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Lantheus Medical Imaging Awarded Three-Year Supplier Agreements with the Premier Healthcare Alliance for Ultrasound Contrast Agent DEFINITY® and Magnetic Resonance Angiography Imaging Agent ABLAVAR®

Tue, 10/25/2011 - 5:49am

NO. BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, today announced it has been awarded three-year supplier contracts with Premier Purchasing Partners, L.P., the group purchasing unit of the Premier healthcare alliance, in the category of cardiac ultrasound contrast media for its ultrasound contrast agent, DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension, and its magnetic resonance angiography (MRA) blood pool imaging agent, ABLAVAR® (gadofosveset trisodium).

The cardiac ultrasound contrast media contract award is a three-year sole-source supplier agreement, effective December 1, 2011 through November 30, 2014. The ABLAVAR® contract award is a three-year supplier agreement, effective January 1, 2012 through December 31, 2014. These new agreements allow Premier members, at their discretion, to take advantage of special pricing and terms pre-negotiated by Premier for DEFINITY® and ABLAVAR®.

DEFINITY®, an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border cardiograms1, and ABLAVAR®, an MRA contrast agent indicated to evaluate aortoiliac occlusive disease (AIOD) in adults with known or suspected peripheral vascular disease (PVD)2-8, will both be offered to more than 2,500 hospitals nationwide and 76,000-plus healthcare sites. The contracts were awarded after a competitive bidding process that examined multiple factors, including pricing and clinical experience with DEFINITY® and ABLAVAR®, as well as Lantheus support of the products.

"We are pleased that Premier has awarded Lantheus with a three-year sole-source supplier agreement for DEFINITY® and a three-year agreement to offer its members ABLAVAR®," said Don Kiepert, President and Chief Executive Officer, Lantheus Medical Imaging. "These products are innovative diagnostic tools that assist clinicians in the diagnosis of cardiovascular diseases and help answer critical clinical questions to make improved patient management decisions. We look forward to continuing our long-standing relationship with Premier and providing member physicians with access to these important imaging agents."

About DEFINITY® Vial for (Perflutren Lipid Microsphere) Injectable Suspension

DEFINITY® Vial For (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal cardiograms)1. Since its launch in 2001, activated DEFINITY® has been administered to more than three million patients9.

INDICATIONS

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.

CONTRAINDICATIONS

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

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.

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.

Please see accompanying full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions, at www.definityimaging.com.

About ABLAVAR® (gadofosveset trisodium injection and gadofosveset trisodium)

ABLAVAR® (gadofosveset trisodium injection) is clinically proven to produce high resolution magnetic resonance angiography (MRA) images, combining both dynamic (first pass) and steady state imaging, resulting in diagnostic accuracy comparable to conventional X-ray angiography10,11, 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. Gadofosveset trisodium has been used in approximately 100,000 patients to date12.

INDICATIONS :

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:

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 global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, is dedicated to creating and providing pioneering medical imaging solutions to improve the treatment of human disease. The Companys proven success in the field of diagnostic imaging 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, an ultrasound contrast agent for use in patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border, 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 approximately 600 employees worldwide with headquarters in North Billerica, Massachusetts, and offices in Puerto Rico, Canada and Australia. For more information, visit www.lantheus.com.

About the Premier Healthcare Alliance, Malcolm Baldrige National Quality Award Recipient

Premier is a performance improvement alliance of more than 2,500 U.S. hospitals and 76,000-plus other healthcare sites using the power of collaboration to lead the transformation to high quality, cost-effective care. Owned by hospitals, health systems and other providers, Premier maintains the nation's most comprehensive repository of clinical, financial and outcomes information and operates a leading healthcare purchasing network. A world leader in helping deliver measurable improvements in care, Premier has worked with the Centers for Medicare & Medicaid Services and the United Kingdom's National Health Service North West to improve hospital performance. Headquartered in Charlotte, N.C., Premier also has an office in Washington.

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. Such forward-looking statements are subject to risks and uncertainties 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 the forward-looking statements contained herein, which speak only as of the date hereof. 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 DEFINITY® (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc., 2009.

2 ABLAVAR® (Package Insert). North Billerica, MA: Lantheus Medical Imaging, Inc. 2011.

3 Magnevist ® (Package Insert). Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc. 2010.

4 Omniscan™ (Package Insert). Princeton, NJ: GE Healthcare, Inc. 2010.

5 MultiHance® (Package Insert). Princeton, NJ: Bracco Diagnostics Inc. 2010.

6 ProHance® (Package Insert). Princeton, NJ : Bracco Diagnostics Inc. 2010.

7 OptiMARK™ (Package Insert). St. Louis, MO: Mallinckrodt Inc. 2010

8 Gadavist™ (Package Insert). Wayne, NJ: Bayer HealthCare Pharmaceuticals Inc. 2011.

9 © 2001-2010 AMR/Arlington Medical Resources, LLC All right reserved. Reproduction, distribution, transmission or publication is prohibited. Reprinted with permission.

10 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.

11 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.

12 Data on File, Lantheus Medical Imaging, Inc.

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