Lantheus Announces Acceptance of its First-to-File ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate)
11 Janeiro 2024 - 10:00AM
Lantheus Holdings, Inc. (“Lantheus” or the “Company”) (NASDAQ:
LNTH), the leading radiopharmaceutical-focused company committed to
enabling clinicians to Find, Fight and Follow disease to deliver
better patient outcomes, today announced that its Abbreviated New
Drug Application (ANDA) for Lutetium Lu 177 Dotatate
(177Lu-PNT2003), a generic version of LUTATHERA® (lutetium Lu 177
dotatate), has been accepted for filing by the U.S. Food and Drug
Administration (FDA), marking a pivotal moment in the Company’s
commitment to improve patient outcomes. LUTATHERA® is indicated for
the treatment of somatostatin receptor-positive
gastroenteropancreatic neuroendocrine tumors (GEP-NETs), including
foregut, midgut, and hindgut neuroendocrine tumors in adults.
Based on the most recent update to the FDA’s online paragraph IV
database listings,1 Lantheus believes it is the first applicant to
have filed a substantially complete ANDA for Lutetium Lu 177
Dotatate containing a Paragraph IV certification under the
provisions of the Hatch-Waxman Act. Should its ANDA be approved by
the FDA, Lantheus believes it will be eligible for 180 days of
generic marketing exclusivity in the U.S.
Lantheus licensed exclusive worldwide commercialization rights
(excluding certain Asian territories) to 177Lu-PNT2003 from POINT
Biopharma Global, Inc. in December of 2022. To read the press
release announcing that licensing transaction, please click
here.
About Lantheus Lantheus is the leading
radiopharmaceutical-focused company, delivering life-changing
science to enable clinicians to Find, Fight and Follow disease to
deliver better patient outcomes. Headquartered in Massachusetts
with offices in New Jersey, Canada and Sweden, Lantheus has been
providing radiopharmaceutical solutions for more than 65 years. For
more information, visit www.lantheus.com.
Safe Harbor for Forward-Looking and Cautionary
StatementsThis press release contains “forward-looking
statements” that are subject to risks and uncertainties.
Forward-looking statements include, but are not limited to,
statements relating to the potential FDA approval of and potential
generic marketing exclusivity relating to PNT2003 and statements
regarding Lantheus’ expectations, hopes, beliefs, intentions or
strategies regarding the future. Forward-looking statements may be
identified by their use of terms such as “should,” “believe” 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.
LUTATHERA® is a registered trademark of Novartis AG and/or its
affiliates.
Contacts: LantheusMark
KinarneyVice President, Investor
Relations978-671-8842ir@lantheus.com
Melissa Downs Senior Director, External
Communications646-975-2533media@lantheus.com
1 See FDA's list of drug products for which an ANDA has been
received by the Office of Generic Drugs containing a "Paragraph IV"
patent certification.
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