Scilex Holding Company Announces Final Court Approval of a Settlement Agreement with Takeda Pharmaceuticals to Resolve the Paragraph IV Patent Infringement Lawsuit Relating to Scilex’s intent to Expand the Label for its FDA-Approved Liquid Colchicine Prod

PALO ALTO, Calif., May 14, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that the 45-day review period for the U.S. Federal Trade Commission and U.S. Department of Justice to comment on or object to the Settlement Agreement (the “Settlement Agreement”) entered into by the Company and its wholly owned subsidiary, Scilex Pharmaceuticals Inc. (“Scilex Pharma” and, together with the Company, the “Scilex Parties”) with Takeda Pharmaceuticals U.S.A., Inc. and Takeda Pharmaceuticals Company LTD. (collectively “Takeda”) to resolve the Paragraph IV patent infringement lawsuit (the “Action”) that Takeda filed against the Scilex Parties in the federal district court in Delaware in November 2023 has expired and the U.S. District Court for the District of Delaware entered a Consent Judgment on May 3, 2024, approving the Settlement Agreement. The Action arose from Scilex’s filing of a revised label with the FDA seeking to expand the label for its FDA-approved liquid colchicine product, Gloperba, a preventive treatment for gout. As part of the Settlement Agreement, the Scilex Parties entered into a License Agreement with Takeda granting the Company and its affiliates a non-exclusive license to certain patents owned by Takeda. The terms of those agreements are confidential.

Based on that resolution of those ANDA patent issues, Scilex Pharma has now submitted a copy of that Consent Judgment to the FDA and requested that the FDA convert its tentative approval of Scilex Pharma’s proposed label expansion for Gloperba into a final approval of the expanded Gloperba label. With the resolution of this patent issue, Scilex Pharma believes that it has satisfied all requirements for final FDA approval of the expanded Gloperba label.

The expansion of Gloperba label would provide the Company with the ability to utilize dosing flexibility of liquid formulation to address unmet medical needs and provide specific dosing guidance to patients with renal impairment as set out below:

• Patients with mild or moderate renal or hepatic impairment should be considered for dose adjustment.
• For patients with severe renal impairment, the starting dose should be 0.3 mg/day.
• For patients undergoing dialysis, the total recommended dose should be 0.3 mg and be given twice a week.