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 Product, Gloperba®
Scilex Holding Company (Nasdaq: SCLX) announced final court approval of a settlement agreement with Takeda Pharmaceuticals, resolving a patent infringement lawsuit related to Scilex's intention to expand the label for its liquid colchicine product, Gloperba®. The U.S. District Court for the District of Delaware approved the settlement, allowing Scilex a non-exclusive license to certain Takeda patents. Following this, Scilex requested the FDA convert its tentative approval of the expanded Gloperba® label to final approval.
The expanded label aims to address unmet medical needs, offering specific dosing guidance for patients with renal impairment. Market research shows high interest among rheumatologists for Gloperba®'s precision dosing capabilities. The expanded label would provide dosing flexibility and personalized adjustment options for patients, aligning with American College of Rheumatology guidelines.
- Final court approval of settlement with Takeda Pharmaceuticals.
- Resolution of Paragraph IV patent infringement lawsuit.
- Non-exclusive license to certain Takeda patents.
- Submission to FDA for final label expansion approval.
- High interest from rheumatologists for Gloperba®'s precision dosing.
- Expanded label provides specific dosing for renal impairment.
- Alignment with American College of Rheumatology guidelines.
- Details of the settlement agreement with Takeda remain confidential.
- Uncertainty until FDA grants final approval for expanded label.
- Potential market competition despite non-exclusive license.
Insights
The resolution of the Paragraph IV patent infringement lawsuit between Scilex and Takeda is a significant event. Legal disputes over drug patents can delay product launches and add considerable costs to companies. With the court's approval of the Settlement Agreement, Scilex can now proceed with their expanded label for Gloperba®. This settlement likely includes a non-exclusive license allowing Scilex to use certain Takeda patents, which could facilitate market entry and reduce potential future litigation. It's important to note that the terms of the agreement are confidential, which means investors should stay alert for any disclosed financial implications in future filings. The legal clearance also positively impacts the company's regulatory timeline, potentially accelerating Gloperba®'s market availability and the associated revenue stream.
The final court approval of the Settlement Agreement has positive financial implications for Scilex. The resolution of a patent lawsuit removes a significant uncertainty that might have affected the company's valuation and investor sentiment. With the regulatory pathway now clearer, Scilex can focus on the commercial aspects of Gloperba®'s expanded label. This could lead to increased market penetration, especially given the product's unique position in precision dosing for gout patients with renal impairments. The potential for increased revenue generation from this niche market could enhance the company's profitability. Investors should monitor upcoming quarterly earnings reports for any revenue uplift attributed to Gloperba® and assess the scaling potential of this product in the broader market.
The expanded label for Gloperba® addresses an unmet medical need for gout patients requiring precise dosing. Renal impairment complicates colchicine dosing due to concerns about toxicity and a liquid formulation offering tailored dosing represents a valuable option in this context. The endorsement from rheumatologists and alignment with the American College of Rheumatology (ACR) guidelines further bolster the case for Gloperba®'s clinical utility. This innovation not only improves patient outcomes but also differentiates Scilex’s product in a competitive market. The ability to offer specific dosing guidance for patients with different levels of renal impairment can lead to better treatment adherence and efficacy, positioning Gloperba® favorably against traditional tablets/capsules.
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.
A recent market research study conducted by the Company among rheumatologists revealed a high degree of interest in Gloperba® as a liquid colchicine formulation designed for precision dosing.1 Specifically, clinicians using colchicine for prophylaxis of gout flares in adults indicated a strong likelihood to use Gloperba® instead of tablets/capsules in certain at-risk patient populations who have a clinical need for lowered precision dosing to mitigate the risk of colchicine toxicity. Notably, the American College of Rheumatology (ACR) guidelines also reflect this need.2
“Colchicine in a form that allows incremental dose adjustment would not only more easily permit patient adherence with the American College of Rheumatology (ACR) Guideline for the Management of Gout, but also allow personalized adjustment for patients who do not tolerate their defined dose or might benefit from incremental adjustments of dose up or down,” said Michael Pillinger, MD, NYU Langone Health, New York, NY.
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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 whether the FDA chooses to convert its tentative approval of Scilex Pharma’s proposed label expansion for Gloperba® into a final approval, Scilex’s belief that it has satisfied all requirements for final FDA approval of the expanded Gloperba® label, the potential of Gloperba® label’s expansion to provide Scilex with the ability to utilize dosing flexibility, estimates for potential demand for Gloperba®, the belief that Scilex is well-positioned to market and distribute Gloperba®, 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.
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, 2023 and any 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:
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Email: investorrelations@scilexholding.com
Website: www.scilexholding.com
Reference:
1) Scilex market research study of US rheumatologists, Nov-Dec 2023
2) Khanna D, et al. 2012 American College of Rheumatology Guidelines for Management of Gout. Part 2: Therapy and Anti-inflammatory Prophylaxis of Acute Gouty Arthritis. Arthritis Care & Research. Vol. 64, No. 10, October 2012, pp 1447–1461
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.
FAQ
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