Exhibit 99.1
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, USA; June 11, 2024 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 Companys products and will
be listed in the FDAs 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 obicetrapibs 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 obicetrapibs 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 Companys 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.
About NewAmsterdam
NewAmsterdam Pharma (Nasdaq: NAMS) is
a late-stage biopharmaceutical company whose mission is to improve patient care in populations with metabolic diseases where currently approved therapies have not been adequate or well tolerated. We seek to fill a significant unmet need for a safe,
well-tolerated and convenient LDL-lowering therapy. In multiple phase 3 studies, NewAmsterdam is investigating obicetrapib, an oral, low-dose and once-daily CETP
inhibitor, alone or as a fixed-dose combination with ezetimibe, as LDL-C lowering therapies to be used as an adjunct to statin therapy for patients at risk of CVD with elevated
LDL-C, for whom existing therapies are not sufficiently effective or well tolerated.