Lantheus Medical Imaging, Inc. Launches ABLAVAR® in Canada

Company Advances International Growth Strategy and Expands Access to Novel Magnetic Resonance Angiography Blood Pool Agent in North America

N. BILLERICA, Mass.--()--Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced the Canadian launch of ABLAVAR® (gadofosveset trisodium injection), a unique, injectable magnetic resonance angiography (MRA) blood pool imaging agent. This launch is part of Lantheus’ corporate growth strategy to expand the company’s presence and product offerings in key international markets and to increase access to medically important diagnostic imaging agents. In Canada, ABLAVAR® was previously marketed as Vasovist® and is indicated for contrast-enhanced MRA for visualization of abdominal or limb vessels in patients with suspected or known vascular disease. Lantheus launched ABLAVAR® in the United States earlier this year where it is indicated for the evaluation of aortoiliac occlusive disease in adults with known or suspected peripheral vascular disease. The company recently announced the acquisition of the worldwide rights for this novel product.

“ABLAVAR® is a welcome addition to the tools we currently have available in Canada for the evaluation of vascular disease, as it is specifically designed for use with MRA and allows for both first-pass imaging as well as steady-state imaging, which can provide additional information of the vasculature,” said Josephine Pressacco, M.D., Ph.D., Montreal Heart Institute. “The albumin-binding properties of this product allow us to obtain bright, high resolution images with a single low dose, which may reduce the need for additional or repeat testing for patients.”

“We are pleased that the introduction of ABLAVAR® in Canada can provide patients and physicians in this important geographic region with a unique MRA imaging agent to diagnose and evaluate vascular disease,” said Cyrille Villeneuve, Vice President and General Manager, International, Lantheus Medical Imaging, Inc. “Launching ABLAVAR® in Canada is part of our ongoing strategy to provide increased access to innovative medical diagnostic imaging tools and to expand the presence of Lantheus globally.”

Blood pool agents remain in the vasculature for an extended period of time, increasing the brightness of blood in a magnetic resonance diagnostic procedure, resulting in high-resolution images. The albumin-binding properties of ABLAVAR® make it uniquely designed for vascular imaging because it provides an expanded imaging window, making it possible to evaluate not only the location of disease but the extent and severity of disease.

About Magnetic Resonance Angiography

Magnetic resonance angiography (MRA) is a specific type of magnetic resonance imaging (MRI) procedure that provides pictures of blood vessels. MRA can show the blockage of the flow of blood to areas of the body such as the brain, kidneys and legs.

About ABLAVAR® (gadofosveset trisodium injection and gadofosveset trisodium)

ABLAVAR® (gadofosveset trisodium injection) is clinically proven to produce high resolution MRA images, combining both dynamic (first pass) and steady state imaging, resulting in diagnostic accuracy comparable to conventional X-ray angiography1,2, the current standard of care for diagnosing vascular disease. The albumin-binding properties of ABLAVAR® make it uniquely designed for vascular imaging, allowing multiple images to be obtained using a single, low dose injection. In Canada, ABLAVAR® is indicated for contrast-enhanced magnetic resonance angiography (MRA) for visualization of abdominal or limb vessels in patients with suspected or known vascular disease. Gadofosveset trisodium has been used in over 90,000 patients to date3. The compound was formerly marketed as Vasovist® outside the United States. Lantheus acquired exclusive rights for ABLAVAR® in the United States, Canada and Australia in April 2009 and launched the product in the United States in January 2010. The company announced the purchase of the balance of the worldwide rights for the product in July 2010.

INDICATIONS in the United States:

ABLAVAR® (gadofosveset trisodium) is indicated for use as a contrast agent in magnetic resonance angiography (MRA) to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease.

CONTRAINDICATIONS in the United States:

History of a prior allergic reaction to a gadolinium-based contrast agent.

Important Safety Information About ABLAVAR®:

WARNING: NEPHROGENIC SYSTEMIC FIBROSIS (NSF)


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 imaging (MRI). 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.

ABLAVAR® 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 arrhythmias due to baseline QTc prolongation.

Have emergency resuscitative equipment available prior to and during ABLAVAR® administration.

Please see full Prescribing Information for the United States, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF), at www.ablavar.com.

About Lantheus Medical Imaging, Inc.

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 Puerto Rico, Canada and Australia. For more information, visit www.lantheus.com.

1 Goyen, M, Edelman, M, Perreault, P, et al. MR Angiography of Aortoiliac Occlusive Disease: A Phase III Study of the Safety and Effectiveness of the Blood-Pool Contrast Agent MS-325. Radiology. 2005; 236(3):825-833.

2 Rapp, JH, Wolff, SD, Quinn, SF, et al. Aortoiliac Occlusive Disease in Patients with Known or Suspected Peripheral Vascular Disease: Safety and Efficacy of Gadofosveset-Enhanced Angiography – Multicenter Comparative Phase III Study. Radiology. 2005; 236(1):71-78.

3 Data on File, Lantheus Medical Imaging, Inc.

Contacts

Pure Communications, Inc.
Kelly Hennessy, 617-227-0552, Cell: 617-699-5684

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Contacts

Pure Communications, Inc.
Kelly Hennessy, 617-227-0552, Cell: 617-699-5684