UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
 
Date of Report (Date of earliest event reported):  December 28, 2012
 
LANTHEUS MEDICAL IMAGING, INC.
(Exact name of registrant as specified in its charter)
 
Delaware	 	333-169785	 	51-0396366	
(State or other jurisdiction of incorporation)	 	(Commission File Number)	 	(IRS Employer Identification No.)	
 
331 Treble Cove Road, North Billerica, MA 01862
(Address of principal executive offices) (Zip code)
 
Registrant’s telephone number, including area code:  (978) 671-8001
 
Not Applicable
(Former name or former address, if changed since last report.)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
 
o           Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
o           Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
o           Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
o           Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 
Item 1.01                                          Entry into a Material Definitive Agreement.
 
License and Distribution Agreement
 
On December 28, 2012, the registrant, Lantheus Medical Imaging, Inc. (the “Company”), entered into a License and Distribution Agreement (the “Agreement”), effective as of January 1, 2013, by and between the Company and FUJIFILM RI Pharma Co., Ltd. (“FRI”).  The Agreement immediately follows the License and Distribution Agreement dated as of January 1, 2003 between the parties, which expired on December 31, 2012, and grants FRI an exclusive and royalty-bearing right to continue the marketing and sale of Cardiolite ®  and Neurolite ®  products in Japan.  The Agreement has an initial term of ten years from the effective date and automatically renews for additional one year periods thereafter.  The Agreement allows for termination upon the occurrence of specified events, including material breach or bankruptcy by either party.
 
A copy of the press release announcing the Agreement is filed herewith as Exhibit 99.1.
 
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Item 9.01                                          Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit
Number	 	Description of Exhibit	
 	 	 	
99.1	 	Press Release, dated January 3, 2013, announcing the Agreement between the Company and FUJIFILM RI Pharma Co., Ltd.	
 
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SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 	LANTHEUS MEDICAL IMAGING, INC.	
 	 	 	
 	By:	/s/ Michael P. Duffy	
 	Name:	Michael P. Duffy	
 	Title:	Vice President and General Counsel	

Date: January 3, 2013
 
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EXHIBIT LIST
 
Exhibit
Number	 	Description of Exhibit	
 	 	 	
99.1	 	Press Release, dated January 3, 2013, announcing the Agreement between the Company and FUJIFILM RI Pharma Co., Ltd.	
 
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Exhibit 99.1

 
CONTACTS:	 	
Lantheus Medical Imaging	Pure Communications	
Linda Lennox	Michele Rozen	
978-671-8854	617-730-8284	
 
Meara Murphy
978-671-8508
 
FOR IMMEDIATE RELEASE
 
Lantheus Medical Imaging and FUJIFILM RI Pharma Renew Long-Term License and Distribution Agreement for Cardiolite and Neurolite in Japan
 
Agreement Extends Partnership in One of the Largest Imaging Agent Markets and Ensures Continued Access to Lantheus’ Radiopharmaceuticals for SPECT
 
No. BILLERICA, Mass. (January 3, 2013) — Lantheus Medical Imaging, Inc., a global leader in developing, manufacturing and distributing innovative diagnostic imaging agents, today announced that it has entered into a new agreement with FUJIFILM RI Pharma Co., Ltd. (FRI) to license and distribute Cardiolite ®  (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) and Neurolite ®  (Kit for the Preparation of Technetium Tc99m Bicisate for Injection) in Japan.  Under the terms of the 10-year agreement effective January 1, 2013, which immediately follows an earlier 10-year agreement with FRI, Lantheus will continue to supply FRI with Cardiolite ®  and Neurolite ®  in finished form as well as provide the raw materials to manufacture and sell the products in unit dose form.  Cardiolite ®  and Neurolite ®  are technetium-based radiopharmaceutical imaging agents used in single-photon emission computed tomography (SPECT).
 
“We are pleased to continue our long-term collaborative relationship with FRI, which we’ve successfully developed over the past ten years,” said Don Kiepert, President and Chief Executive Officer, Lantheus Medical Imaging. “Japan represents one of the largest markets for imaging agents worldwide. As such, we share a joint commitment with FRI to provide proven, reliable medical imaging technologies to healthcare providers and patients. This commitment includes ensuring continued access to Cardiolite ®  and Neurolite ®  for SPECT imaging.”
 
“Lantheus is the ideal partner for FRI in the Japanese diagnostic imaging market as we have a shared view of the clinical value and benefits of radiopharmaceuticals in the diagnosis of disease,” said Yoshiro Kumano, President and Chief Executive Officer, FRI. “Our customers are

 
our top priority, and we will continue to meet their needs by offering Cardiolite® and Neurolite® for use in cardiovascular and brain imaging, respectively.”
 
About Cardiolite®
 
Cardiolite®(Kit for the Preparation of Technetium Tc99m Sestamibi for Injection) has played a vital role in the diagnosis and management of patients with known or suspected coronary artery disease for almost two decades.
 
Indications and Usage:Myocardial Imaging:  Cardiolite® (Kit for the Preparation of Technetium Tc99m Sestamibi for Injection), is a myocardial perfusion agent that is indicated for detecting coronary artery disease by localizing myocardial ischemia (reversible defects) and infarction (non-reversible defects), in evaluating myocardial function and developing information for use in patient management decisions. Cardiolite ®  evaluation of myocardial ischemia can be accomplished with rest and cardiovascular stress techniques (e.g. exercise or pharmacologic stress in accordance with the pharmacologic stress agent’s labeling).
 
Contraindications:None known.
 
Important Safety Information:CardioliteÒ has been rarely associated with acute severe allergic and anaphylactic events of angioedema and generalized urticaria.  In some patients the allergic symptoms developed on the second injection during Cardiolite ® imaging.  The most frequently reported adverse events include headache, chest pain/angina, ST segment changes on ECG, nausea, and abnormal taste and smell. Infrequently, death has occurred 4 to 24 hours after Tc99m Sestamibi use and is usually associated with exercise stress testing (See Section 5.2). Pharmacologic induction of cardiovascular stress may be associated with serious adverse events such as myocardial infarction, arrhythmia, hypotension, bronchoconstriction and cerebrovascular events.
 
Warnings and Precautions:In studying patients in whom cardiac disease is known or suspected, care should be taken to assure continuous monitoring and treatment in accordance with safe, accepted clinical procedure. Caution should be exercised and emergency equipment should be available when administering Cardiolite ® . Before administering Cardiolite ®  patients should be asked about the possibility of allergic reactions to either Cardiolite ®  or MIRALUMA ® . MIRALUMA ®  is an identical compound used in breast imaging. The contents of the vial are intended only for use in the preparation of Technetium Tc99m Sestamibi and are not to be administered directly to the patient without first undergoing the preparative procedure.
 
For full prescribing information, please visit www.cardiolite.com. Cardiolite® is a registered trademark of Lantheus Medical Imaging, Inc.

 
About Neurolite®
 
Neurolite®(Kit for the Preparation of Technetium Tc99m Bicisate for Injection) is a SPECT brain imaging agent for localization of stroke in patients in whom stroke has already been diagnosed.
 
Indications: Neurolite® single photon emission computerized tomography (SPECT) is indicated as an adjunct to conventional CT or MRI imaging in the localization of stroke in patients in whom stroke has already been diagnosed. Neurolite ®  is not indicated for assessment of functional viability of brain tissue or for distinguishing between stroke and other brain lesions.
 
Contraindications:None known.
 
Important Safety Information:In clinical trials, Neurolite® has been administered to 1063 subjects (255 normals, 808 patients).  In the 808 patients with neurologic events, there were 11 (1.4%) deaths, none of which were clearly attributed to Neurolite ® . The following adverse effects were observed in  <  1% of the subjects: headache, dizziness, seizure, agitation/anxiety, malaise/somnolence, parosmia, hallucinations, rash, nausea, syncope, cardiac failure, hypertension, angina, and apnea/cyanosis.
 
Warnings:None known.
 
Precautions: General: Use with caution in patients with renal or hepatic impairment. Technetium Tc99m Bicisate is eliminated primarily by renal excretion. Whether Technetium Tc99m Bicisate is dialyzable is not known. Dose adjustments in patients with renal or hepatic impairment have not been studied.
 
Patients should be encouraged to drink fluids and to void frequently during the 2-6 hours immediately after injection to minimize radiation dose to the bladder and other target organs. As with any other radioactive material, appropriate shielding should be used to avoid unnecessary radiation exposure to the patient, occupational workers, and other people.
 
Radiopharmaceuticals should be used only by physicians who are qualified by specific training in the safe use and handling of radionuclides.
 
For full prescribing information, please visit www.lantheus.com. Neurolite® is a registered trademark of Lantheus Medical Imaging, Inc.
 
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® 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.
 
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.
 
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