognition, and very high image quality in multiple species.
About Lantheus Medical Imaging, Inc.Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medicine for the past 50 years, is committed to advancing the field of diagnostic imaging. The company’s proven success in discovering, developing and marketing innovative medical imaging agents provides an unparalleled platform from which to bring forward breakthrough new tools for the diagnosis and management of disease. The company is home to leading diagnostic imaging brands, including Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, and TechneLite® (Technetium Tc99m Generator) and has nearly 700 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada, and Australia. For more information, visit www.lantheus.com.
1 Source: The Echocardiography Monthly Monitor: United States, October 2001-September 2007, Arlington Medical Resources, Inc., Malvern, PA.
2 Kitzman DW et al. Efficacy and safety of the novel ultrasound contrast agent perflutren (definity) in patients with suboptimal baseline left ventricular echocardiographic images. AM J Cardiol. 2000; 86: 669-674.
3 Data on file, Lantheus Medical Imaging, Inc.