New Patent Extends Obicetrapib's IP Protection

By Bobby Samwell • Tuesday, June 11 15:08 • Permanent Link

NewAmsterdam Pharma Company N.V. (NASDAQ: NAMS) has announced the issuance of a composition of matter patent for Obicetrapib by the United States Patent and Trademark Office (USPTO). This new patent extends the patent term for Obicetrapib until July 2043.

The newly issued patent, U.S. Patent No. 12,006,305, covers 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. This 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, indicating a strong IP protection strategy.

Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam, highlighted the significance of this new patent, noting that it extends Obicetrapib’s IP protection and exclusivity for more than 9 years beyond the previous second-generation patent expiration in 2034.

Obicetrapib is a novel, oral, low-dose CETP inhibitor that NewAmsterdam is developing to overcome the limitations of current LDL-lowering treatments. The company has observed statistically significant LDL-lowering combined with a side effect profile similar to that of placebo in phase 2 trials.

NewAmsterdam is currently 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. Additionally, the company 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.

In terms of financial metrics, the press release did not provide specific figures or changes in financial performance. However, the focus was on the extension of intellectual property protection for Obicetrapib and the progress in clinical trials, indicating a strong emphasis on product development and regulatory milestones. As a result of these announcements, the company's shares have moved 1.0% on the market, and are now trading at a price of $19.89. For more information, read the company's full 8-K submission here.

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