Lantheus Medical Imaging to Present Data on Novel PET Cardiac and Heart Failure Imaging Agents at SNM 58th Annual Meeting

NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic imaging, today announced that data from the Phase 2 clinical trial for the assessment of myocardial perfusion using Positron Emission Tomography (PET) imaging of flurpiridaz F 18 in patients with suspected or known coronary artery disease (CAD) will be presented in a series of oral and poster presentations at the SNM 58^th Annual Meeting, being held June 4-8 in San Antonio. In addition, the Company will be presenting data on LMI 1195, a novel cardiac neuronal PET imaging agent in development to improve the evaluation and management of patients with heart failure.

“Comparison of flurpiridaz F 18 and FDG for assessment of left ventricular tissue mass following myocardial infarction in rats”

"We are pleased to present eight poster and oral presentations on our cardiovascular PET imaging pipeline candidates at the SNM annual meeting,” said Don Kiepert, President and Chief Executive Officer of Lantheus Medical Imaging. “In recent years, we have seen considerable growth in the support of PET imaging. Lantheus is committed to advancing our pipeline of next generation diagnostic medical imaging products, and we see great promise in flurpiridaz F 18 and LMI 1195 as novel PET imaging tools for the diagnosis and evaluation of coronary artery disease and heart failure.”

The schedule and abstract information for the presentations are listed below:

Presentations featuring flurpiridaz F 18:

Oral Session: “Remote camera qualification (RCQ) of PET and PET/CT scanners for BMS747158 F18 myocardial perfusion Phase 3 clinical trial using a standardized phantom procedure,” Sunday, June 5, 1:45 p.m. CT, Room 214D (Abstract No. 54)
Oral Session: “Phase 2 clinical comparison of flurpiridaz F 18 injection PET and SPECT myocardial perfusion imaging for diagnosis of coronary artery disease,” Sunday, June 5, 4:51 p.m. CT, Room 213AB (Abstract No. 59)
Poster Session: “Streamlined quantification of absolute MBF at rest and stress with flurpiridaz F 18 injection PET in normal subjects and patients with coronary artery disease (CAD),” Monday, June 6, 2:30 p.m. CT, Exhibit Hall B (Abstract No. 1114)
Poster Session: “Relative defect radioactivity and perceived defect severity are proportional with flurpiridaz F 18 PET myocardial perfusion imaging,” Monday, June 6, 2:30 p.m. CT, Exhibit Hall B (Abstract No. 1115)
Poster Session: “Comparison of flurpiridaz F 18 and FDG for assessment of left ventricular tissue mass following myocardial infarction in rats,” Monday, June 6, 2:30 p.m. CT, Exhibit Hall B (Abstract No. 1097)
Oral Session: “Comparison of flurpiridaz F 18 PET injection and Tc-99m labeled SPECT myocardial perfusion imaging for identifying severity and extent of stress induced myocardial ischemia in Phase 2 clinical trials,” Tuesday, June 7, 5:30 p.m. CT, Room 213AB (Abstract No. 444)

Presentations featuring LMI 1195:

Poster Session: “Roles of cardiac norepinephrine uptake 1 and 2 in evaluation of LMI 1195, a new cardiac PET neuronal imaging agent, in rats, rabbits and nonhuman primates,” Monday, June 6, 2:30 p.m. CT, Exhibit Hall B (Abstract No. 1099)
Poster Session: “LMI 1195 PET neuronal imaging: Evaluation of cardiac denervation, re-innervation and associated susceptibility to arrhythmia,” Monday, June 6, 2:30 p.m. CT, Exhibit Hall B (Abstract No. 1103)

In addition, Dana S. Washburn, M.D., Vice President, Clinical Development and Medical Affairs at Lantheus Medical Imaging, will deliver a presentation titled “Developing Novel Cardiovascular Imaging Agents: From Concept Through Clinical Trials,” as part of a session titled “Emerging Technologies: Translating Molecular Imaging Agents Into the Clinic” being held on Tuesday, June 7 from 8:00 to 11:15 a.m. CT in Room 103A. This presentation will review the development paradigm for cardiovascular molecular imaging agents focusing on the highlights of each phase from preclinical through the sequential phases of clinical trials. Dr. Washburn will present highlights of the flurpiridaz F 18 and LMI 1195 programs to illustrate the unique challenges of successful translation of imaging agents from preclinical characterization to evaluation in human clinical trials.

Lantheus recently presented full Phase 2 study results for flurpiridaz F 18 at ICNC10 in May in Amsterdam. The findings demonstrated PET myocardial perfusion imaging with flurpiridaz F 18 provided superior image quality, diagnostic certainty and diagnostic performance for detecting CAD compared to single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI), the current standard for the non-invasive detection of CAD. The data also demonstrated a positive safety profile for PET imaging with flurpiridaz F 18.

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 for the diagnosis of CAD. PET imaging with flurpiridaz F 18 has the potential to be a new clinical tool for the evaluation of myocardial perfusion that may better evaluate patients with known or suspected CAD in comparison to other non-invasive diagnostic modalities. CAD is the most common form of heart disease, affecting approximately 16.8 million people in the United States². CAD is the leading cause of death in the United States for both men and women³. Each year more than half a million Americans die from CAD³.

About PET and MPI

Positron Emission Tomography, also called PET imaging or a PET scan, is a type of nuclear medicine imaging procedure⁴ 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 structure⁵. Myocardial perfusion imaging (MPI) is a non-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 disease⁶. Although single-photon emission computer tomography (SPECT) is most commonly used for MPI⁷, 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 stratification⁸.

About LMI 1195

LMI 1195 is a novel F-18 tracer designed to use positron emission tomography to improve imaging of cardiac neuronal function. LMI 1195 has completed Phase 1 clinical trials. In preclinical studies, LMI 1195 showed promise as a heart failure imaging agent with high cardiac sympathetic nervous system uptake⁹.

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. 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 info.

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.

² Cleveland Clinic. Coronary Artery Disease – Risk Factors. http://my.clevelandclinic.org/heart/prevention/riskfactors.aspx. Accessed on May 26, 2011.

³ National 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 on May 26, 2011.

⁴ Radiology Info. What is Positron Emission Tomography – Computed Tomography (PET/CT) Scanning. http://www.radiologyinfo.org/en/info.cfm?pg=PET. Accessed on May 26, 2011.

⁵ National Institutes of Health. NIH Clinical Center. Positron Emission Tomography Department Overview. http://clinicalcenter.nih.gov/pet/. Accessed on May 26, 2011.

⁶ Society of Nuclear Medicine. Procedure Guidelines for Myocardial Perfusion Imaging. Version 3.0 June 2002. http://interactive.snm.org/docs/pg_ch02_0403.pdf.

⁷ Salerno, M and Beller, GA, Noninvasive Assessment of Myocardial Perfusion. Circ Cardiovasc Imaging. 2009; 2:412-424.

⁸ 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. ⁹ Bozek, J, Silva, P, Lamoy, M, Azure, M, Radeke, H, Robinson, S, and Yu, M. Heart Failure Imaging in the Rat with LMI1195, a New PET Cardiac Neuronal Imaging Agent. Circulation 2009;120(S18) S362.