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LANTHEUS HOLDINGS, INC.

(LNTH)
  Report
Delayed Nasdaq  -  04:00:00 2023-01-27 pm EST
56.20 USD   +0.64%
01/13POINT Biopharma Completes Randomization in PNT2002's Phase 3 SPLASH TrialEnrollment for the randomization phase of SPLASH completed prior to EOY 2022, meeting previous guidance
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01/13POINT Biopharma Completes Randomization in PNT2002's Phase 3 SPLASH Trial
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01/12POINT Biopharma Completes Randomization in PNT2002’s Phase 3 SPLASH Trial
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Lantheus Announces the Approval of DEFINITY« (Perflutren Lipid Microsphere) by China’s NMPA

11/28/2022 | 08:00am EST

Lantheus Holdings, Inc. announced that the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) has approved the Import Drug License (IDL) for Perflutren Lipid Microsphere Injectable Suspension (marketed as DEFINITY® in the U.S.), the Company's diagnostic ultrasound enhancing agent for patients with suboptimal echocardiograms. The Company's partner, China Resources Double-Crane Pharmaceutical Co. Ltd. (CR Double-Crane), will be responsible for commercializing DEFINITY in China under a local brand name. Under the distribution agreement, Lantheus will supply DEFINITY to CR Double-Crane for a launch in China.

With this approval, DEFINITY is indicated in China for use in patients with suboptimal conventional echocardiography and to better identify the left ventricular endocardial border. Lantheus entered into a development and distribution arrangement with CR Double-Crane for the commercialization of DEFINITY in China, Hong Kong and Macau. As part of the agreement with Lantheus, CR Double-Crane conducted confirmatory clinical trials with DEFINITY on Lantheus' behalf in pursuit of cardiac, liver and kidney imaging indications, as well as a pharmacokinetic study.

The efficacy of DEFINITY administration during echocardiography was assessed in a prospective independent blinded evaluation of non-contrast and DEFINITY contrast images for left ventricular endocardial border delineation (i.e., assessment of left ventricular endocardial segments) and left ventricular opacification in more than 600 subjects. These subjects came from clinical trials that enrolled similar patient populations with suboptimal echocardiography images, study designs and imaging procedures. The confirmatory study conducted in China in 120 subjects (DEFINITY 311) confirmed the findings reported for the North American population.

The safety data included several clinical trials that evaluated the use of activated DEFINITY in 1,716 patients (1063; 61.9% were male and 653; 38.1% were female) with a mean age of 56.1 (range 18 to 93). Of these, 144 (8.4%) patients had at least one treatment-related adverse reaction. Among the 1,716 DEFINITY patients studied, serious adverse events were reported in 30 patients.

None of the serious adverse events were considered related to DEFINITY administration. Adverse events appeared within minutes (1 - 15 min) of the drug administration and were of moderate intensity, resolving usually without treatment within minutes or hours after onset. Sub-analyses by age, gender and race were performed.

The overall incidence of adverse events was similar for the <65-year age group and the =65-year age group, similar in males and in females, and similar among all racial or ethnic groups. The most frequent adverse events were reported for the central and peripheral nervous system (3.1%), body as a whole (2.4%) and gastrointestinal system (1.8%). The most frequently occurring treatment-related adverse experiences were headache (2.3%), back/renal pain (1.2%), ?ushing (1.1%) and nausea (1.0%).


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All news about LANTHEUS HOLDINGS, INC.
01/13POINT Biopharma Completes Randomization in PNT2002's Phase 3 SPLASH TrialEnrollment for..
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01/13POINT Biopharma Completes Randomization in PNT2002's Phase 3 SPLASH Trial
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01/12POINT Biopharma Completes Randomization in PNT2002’s Phase 3 SPLASH Trial
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Financials (USD)
Sales 2022 917 M - -
Net income 2022 200 M - -
Net Debt 2022 - - -
P/E ratio 2022 19,9x
Yield 2022 -
Capitalization 3 793 M 3 793 M -
Capi. / Sales 2022 4,14x
Capi. / Sales 2023 3,65x
Nbr of Employees 612
Free-Float 97,6%
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Number of Analysts 6
Last Close Price 56,20 $
Average target price 100,33 $
Spread / Average Target 78,5%
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Managers and Directors
Mary Anne Heino Chief Commercial Officer
Robert J. Marshall Chief Financial Officer & Treasurer
Brian A. Markison Director
Simon Robinson Senior VP-Research & Pharmaceutical Development
Bela S. Denes Vice President-Medical Affairs
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