Healthcare Industry News: gadofosveset
News Release - January 21, 2011
Lantheus Medical Imaging Announces New National Contract with Novation for ABLAVAR(R) and DEFINITY(R)Distribution Agreement Expands Access to Novel Diagnostic Imaging Agents for Health Care Providers Served by Novation
NORTH BILLERICA, Mass.--(Healthcare Sales & Marketing Network)-- Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, today announced a national contract with Novation for ABLAVAR® (gadofosveset trisodium) and DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension, providing increased access to these important diagnostic imaging agents for health care providers served by Novation. Novation is the leading health care supply contracting company for more than 25,000 members of VHA Inc. and the University HealthSystem Consortium (UHC), two health care alliances, and 5,500 members of Provista, LLC, representing 28,000 sites.
“We are pleased to announce this agreement with one of the nation’s largest group purchasing organizations for the distribution of ABLAVAR® and DEFINITY®,” said Robert Spurr, Vice President, Sales and Marketing at Lantheus Medical Imaging. “Novation can now offer the members they serve access to the clinical benefits of these valuable contrast imaging agents. ABLAVAR® is a novel magnetic resonance angiography (MRA) blood pool imaging agent indicated for evaluation of aortoiliac disease (AIOD) in adults with known or suspected peripheral vascular disease, while DEFINITY® is used in patients with suboptimal echocardiograms to opacify the left ventrical chamber and to improve the delineation of the left ventricular endocardial border.”
Diagnostic imaging agents like ABLAVAR® and DEFINITY® can help physicians in the diagnosis and treatment of disease. These agents are used to improve image quality. ABLAVAR® makes it possible for physicians to detect vascular disease using MRA, which is less invasive than conventional X-ray angiography, the current standard of care, and without exposing patients to ionizing radiation. DEFINITY® is used to improve image quality in patients with suboptimal echocardiograms.
About ABLAVAR® (gadofosveset trisodium)
ABLAVAR® is the first and only blood pool contrast agent approved for magnetic resonance angiography to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral 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. ABLAVAR® 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 such as AIOD. gadofosveset trisodium has been used in nearly 90,000 patients to date3. Lantheus acquired exclusive rights for ABLAVAR® in the United States, Canada and Australia in April 2009, and the product was launched 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.
ABLAVAR® 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.
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.
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, including boxed WARNING regarding Nephrogenic Systemic Fibrosis (NSF), at www.ablavar.com.
DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal cardiograms (see Indications below)4. DEFINITY® is the leading cardiac ultrasound contrast agent in the United States. Approximately 25 million echocardiograms are performed in the U.S. each year5. Since its launch in 2001, activated DEFINITY® has been administered to more than 2.6 million patients6.
Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions, at www.definityimaging.com.
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.
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 about DEFINITY®:
WARNING: Serious Cardiopulmonary Reactions
Serious cardiopulmonary reactions, including fatalities, have occurred during or following perflutren-containing microsphere administration.
- Assess all patients for the presence of any condition that precludes DEFINITY® administration (see CONTRAINDICATIONS).
- In patients with pulmonary hypertension or unstable cardiopulmonary conditions, monitor vital sign measurements, electrocardiography and cutaneous oxygen saturation during and for at least 30 minutes after DEFINITY® administration (see WARNINGS).
- Always have resuscitation equipment and trained personnel readily available.
Founded in 1998, Novation is the leading health care supply contracting company for more than 25,000 members of VHA Inc. and the University HealthSystem Consortium (UHC), two health care alliances, and 5,500 members of Provista, LLC, representing 28,000 sites. Novation provides alliance members contract and price management and spend management services. Based in Irving, TX, Novation develops and manages competitive contracts with more than 600 suppliers. VHA, UHC and Provista members used Novation contracts to purchase nearly $37.8 billion in 2009. For more information, visit www.novationco.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 650 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia. For more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the agreement with Novation. Such forward-looking statements are subject to risks and uncertainties, including, but not limited to, statements related to the agreement with Novation and other factors that may be described from time to time in our filings with the Securities and Exchange Commission. Readers are cautioned not to place undue reliance on these forward-looking statements contained herein, which speak only as of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
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.
4 DEFINITY® (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc., 2009.
5 The Echocardiography Market Guide, U.S. Editions, 2001 – 2009. ©Arlington Medical Resources, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited.
6 The Echocardiography Monthly Monitor: U.S. Editions, 2001 – June 2010. ©Arlington Medical Resources, Inc. All rights reserved. Reproduction, distribution, transmission or publication is prohibited.
Source: Lantheus Medical Imaging
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