Press Release Details

NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Nov. 2, 2015-- Lantheus Holdings, Inc. (the “Company”) (NASDAQ: LNTH), the parent company of Lantheus Medical Imaging, Inc. (“LMI”), a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents and products, today announced that data from a sub-analysis of its first Phase 3 study of flurpiridaz F 18 for myocardial perfusion imaging (MPI) will be presented at the American Heart Association 2015 Scientific Sessions, being held November 7-11, 2015 in Orlando, Florida. Flurpiridaz F 18 is an investigational positron emission tomography (PET) MPI agent in Phase 3 development.

The poster (#4424), “Improved Assessment of CAD in Women with Flurpiridaz F 18 PET Myocardial Perfusion Imaging: A Subset Analysis of the Flurpiridaz F 18 301 Phase 3 Study,” will be presented by Gary V. Heller, M.D., of Morristown Medical Center on Sunday, November 8, 2015 at 2:00-3:15 p.m. EST in the Nuclear Cardiology: Advances in SPECT and PET Imaging session of the meeting.

The data are from a multicenter, international (United States, Canada, and Finland) Phase 3 study designed to evaluate the diagnostic efficacy of flurpiridaz F 18 PET MPI, compared with single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease. Approximately 800 patients with known or suspected CAD who were either scheduled for or had completed invasive coronary angiography (without intervention) were enrolled in the trial. The subset analysis focused on the female sub-population.

About Flurpiridaz F 18 Injection and Coronary Artery Disease
Flurpiridaz F 18 injection, a fluorine 18-labeled agent that binds to mitochondrial complex 1 (MC-1)¹, was designed to be a novel myocardial perfusion PET imaging agent that may better evaluate patients with known or suspected CAD, which is the most common form of heart disease², affecting an estimated 15.4 million Americans 20 years of age or older³. CAD is the leading cause of death in the United States for both men and women². Each year more than 400,000 Americans die from CAD². Despite increases in awareness over the past decade, only 54% of women recognize that heart disease is their number one killer, accounting for one in every four female deaths⁴. Heart disease and related risk factors are often missed in women and symptoms of coronary artery disease are often different in women than their male counterparts⁵. In the first phase 3 study, flurpiridaz F 18 demonstrated improved CAD detection and reduced radiation exposure in women over standard SPECT MPI.

About PET and MPI
Positron emission tomography, also called PET imaging or a PET scan, is a type of nuclear medicine imaging procedure⁶ that provides information about the function and metabolism of the body’s organs, unlike computed tomography (CT) or magnetic resonance imaging (MRI), which primarily show anatomy and structure⁷. MPI is a minimally invasive test that utilizes a small amount of radioactive material (radiopharmaceutical) injected into the body to depict the distribution of blood flow to the heart. MPI is used to identify areas of reduced blood flow (perfusion) to the heart muscle. The test is typically conducted under both rest and stress conditions, after which physicians examine and compare the two scans and predict whether the patient has significant coronary artery disease⁸. Although SPECT is most commonly used for MPI⁹, PET imaging has gained considerable support and use in the field of cardiovascular imaging, as it offers many advantages to SPECT, including higher spatial and contrast resolution, which results in higher image quality and improved diagnostic accuracy, accurate attenuation correction and risk stratification¹⁰.

About Lantheus Holdings, Inc. and Lantheus Medical Imaging, Inc.
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. (“LMI”), which is a global leader in developing, manufacturing, selling and distributing innovative diagnostic imaging agents and products. LMI provides a broad portfolio of products, which are primarily used for the diagnosis of cardiovascular diseases. LMI’s key products include the echocardiography contrast agent DEFINITY^® Vial for (Perflutren Lipid Microsphere) Injectable Suspension; TechneLite^® (Technetium Tc99m Generator), a technetium-based generator that provides the essential medical isotope used in nuclear medicine procedures; and Xenon (Xenon Xe 133 Gas), an inhaled radiopharmaceutical imaging agent used to evaluate pulmonary function and for imaging the lungs. The Company is headquartered in North Billerica, Massachusetts, and has 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. 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 Yalamanchili, P, Wexler, E, Hayes, M, Yu, M, MD, Bozek J, Radeke, H, Azure, M, Purohit, A, Casebier, DS, and Robinson, SP. Mechanism of uptake and retention of 18F BMS-747158-02 in cardiomyocytes: A novel PET myocardial imaging agent. Journal Nuclear Cardiology 2007 Nov-Dec;14(6):782-8.

²National Institutes of Health, National Heart, Lung, and Blood Institute. Coronary Artery Disease: Who Is At Risk. http://www.nhlbi.nih.gov/health/dci/Diseases/Cad/CAD_WhoIsAtRisk.html. Accessed October 2015.

³ Heart Disease and Stroke Statistics. 2014 Update: A Report From the American Heart Association. Circulation. 2014;129:e28-e292.

⁴National Center for Chronic Disease Prevention and Health Promotion. Division for Heart Disease and Stroke: Women and Heart Disease Fact Sheet. http://www.cdc.gov/dhdsp/data_statistics/fact_sheets/fs_women_heart.htm. Accessed October 2015.

⁵American College of Cardiology. Women and Coronary Artery Disease. https://www.cardiosmart.org/Heart-Conditions/Women-and-Coronary-Artery-Disease. Accessed October 2015.

⁶ Radiology Info. What is Positron Emission Tomography – Computed Tomography (PET/CT) Scanning. http://www.radiologyinfo.org/en/info.cfm?pg=PET. Accessed October 2015.

⁷National Institutes of Health. NIH Clinical Center. Positron Emission Tomography Department Overview. http://clinicalcenter.nih.gov/pet/. Accessed October 2015.

⁸Society of Nuclear Medicine. Procedure Guidelines for Myocardial Perfusion Imaging. Version 3.0 June 2002. http://interactive.snm.org/docs/pg_ch02_0403.pdf.

⁹ Salerno, M and Beller, GA, Noninvasive Assessment of Myocardial Perfusion. Circ Cardiovasc Imaging. 2009; 2:412-424.

¹⁰ Heller, G, Calnon, D and Dorbala, S. Recent Advances in Cardiac PET and PET/CT Myocardial Perfusion Imaging. J Nucl Cardiol 2009; 16:962-9.

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Source: Lantheus Holdings, Inc.

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