Lantheus Medical Imaging, Inc. Launches DEFINITY® Ultrasound Contrast Imaging Agent in India
-- Company Expands Global Presence and Access to DEFINITY®
With Distributor J.B. Chemicals & Pharmaceuticals, Ltd. --
N. BILLERICA, Mass. (July 15, 2010) – Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced the launch of its ultrasound contrast imaging agent, DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, in India. The company has signed a multi-year agreement with Mumbai-based J.B. Chemicals & Pharmaceuticals, Ltd. (“JBCPL”) for the distribution and marketing of DEFINITY® in the Indian marketplace. The launch expands Lantheus’ presence in southern Asia. DEFINITY® is currently marketed in North America, Australia and New Zealand, parts of the Pacific Rim, and several countries in the Middle East.
DEFINITY® is an ultrasound contrast imaging agent that is indicated in India for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, as well as for use in patients in contrast-enhanced diagnostic ultrasound imaging to improve characterization of focal lesions of the liver and kidney.
“The introduction of DEFINITY® in India reinforces the important role this diagnostic imaging agent can play in helping physicians across the globe make informed decisions about patient treatment and care, ” said Cyrille Villeneuve, Vice President and General Manager, International, at Lantheus Medical Imaging, Inc. “Accessing the Indian market is part of our global expansion strategy for DEFINITY®, and this agreement with JBCPL, a leading Indian supplier of pharmaceuticals and diagnostic imaging products, provides Lantheus with a great opportunity to sell product in this important geographic region. JBCPL has a strong marketing infrastructure and an extensive sales force, and we believe that they are the ideal partner to sell and distribute DEFINITY® in India.”“We are proud to partner with Lantheus Medical Imaging to launch DEFINITY® in India,” said Mr. Pranabh Mody, President, J.B. Chemicals & Pharmaceuticals, Ltd. “DEFINITY® is a strategic fit for JBCPL and its addition to our product portfolio underscores our strength and continued commitment to the diagnostic medical imaging market.”
DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal cardiograms (see Indications below)1,2. In India, the product is also indicated for use in patients to improve the characterization of focal lesions of the liver and kidney. Since its launch in 2001, activated DEFINITY® has been administered to more than 2.5 million patients in the United States3. Because up to 20 percent of resting echocardiography studies will result in suboptimal echocardiograms4,5,6the use of a contrast agent may reduce the need for subsequent testing7.
INDICATIONS in the United States
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.
CONTRAINDICATIONS in the United States
Do not administer DEFINITY® to patients with known or suspected right-to-left, bi-directional or transient right-to-left cardiac shunts, by intra-arterial injection, or to patients with known hypersensitivity to perflutren.
IMPORTANT SAFETY INFORMATION
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.
WARNING: Serious Cardiopulmonary Reactions
In post marketing use, rare but serious cardiopulmonary or anaphylactoid reactions have been reported during or shortly following perflutren-containing microsphere administration (see ADVERSE REACTIONS). The risk for these reactions may be increased among patients with pulmonary hypertension or unstable cardiopulmonary conditions. It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.
About Lantheus Medical Imaging, Inc.
J.B. Chemical & Pharmaceutical, Ltd. has been in the pharmaceuticals business for more than 35 years and deals in pharmaceutical formulations, active pharmaceutical ingredients and contrast media products. Its group revenues last year were more than $165 million USD with about 65 percent revenues from exports to regions such as Russia, Ukraine, the CIS countries, South-East Asia, South Africa, other African countries, Asian Countries, etc. This quality-centric company has a wide distributor network in India and abroad, and has ambitious business plans for growth in the Contrast Media Products business. JBCPL is a publicly traded Indian company. It has its own manufacturing facilities and employs about 3,000 people worldwide. For more details about JBCPL, one can log on to www.jbcpl.com.
Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medicine for more than 50 years, is dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The company’s proven success in discovering, developing and marketing innovative medical imaging agents provides a strong platform from which to bring forward breakthrough new tools for the diagnosis and management of disease. Lantheus imaging products include the echocardiography contrast agent DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, ABLAVAR® (gadofosveset trisodium), a first-in-class magnetic resonance agent indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease, TechneLite® (Technetium Tc99m Generator), Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), and Thallium 201 (Thallous Chloride Tl 201 Injection). Lantheus has more than 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Canada, Puerto Rico, and Australia. For more information, visit www.lantheus.com.
1. 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.
2. Data on file, Lantheus Medical Imaging, Inc.
3. The Echocardiography Monthly Monitor: U.S. Editions, 2002 - 2009, Arlington Medical Resources, Inc., Malvern, PA.
4. Mulvagh SL et al. Contrast Echocardiography: Current and future applications. J Am Soc Echocardiogr 2000; 13:331-42.
5. Waggoner AD, et al, Guidelines for the cardiac sonographer in the performance of contrast echocardiography. J Am Soc Echocardiogr. 2001: 417-420.
6. Solomon, SD, Ed. Essential Echocardiography, A Practical handbook with DVD. Humana Press; 2007 Chapter 5: Ventricular Systolic Function, p113.
7. Shaw LJ et al. Clinical and economic outcomes assessment with myocardial contrast echocardiography. Heart. 1999; 82(Suppl III): III16-III21.