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NewAmsterdam Pharma Announces Issuance of Composition of Matter Patent for Obicetrapib by the United States Patent and Trademark Office
-- New patent extends patent term for obicetrapib until July 2043 -- NAARDEN, the Netherlands and MIAMI, June 11, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam
About this update from Newamsterdam Pharma Company N.v.
[{"type":"text","content":" -- New patent extends patent term for obicetrapib until July 2043 -- NAARDEN, the Netherlands and MIAMI, June 11, 2024 (GLOBE NEWSWIRE) -- NewAmsterdam Pharma Company N.V. (Nasdaq: NAMS or “NewAmsterdam” or the “Company”), 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, today announced that the United States Patent and Trademark Office (“USPTO”) has issued U.S. Patent No. 12,006,305, titled “Salts of Obicetrapib and Processes for their Manufacture and Intermediates Thereof.” 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 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 (“IP”) protection for obicetrapib until July 2043. The USPTO has now issued or allowed a total of nine patents covering obicetrapib and its uses. “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, M.D., 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 FDA approval.” About 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 tria...