Scilex Holding Company Announces a Settlement Agreement with Takeda Pharmaceuticals to Resolve the Paragraph IV Patent Infringement Lawsuit Relating to Scilex’s Filing of a sNDA with the FDA Seeking to Expand the Label for its FDA-Approved Liquid Colchici

PALO ALTO, Calif., March 20, 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 Company and its wholly owned subsidiary, Scilex Pharmaceuticals Inc. (“Scilex Pharma”, together with the Company, the “Scilex Parties”), have entered into a Settlement Agreement (the “Settlement Agreement”) with Takeda Pharmaceuticals U.S.A., Inc. and Takeda Pharmaceuticals Company LTD. (collectively “Takeda”) to resolve the Paragraph IV patent infringement lawsuit that Takeda filed against the Scilex Parties in federal district court in Delaware in November 2023. That litigation arose from Scilex’s filing of a sNDA 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. The Settlement Agreement is subject to approval by the district court, and by both the Federal Trade Commission and the U.S. Department of Justice, as is required in Paragraph IV patent case settlements.

For more information on Scilex Holding Company, refer to www.scilexholding.com.

For more information on Gloperba, including Full Prescribing Information, refer to www.gloperba.com.

For more information on ELYXYB, including Full Prescribing Information, refer to www.elyxyb.com.

For more information on ZTlido including Full Prescribing Information, refer to www.ztlido.com.

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About Scilex Holding Company

Scilex Holding Company is an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain. Scilex targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes. Scilex’s commercial products include: (i) ZTlido (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB, a potential first-line treatment and the only FDA-approved, ready-to-use oral solution for the acute treatment of migraine, with or without aura, in adults; and (iii) Gloperba, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults, expected to launch in the first half of 2024.