UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD. |
On January 26, 2024, Lantheus Holdings, Inc. (the “Company”) confirmed that the Company and its subsidiary, Lantheus Medical Imaging, Inc., were sued by Advanced Accelerator Applications USA, Inc. and Advanced Accelerator Applications SA, each a Novartis entity, for patent infringement in response to the Company’s filing of Abbreviated New Drug Application (“ANDA”) No. 217060 for Lutetium Lu 177 Dotatate (177Lu-PNT2003), a generic version of LUTATHERA® (lutetium Lu 177 dotatate). 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, the Company 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. As the “first applicant,” the Company believes it is eligible for 180 days of generic marketing exclusivity in the U.S. The plaintiff has filed a lawsuit for patent infringement against the Company in the United States District Court for the District of Delaware.
The information furnished pursuant to this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities under that Section and shall not be deemed to be incorporated by reference into any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act.
This Form 8-K 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 177Lu-PNT2003 and statements regarding the Company’s 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.
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 HOLDINGS, INC. | ||
| By: | /s/ Daniel M. Niedzwiecki | |
| Name: | Daniel M. Niedzwiecki | |
| Title: | Chief Administrative Officer and General Counsel | |
Date: January 26, 2024