Amicus Therapeutics Inc.

10/17/2024 | Press release | Distributed by Public on 10/17/2024 05:01

Material Event Form 8 K

Item 8.01 Other Events.

On October 15, 2024, Amicus Therapeutics, Inc. (the "Company") and its subsidiary Amicus Therapeutics US, LLC (collectively, "Amicus"), entered into a license agreement with Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (collectively, "Teva") resolving the previously disclosed patent litigation concerning the submission by Teva of an Abbreviated New Drug Application ("ANDA") seeking approval to market a generic version of GalafoldĀ® (migalastat) 123 mg oral capsules prior to the expiration of Amicus's Orange Book listed patents (the "License Agreement").

Under the terms of the License Agreement, among other things, Amicus granted Teva a non-exclusive, non-transferable, royalty-free, fully paid-up license to commercialize its generic version of Galafold in the United States commencing on January 30, 2037, or earlier in certain circumstances. The parties will file the License Agreement with the Federal Trade Commission and the Department of Justice, pursuant to applicable law, and will terminate their pending litigation pursuant to a consent judgment and permanent injunction that is subject to court approval. Similar patent litigation previously disclosed by the Company will continue against Aurobindo (Aurobindo Pharma LTD and Aurobindo Pharma USA, Inc.) as the remaining active party and the litigation stay remains in place for Lupin (Lupin LTD and Lupin Pharmaceuticals, Inc.).