NewAmsterdam Pharma Receives US Patent for Obicetrapib & Extend it Till July 2043

NewAmsterdam Pharma Receives US Patent for Obicetrapib & Extend it Till July 2043

By, Admin 14 June 2024

NewAmsterdam Pharma receives US patent for obicetrapib; extends patent term until July 2043

Overview

NewAmsterdam Pharma Company N.V., a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease (CVD) with elevated low-density lipoprotein cholesterol (LDL-C), for whom existing therapies are not sufficiently effective or well-tolerated, announced that the United States Patent and Trademark Office (USPTO) has issued US patent No. 12,006,305, titled ‘Salts of Obicetrapib and Processes for their Manufacture and Intermediates Thereof’.

Contents of Newly Issued Patent

  • The newly issued patent contains claims covering amorphous obicetrapib hemicalcium, the solid form that will be used in the Company’s products and will be listed in the US FDA’s “Orange Book” as a drug substance patent, if any such products are approved. 
  • The issuance of this composition of matter patent provides intellectual property protection for obicetrapib until July 2043. 
  • The USPTO has now issued or allowed a total of nine patents covering obicetrapib and its uses.

From  the CEO: NewAmsterdam

  • “We are excited to announce that obicetrapib has been granted our third-generation composition of matter patent by the USPTO, which extends obicetrapib’s IP protection and exclusivity until July 2043, more than 9 years beyond our previous second-generation patent expiration in 2034,” said Michael Davidson, chief executive officer of NewAmsterdam. 
  • “There continues to be a need for a safe, efficacious, oral, and potent LDL-lowering therapy. Securing robust patent protection for obicetrapib enables us both to continue the execution of multiple ongoing pivotal Phase 3 trials, as well as reap the potential benefits of obicetrapib’s scientific innovation years beyond potential US FDA approval.”

Obicetrapib

  • Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. 
  • In each of the company’s phase 2 trials, ROSE2, TULIP, ROSE, and OCEAN, evaluating obicetrapib as monotherapy or combination therapy, the Company observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo. 
  • The company is conducting two phase 3 pivotal trials, BROADWAY and BROOKLYN, to evaluate obicetrapib as a monotherapy used as an adjunct to maximally tolerated lipid-lowering therapies to provide additional LDL-lowering for CVD patients and TANDEM, to evaluate obicetrapib and ezetimibe as a fixed-dose combination. 
  • The Company began enrolling patients in BROADWAY in January 2022, in BROOKLYN in July 2022, and in TANDEM in March 2024; completing enrollment of BROOKLYN in April 2023 and BROADWAY in July 2023. 
  • The company also commenced the phase 3 PREVAIL cardiovascular outcomes trial in March 2022, which is designed to assess the potential of obicetrapib to reduce occurrences of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and non-elective coronary revascularization. 
  • NewAmsterdam completed enrollment of PREVAIL in April 2024 and randomized over 9,500 patients.

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