News from a former Ambassador Award Honoree: Amicus Therapeutics Announces Issuance of New U.S. Composition of Matter Patent for Galafold® (migalastat), Strengthening Patent Protection Through 2038

Galafold U.S. Intellectual Property Protection Now Includes 35 Issued Patents, 18 of which expire in 2038

PHILADELPHIA, April 19, 2022 (GLOBE NEWSWIRE) — Amicus Therapeutics (Nasdaq: FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, announced today that the United States Patent and Trademark Office (USPTO) has issued U.S. Patent No. 11,304,940, which is directed to a composition of matter covering migalastat (Galafold®).

The new U.S. patent titled “Methods of Treating Fabry Patients Having Renal Impairments” is directed to a molecule comprising migalastat bound to an alpha-galactosidase A protein and expires in 2038.

John F. Crowley, Chairman and Chief Executive Officer of Amicus stated, “We are very pleased that the USPTO has issued this patent around this unique oral pharmacological chaperone, which builds upon our existing intellectual property portfolio and provides patent protection for Galafold to 2038. The issuance of this very important patent embodies the many years of tremendous hard work, perseverance and ingenuity of the Amicus teams as well as the investment of hundreds of millions of dollars to create and deliver this novel precision medicine to people living with Fabry disease with amenable variants. This patent, in concert with our other 34 orange book listed patents and regulatory exclusivities for Galafold, provide Amicus with broad and long-term intellectual property rights well into the late-2030s.”

Amicus is pursuing corresponding patent applications in other regions and countries, including Europe and Japan.

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