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 Colchicine Product, Gloperba®
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The settlement between Scilex and Takeda marks a significant pivot in the ongoing patent litigation landscape within the pharmaceutical industry. Such settlements are common in the sector, reflecting a strategic move to mitigate risks and costs associated with prolonged legal disputes. The license agreement grants Scilex a non-exclusive right to Takeda's patents, which can be interpreted as a positive development for Scilex's ability to market Gloperba without the immediate threat of infringement litigation. It's important to note that the confidentiality of the agreement's terms leaves room for speculation on the financial implications, but it typically includes milestone payments or royalties.
From a legal standpoint, the requirement for approval from the district court, FTC and DOJ underscores the antitrust considerations inherent in pharmaceutical patent settlements, particularly in Paragraph IV cases. These cases involve generic or non-branded drug companies challenging the patents of branded drug companies, often leading to a faster introduction of lower-cost alternatives. The outcome of this regulatory review will be important in determining the settlement's finality and the associated market implications for both Scilex and Takeda.
The announcement of the settlement agreement and subsequent license may have a nuanced impact on the business operations of Scilex. The ability to expand Gloperba's label without impending legal obstacles is a strong positive signal for Scilex's product portfolio diversification and market penetration strategies. Investors may view this development as an opportunity for Scilex to solidify its position in the non-opioid pain management market, which is a growing segment due to the opioid crisis and the subsequent demand for safer alternatives.
Market dynamics suggest that a successful expansion of Gloperba's label can lead to increased revenue streams for Scilex. However, the non-exclusive nature of the license means that Takeda could also license the patents to other companies, potentially increasing competition. Investors should monitor Scilex's execution of its commercial strategy post-settlement and any market reactions to the introduction of new competitors as a result of the non-exclusive licensing agreement.
From a financial perspective, the settlement could be seen as a risk-reduction strategy, potentially avoiding the costs associated with a protracted legal battle. The immediate financial impact on Scilex's balance sheet might be opaque due to the confidential nature of the settlement terms. However, investors should consider the potential long-term financial benefits of this agreement, such as the avoidance of litigation costs and the potential for increased market share and sales revenue from Gloperba.
Investors should also be aware that the settlement could involve upfront payments or ongoing royalties to Takeda, which could affect Scilex's short-term financials. It's essential to assess how this settlement aligns with Scilex's overall financial strategy and its implications for future earnings. Close attention to Scilex's forthcoming financial statements will be key in determining the actual cost of the settlement and its impact on the company's profitability and cash flow.
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)
In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica for which Scilex has completed a Phase 3 study and has granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system)
Scilex Holding Company is headquartered in Palo Alto, California.
Forward-Looking Statements
This press release and any statements made for and during any presentation or meeting concerning the matters discussed in this press release contain forward-looking statements related to Scilex and its subsidiaries under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements regarding estimates for the gout treatment market and affected patient population, estimates for potential demand for Gloperba®, estimates for the launch pricing of Gloperba®, the belief that Scilex is well-positioned to market and distribute Gloperba®, Scilex’s expectations for Gloperba® to be the first liquid oral version of colchicine formulation allowing providers to prescribe precision dosing, Scilex’s expectations for Gloperba® to last more than 30 days in patients who are treated with doses lower than 0.6 mg, Scilex’s expectation to launch Gloperba® in the first half of 2024 , each parties’ releases of claims arising from the captioned patent infringement lawsuit, the granting of the non-exclusive license and FDA’s approval for the modification of the Gloperba® label and plans to initiate a Phase 2 clinical trial in 2024 for SP-104.
Risks and uncertainties that could cause Scilex’s actual results to differ materially and adversely from those expressed in our forward-looking statements, include, but are not limited to: risks associated with the unpredictability of trading markets and whether a market will be established for Scilex’s common stock; general economic, political and business conditions; risks related to COVID-19 (and other similar disruptions); the risk that the potential product candidates that Scilex develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; risks relating to uncertainty regarding the regulatory pathway for Scilex’s product candidates; the risk that Scilex will be unable to successfully market or gain market acceptance of its product candidates; the risk that Scilex’s product candidates may not be beneficial to patients or successfully commercialized; the risk that Scilex has overestimated the size of the target patient population, their willingness to try new therapies and the willingness of physicians to prescribe these therapies; risks that the outcome of the trials and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not be replicated; regulatory and intellectual property risks; and other risks and uncertainties indicated from time to time and other risks described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Scilex undertakes no obligation to update any forward-looking statement in this press release except as may be required by law.
Contacts:
Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310
Email: investorrelations@scilexholding.com
Website: www.scilexholding.com
SEMDEXA™ (SP-102) is a trademark owned by Semnur Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding Company. A proprietary name review by the FDA is planned.
ZTlido® is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.
Gloperba® is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.
ELYXYB® is a registered trademark owned by Scilex Holding Company.
All other trademarks are the property of their respective owners.
© 2024 Scilex Holding Company All Rights Reserved.
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