Acquisition of Novel MRA Contrast Agent for Peripheral Vascular Imaging Expands Company Product Offerings and Supports Future Growth
N. BILLERICA, Mass. (April 7, 2009) - Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, announced today that it has acquired from EPIX Pharmaceuticals, Inc. (NASDAQ:EPIX) the U.S., Canadian, and Australian rights to MS-325 (formerly marketed as VASOVIST®, gadofosveset trisodium, by Bayer Schering Pharma), a novel magnetic resonance angiography (MRA) agent. In December 2008, EPIX received U.S. Food and Drug Administration marketing approval for MS-325 to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease. Currently, there are no other imaging agents approved for MRA in the U.S.
The acquisition of MS-325 further builds on Lantheus' diagnostic imaging product portfolio and expands the company's presence to the radiology market. Under the terms of the agreement, Lantheus acquired the U.S. (including Puerto Rico), Canadian, and Australian rights to MS-325 from EPIX. EPIX will continue to own European and other ex-U.S. rights for the imaging agent. Lantheus is planning to launch MS-325 under a different name before the year-end.
"The acquisition of MS-325 reinforces our growth strategy to continue to bring to market breakthrough new imaging tools. MS-325 fits well within our current product portfolio of leading contrast imaging agents. As a first-in-class contrast agent, MS-325 provides a true advance in vascular imaging, and may make it possible for physicians to detect peripheral vascular disease differently than X-ray angiography, which is invasive. We are pleased with this important acquisition and look forward to making this diagnostic tool available to physicians to improve diagnosis and patient management," said Don Kiepert, president and CEO of Lantheus Medical Imaging, Inc.
"We are proud to have completed this important transaction with Lantheus Medical Imaging, Inc., a global leader with more than 50 years of experience in the diagnostic imaging space," said Elkan Gamzu, Ph.D., president and CEO of EPIX. "We believe that Lantheus is the ideal company to bring this product to market. Under Lantheus' leadership, MS-325 is well-positioned to become a solid market leader in the field of vascular imaging. Lantheus' commitment to MS-325 also serves as a strong endorsement of the product's diagnostic value in improving the ability to visualize the human vascular system."
MS-325 is an injectable intravascular contrast agent designed to provide improved imaging of the vascular system through magnetic resonance angiography imaging (MRA). MS-325 has been approved for marketing in the United States and in 37 countries outside the United States, including Canada, Australia, all 27 member states of the European Union, Norway, Iceland, Switzerland, Turkey, Korea, Bosnia-Herzegovina, Serbia, and Ukraine. Global marketing rights (outside the U.S., Canada, and Australia) to MS-325 which were held by Bayer Schering Pharma until March 1, 2009 have been transferred to EPIX.
WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)
See full prescribing information for complete boxed warning
Gadolinium-based contrast agents increase the risk of nephrogenic systemic fibrosis (NSF) in patients with:
- acute or chronic severe renal insufficiency (glomerular filtration rate <30 ml/min/1.73m2), or
- acute renal insufficiency of any severity due to the hepato-renal syndrome or in the perioperative liver transplantation period.
In these patients, avoid use of gadolinium-based contrast agents unless the diagnostic information is essential and not available with non-contrast enhanced magnetic resonance angiography (MRA). NSF may result in fatal or debilitating systemic fibrosis affecting the skin, muscle, and internal organs. Screen all patients for renal dysfunction by obtaining a history and/or laboratory tests. When administering a gadolinium-based contrast agent, do not exceed the recommended dose and allow a sufficient period of time for elimination of the agent from the body prior to any re-administration.
Gadofosveset Trisodium injection: As with other contrast media, the possibility of serious or life-threatening anaphylactic or anaphylactoid reactions, including cardiovascular, respiratory and/or cutaneous manifestations, should always be considered. As with other paramagnetic contrast agents, caution should be exercised in patients with renal insufficiency due to the possibility of further deterioration in renal function. In clinical trials, a small increase (2.8 msec) in the average change from baseline in QTc was observed at 45 minutes. These QTc prolongations were not associated with arrhythmias or symptoms. Caution should be used in patients at high risk for QTc prolongation due to QTc prolongation.
About Aortoiliac Occlusive Disease (AIOD) and Peripheral Vascular Disease (PVD)
AIOD occurs when iliac arteries become narrowed or blocked. Arteries are normally smooth and unobstructed on the inside, but with age, plaque can build up in the walls of arteries and cause them to narrow and stiffen. Those affected with AIOD may not receive the blood and oxygen they need throughout their legs, causing pain, sores or gangrene, which can result in the loss of a limb. Peripheral vascular disease (PVD), also known as peripheral arterial disease , refers to diseases of blood vessels outside the heart and brain and includes functional peripheral vascular disease, which doesn't have an organic cause or involve defects in blood vessels' structure and organic peripheral vascular disease, which is caused by structural changes in blood vessels. PVD affects 8 to 12 million people in the U.S.
About Magnetic Resonance Angiography (MRA)
Magnetic resonance angiography uses a powerful magnetic field, radio waves and a computer to produce detailed images of major blood vessels throughout the body. MRA may be performed with or without contrast material and is used in many diagnostic medical procedures including the identification of disease, aneurysms, and atherosclerosis; it is also used to guide surgeons making repairs to diseased blood vessels and plans for surgical operations.
EPIX Pharmaceuticals is a biopharmaceutical company focused on discovering and developing novel therapeutics through the use of its proprietary and highly efficient in silico drug discovery platform. The company has a pipeline of internally-discovered drug candidates currently in clinical development to treat diseases of the central nervous system (see www.trialforAD.com) and lung conditions. EPIX also has collaborations with leading organizations, including GlaxoSmithKline, Amgen and Cystic Fibrosis Foundation Therapeutics.
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.
Lantheus Medical Imaging, Inc.