Full Press Release Details
Lantheus Holdings, Inc. Announces FDA Approval of
DEFINITY Room Temperature
Commercially Available in Early 2021
NORTH BILLERICA, MA., November 18, 2020 - Lantheus Holdings, Inc. (the Company ) (NASDAQ: LNTH), the parent company of Lantheus Medical
Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products, today announced the U.S. Food and Drug Administration (FDA)
has approved the supplemental new drug application (sNDA) for DEFINITY Room Temperature
(DEFINITY RT) (Perflutren Lipid Microsphere) Injectable Suspension.
With the approval of DEFINITY RT, we expand our microbubble franchise
offering to include a room temperature formulation, in addition to our market leading, refrigerated DEFINITY that our customers and patients have trusted to enhance suboptimal echocardiograms for 19 years. This approval will enable those customers
who prefer a non-refrigerated product to be able to continue to benefit from our DEFINITY microbubble products, said Paul Blanchfield, Chief Commercial Officer.
Mary Anne Heino, President and Chief Executive Officer, added, We continue to expand the offerings in our microbubble franchise. The addition of
DEFINITY RT recognizes the increasing need for portability in delivery of healthcare services as well as our commitment to partnering with innovators developing complex product formulations which include a microbubble. I am thankful to the entire
Lantheus team who worked diligently to bring this new formulation to the market.
DEFINITY RT is a modified formulation of DEFINITY that allows both
storage and shipment at room temperature (DEFINITY s previously approved formulation requires refrigerated storage). The activation of DEFINITY RT will be achieved using the VIALMIX RFID
device, which was approved in August 2020. This modified formulation provides clinicians an additional choice and allows for greater utility of this formulation in broader clinical settings.
The composition of matter U.S. issued patent for DEFINITY RT has an expiration date of 2035 and will be listed in the Orange Book.
About DEFINITY and DEFINITY RT
DEFINITY Vial for (Perflutren Lipid Microsphere) Injectable Suspension and DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension (activated) are
ultrasound enhancing agents for use in patients with suboptimal echocardiograms (see Indications and Important Safety Information below and find full Prescribing Information at www.definityimaging.com).1,2 DEFINITY and DEFINITY RT are engineered to produce small and consistently sized durable microbubbles to fully evaluate the left ventricle.1,2
DEFINITY has extensive safety experience and a consistent safety profile.3 Since its launch in 2001, more than 14 million echo studies have been performed with DEFINITY, and it
is the most prescribed ultrasound enhancing agent in the U.S.4
DEFINITY Vial for (Perflutren Lipid
Microsphere) Injectable Suspension
DEFINITY RT (Perflutren Lipid Microsphere) Injectable
Activated DEFINITY and activated DEFINITY RT (Perflutren Lipid Microsphere) Injectable Suspension are 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.
Do not administer DEFINITY and
DEFINITY RT to patients with known or suspected hypersensitivity to perflutren lipid microsphere or its components.
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.
In post-marketing use, rare but serious cardiopulmonary or hypersensitivity 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 Adverse Reactions (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 accompanying full Prescribing
Information, including boxed WARNING regarding serious cardiopulmonary reactions, on www.definityimaging.com.
About Lantheus Holdings,
Lantheus Holdings, Inc. is the parent company of Lantheus Medical Imaging, Inc. and Progenics Pharmaceuticals, Inc., and a global leader in the
development, manufacture and commercialization of innovative diagnostic and therapeutic agents and products. Lantheus provides a broad portfolio of products, including the echocardiography 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; AZEDRA for the treatment of certain rare neuroendocrine tumors; and RELISTOR for the treatment
of opioid-induced constipation, which is partnered with Bausch Health Companies, Inc. The Company is headquartered in North Billerica, Massachusetts with offices in New York, New Jersey, Puerto Rico, Canada and Sweden. For more information, visit
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, as amended, that
are subject to risks and uncertainties and are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking
statements may be identified by their use of terms such as anticipate, believe, confident, could, estimate, expect, intend, may, plan,
predict, project, target, will and other similar terms. Such forward-looking statements are based upon current plans, estimates and expectations that are subject to risks and uncertainties that could
cause actual results to materially differ from those described in the forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation that such plans, estimates and expectations will be achieved.
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. Risks and uncertainties that could cause our actual results to materially differ from those described in the forward-looking statements include (i) our
future operating results; (ii) the impact of the COVID-19 pandemic on our business, financial condition and prospects; (iii) the Company s ability to successfully launch DEFINITY RT as a
commercial product and the timing of the launch; (iv) the intellectual property protection of DEFINITY RT; (v) expectations for future clinical trials, the timing and potential outcomes of clinical studies and filings and other
interactions with regulatory authorities; and (vi) the risk and uncertainties discussed in our filings with the Securities and Exchange Commission (including those described in the Risk Factors section in our Annual Reports on Form 10-K and our Quarterly Reports on Form 10-Q).
1 DEFINITY (Package Insert), North Billerica, MA, Lantheus Medical Imaging, Inc.
2 DEFINITY RT (Package Insert), North
Billerica, MA, Lantheus Medical Imaging, Inc.
3 Data on file, Lantheus Medical
Reprinted with permission.
Senior Director, Investor Relations
Director, Corporate Communications