NORTH BILLERICA, Mass.--(BUSINESS WIRE)--Feb 23, 2012-- Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, today announced a strategic distribution arrangement for DEFINITY(R) Vial for (Perflutren Lipid Microsphere) Injectable Suspension in the People's Republic of China, including Hong Kong S.A.R. and Macau S.A.R.
The Board of Directors of both Lantheus and Beijing Double-Crane Pharmaceutical Co., LTD. ("Double-Crane"), a leading pharmaceutical company based in Beijing, have approved a 15-year agreement for exclusive distribution and supply of DEFINITY(R), an ultrasound contrast agent for use in the field of echocardiograms. This agreement expands global access to DEFINITY(R) in a key geographic region.
DEFINITY(R) is currently approved in North America, Europe, and a number of other countries. Lantheus and Double-Crane plan to fully execute the agreement in the next several weeks in China.
Under the terms of the agreement, both parties will collaborate on confirmatory clinical trials to commercialize DEFINITY(R) in China for use in cardiac disease. Double-Crane will conduct the clinical trials once the design has been agreed upon with Lantheus, and Lantheus will provide regulatory support and product for the trials. Furthermore, Lantheus and Double-Crane will work together to develop other new indications.
The agreement also provides Double-Crane the right of first negotiation to manufacture DEFINITY(R) in China upon the achievement of certain sales levels. In addition, Double-Crane has the right to negotiate the manufacture of DEFINITY(R) in China in the event Lantheus chooses to seek a Chinese manufacturing partner for the product.
"The distribution and supply agreement with Double-Crane supports our commitment to global expansion to help improve the treatment of human disease in key international markets," said Don Kiepert, President and Chief Executive Officer, Lantheus Medical Imaging. "DEFINITY(R) is an important diagnostic tool that can provide critical patient information to help physicians make more informed patient management decisions. We are pleased to announce this agreement to enter the Chinese market and look forward to working closely with such an esteemed partner as Double-Crane to make DEFINITY(R) available to both physicians and patients in China." Double-Crane is focused on the development of products in the area of cardiovascular disease. This partnership with Lantheus is part of Double-Crane's strategic development plan in support of China's "National 12th Five-Year Development Program." This partnership will support Double-Crane in achieving its objective to enhance its product pipeline with a globally-branded drug, such as DEFINITY(R).
"We are very pleased to be the exclusive distributor of DEFINITY(R) in China," said Li Xin, President of Double-Crane. "Distribution of DEFINITY(R) into China will significantly help Chinese physicians to diagnose diseases and provides a new tool for the management of patient care. We believe DEFINITY(R) will also bring a great economic outcome in health care management in China. In addition, DEFINITY(R) will play an important role in the portfolio of cardiovascular products of Double-Crane. The exclusive distribution and supply of DEFINITY(R) will enhance our competitive advantage in the area of cardiovascular diseases." About DEFINITY (R) DEFINITY(R) Vial for (Perflutren Lipid Microsphere) Injectable Suspension is an ultrasound contrast agent for use in patients with suboptimal echocardiograms (see Indications below and find full Prescribing Information at http://www.definityimaging.com)1. Since its launch in 2001, activated DEFINITY(R) has been administered to more than three million patients2.
INDICATIONS Activated DEFINITY(R) (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(R) 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 uncommonly during or following perflutren-containing microsphere administration See WARNINGS AND PRECAUTIONS (5.1). Most serious reactions occur within 30 minutes of administration.
-- Assess all patients for the presence of any condition that precludes DEFINITY(R) administration See CONTRAINDICATIONS (4).
-- 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 (6). The risk for these reactions may be increased among patients with unstable cardiopulmonary conditions See Postmarketing Experience (6.2). It is not always possible to reliably establish a causal relationship to drug exposure due to the presence of underlying cardiopulmonary disease.
Please see full Prescribing Information, including boxed WARNING regarding serious cardiopulmonary reactions, on www.definityimaging.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 Company's 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(R) 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(R) (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(R) (Technetium Tc99m Generator), Cardiolite(R) (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.
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(R) (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc., 2011.
2 5/82001-2010 AMR/Arlington Medical Resources, LLC All right reserved.
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Reprinted with permission.
CONTACT: Lantheus Medical Imaging Linda Lennox, 978-671-8854 or Meara Murphy, 978-671-8508 or Pure Communications Michele Rozen, 617-730-8284 KEYWORD: UNITED STATES ASIA PACIFIC NORTH AMERICA CHINA MASSACHUSETTS INDUSTRY KEYWORD: SURGERY HEALTH CARDIOLOGY MEDICAL DEVICES RESEARCH SCIENCE MANAGED CARE SOURCE: Lantheus Medical Imaging, Inc.
Copyright Business Wire 2012 PUB: 02/23/2012 04:47 PM/DISC: 02/23/2012 04:48 PM http://www.businesswire.com/news/home/20120223006784/