Lantheus Announces Acceptance of its First-to-File ANDA for Generic LUTATHERA® (Lutetium Lu 177 Dotatate)
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Insights
The acceptance of Lantheus Holdings' ANDA for Lutetium Lu 177 Dotatate by the FDA represents a significant milestone in the company's efforts to penetrate the radiopharmaceutical market with a generic alternative to LUTATHERA®. The potential market exclusivity for 180 days post-approval could provide Lantheus with a temporary competitive advantage, allowing them to capture market share and establish their product before other generic competitors enter the market.
Given that GEP-NETs are a relatively rare group of cancers, the size of the target market is limited, which typically results in higher drug prices due to the lack of large patient populations that usually drive competition. The introduction of a generic version could substantially reduce treatment costs, potentially increasing accessibility for patients. However, the actual impact on Lantheus' financials would depend on the pricing strategy, production costs and the ability to scale up manufacturing to meet demand.
It is also important to consider the strategic partnership with POINT Biopharma Global Inc., which could leverage Lantheus' commercialization capabilities while expanding POINT Biopharma's reach beyond their retained Asian territories.
Lutetium Lu 177 Dotatate is a targeted radioligand therapy that binds to somatostatin receptors, which are commonly overexpressed in GEP-NETs. The therapy delivers a radioactive isotope directly to the tumor cells, providing a treatment option with a mechanism of action that differs from traditional chemotherapy. The acceptance of the ANDA signifies the FDA's initial confirmation that Lantheus' generic product is sufficiently similar to LUTATHERA® to warrant a full review for safety, efficacy and manufacturing quality.
Should the ANDA be approved, it could lead to wider adoption of peptide receptor radionuclide therapy (PRRT) in the treatment of GEP-NETs due to reduced costs. However, the long-term impact on patient outcomes and the broader healthcare system would need to be evaluated through post-market surveillance and real-world evidence studies.
The Paragraph IV certification is a critical aspect of the Hatch-Waxman Act, allowing generic drug manufacturers to challenge the patents of brand-name drugs. By being the first to file a substantially complete ANDA with a Paragraph IV certification, Lantheus is positioning itself to capitalize on the 180-day exclusivity period, which is designed to reward the risk taken in potentially infringing upon existing patents.
This legal maneuvering could have a considerable impact on the company's market position and profitability, provided that there are no successful legal challenges from the brand-name patent holders. The outcome of any such litigation could significantly affect the timeline for generic entry and thus the financial projections for Lantheus.
BEDFORD, Mass., Jan. 11, 2024 (GLOBE NEWSWIRE) -- 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 Statements
This 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:
Lantheus
Mark Kinarney
Vice President, Investor Relations
978-671-8842
ir@lantheus.com
Melissa Downs
Senior Director, External Communications
646-975-2533
media@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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