Pharma Focus Europe

Galmed Announces Issuance of New Composition of Matter Patent for Aramchol meglumine Salt

Thursday, February 09, 2023

Galmed Pharmaceuticals Ltd., a clinical-stage biopharmaceutical company for liver, metabolic and inflammatory diseases announced today that the United States Patent and Trademark Office (USPTO) granted Galmed United States Patent 11,571,431 B2, which is expected to provide exclusivity of Aramchol meglumine salt until December 2034. With the latest patent, Galmed is fortifying the IP protection of its lead compound, Aramchol, extending Aramchol's IP protection until end of 2038 (for its longest-term patent in US).

Similar composition of matter patents have been granted in Canada, Europe, Australia, China, Hong-Kong, Korea, Israel, Japan and other territories for Aramchol salts. Specifically, the invention provides the Aramchol amine salts and use thereof in medical treatment having advantageous physicochemical properties. In particular, the N-methylglucamine (meglumine) salt has been shown to possess advantageous properties, including increased solubility, as well as increased absorption and exposure, which correlate with higher bioavailability. These patents further confirm Galmed's innovative drug developments are covered by the same level of robust protection as traditional new chemical entities.

In total, Galmed's research and development platform has produced a patent portfolio comprising over 20 issued patents covering key pharmaceutical markets.

"This new patent which covers critical compositions of matter enhances our already robust patent portfolio, further strengthening and extending the potential commercial horizon for Aramchol," said Allen Baharaff, President and Chief Executive Officer of Galmed Pharmaceuticals. "We expect that this long patent runway will assist us in maximizing the full therapeutic potential of Aramchol, which we are currently investigating across a number of potential anti-fibrotic indications."

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