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Scilex Holding Company Announces New Out-of-Pocket Costs for Commercially Insured Patients

Scilex Holding Company Announces New Out-of-Pocket Costs for Commercially Insured Patients

Scilex控股公司宣布为商业保险患者提供新的自付费用
GlobeNewswire ·  03/21 09:30

PALO ALTO, Calif., March  21, 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 out-of-pocket costs for its product portfolio for commercially insured patients is expected to be capped at $25 monthly, with certain eligible patients paying as low as $0. This applies to the Company's postherpetic neuralgia pain product, ZTlido, migraine product, ELYXYB, and gout flare prophylaxis product, Gloperba, which is expected to launch in the first half of 2024. Scilex has made significant investments to improve patient affordability and access to its products and continues to build on the Company's commitment to provide non-opioid pain management products to patients.

加利福尼亚州帕洛阿尔托,2024年3月21日(GLOBE NEWSWIRE)——专注于收购、开发和商业化用于治疗急慢性疼痛的非阿片类疼痛管理产品的创新型创收公司Scilex控股公司(纳斯达克股票代码:SCLX,“Scilex” 或 “公司”)今天宣布,其商业保险患者的产品组合的自付费用预计将受到限制每月25美元,某些符合条件的患者支付的费用低至0美元。这适用于该公司的带状疱疹后遗神经痛止痛产品ztLido、偏头痛产品ELYXYB和痛风发作预防产品Gloperba,后者预计将于2024年上半年推出。Scilex已进行了大量投资,以提高患者的可负担性和获得其产品的可及性,并将继续在公司向患者提供非阿片类药物疼痛管理产品的承诺基础上再接再厉。

Scilex has been working with its co-pay savings card adjudicators to resolve the recent breakdown of processing of insurance claims by Change Healthcare, following a cyber-attack on Change Healthcare. Scilex is aware of the impact this disruption has had on its patients and customers and has worked diligently to resolve the issue. Starting today, co-pay savings card processing for ZTlido is expected to be restored to normal operations.

在Change Healthcare遭到网络攻击之后,Scilex一直在与其自付储蓄卡裁定人合作,以解决Change Healthcare最近发生的保险索赔处理中断的问题。Scilex意识到这种中断对其患者和客户的影响,并一直在努力解决这个问题。从今天开始,预计ZTLido的自付储蓄卡处理将恢复正常运营。

Scilex believes that high deductibles and copays shouldn't prevent anyone from receiving the medications they need. Scilex co-pay programs is designed to help patients reduce their co-pays and out-of-pocket costs for their medication. Our program partners with various assistance programs to help make a patient's medication affordable.

Scilex认为,高额的免赔额和自付额不应阻止任何人获得所需的药物。Scilex自付计划旨在帮助患者减少自付费用和药物自付费用。我们的计划与各种援助计划合作,以帮助患者负担得起药物。

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

有关 Scilex 控股公司的更多信息,请参阅 www.scilexholding.com

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

有关 zTLido® 的更多信息,包括完整的处方信息,请参阅 www.ztlido.com

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

有关 ELYXYB® 的更多信息,包括完整的处方信息,请参阅 www.elyxyb.com

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

有关 Gloperba® 的更多信息,包括完整的处方信息,请参阅 www.gloperba.com

About Scilex Holding Company

关于 Scilex 控股公司

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.

Scilex Holding Company是一家创新的创收公司,专注于收购、开发和商业化用于治疗急性和慢性疼痛的非阿片类疼痛管理产品。Scilex以非阿片类药物治疗急慢性疼痛患者的适应症为目标,致力于改善和改善患者预后,以未得到满足的高需求和巨大的市场机会为目标。Scilex的商业产品包括:(i)ztLido(利多卡因局部用药系统)1.8%,这是一种经美国食品药品监督管理局(“FDA”)批准的处方利多卡因局部用药物,用于缓解与带状疱疹后神经痛相关的神经病理性疼痛;(ii)ELYXYB,一种潜在的一线治疗方法和只有经美国食品药品管理局批准的用于急性治疗成人偏头痛的即用型口服溶液,无论有无先兆;以及(iii)Gloperba,抗痛风药物秋水仙碱的第一个也是唯一的液体口服版本适用于预防成人痛风发作,预计将于2024年上半年推出。

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) 5.4%, ("SP-103"), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) ("SP-104"), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022 and a Phase 2 clinical trial is expected to commence in 2024.

此外,Scilex还有三种候选产品:(i)SP-102(10 mg,地塞米松磷酸钠粘性凝胶)(“SEMDEXA” 或 “SP-102”),这是一种广泛用于硬膜外注射的皮质类固醇的新型粘性凝胶制剂,用于治疗腰骶神经根痛或坐骨神经痛,Scilex已经完成了3期研究,已于2017年获得美国食品药品管理局的Fast Track地位;(ii)SP-103(利多卡因外用系统)5.4%(“SP-103”),ZTLido的下一代三强度配方,用于治疗慢性颈部疼痛,Scilex最近已将其用于治疗慢性颈部疼痛完成了腰痛的二期试验。SP-103 已获得美国食品药品管理局在腰痛方面的快速通道地位;以及 (iii) SP-104(4.5 mg,低剂量盐酸纳曲酮延迟释放胶囊)(“SP-104”),一种用于治疗纤维肌痛的新型低剂量延迟释放盐酸纳曲酮,其1期试验已于2022年第二季度完成,2期临床试验预计将于2024年开始。

Scilex Holding Company is headquartered in Palo Alto, California.

Scilex 控股公司总部位于加利福尼亚州帕洛阿尔托。

Forward-Looking Statements

前瞻性陈述

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 the expected out-of-pocket costs for commercially insured patients, the expectation that co-pay savings card processing for ZTlido will be restored, Scilex's expectation to launch Gloperba in the first half of 2024 and plans to initiate a Phase 2 clinical trial in 2024 for SP-104.

根据1995年《私人证券诉讼改革法》第21E条的安全港条款,本新闻稿以及就本新闻稿中讨论的事项在任何演讲或会议期间发表的任何声明均包含与Scilex及其子公司相关的前瞻性陈述,并受风险和不确定性的影响,可能导致实际业绩与预期存在重大差异。前瞻性陈述包括有关商业保险患者的预期自付费用、恢复ZTLido自付储蓄卡处理的预期、Scilex预计将在2024年上半年推出Gloperba以及计划在2024年启动针对SP-104 的2期临床试验的陈述。

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, 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.

可能导致Scilex的实际业绩与我们的前瞻性陈述中表达的业绩存在重大不利差异的风险和不确定性包括但不限于:与交易市场的不可预测性相关的风险以及是否会为Scilex的普通股建立市场;总体经济、政治和商业状况;与 COVID-19(和其他类似干扰)相关的风险;Scilex开发的潜在候选产品可能无法通过临床进展的风险需要开发或接收监管部门在预期的时间表内或完全获得批准;与Scilex候选产品的监管路径不确定性相关的风险;Scilex无法成功推销其候选产品或获得市场认可的风险;Scilex的候选产品可能对患者没有好处或成功商业化的风险;Scilex高估了目标患者群体的规模、他们尝试新疗法的意愿的风险医生愿意开这些疗法;风险SP-102、SP-103 或 SP-104 的试验和研究结果可能不成功或反映出积极的结果;SP-102(SEMDEXA)、SP-103 或 SP-104 的临床和研究者发起的先前试验结果可能无法复制的风险;监管和知识产权风险;以及不时显示的其他风险和不确定性以及Scilex向美国证券交易委员会提交的最新定期报告(包括Scilex的年度报告)中描述的其他风险截至2023年12月31日止年度的10-K表报告,包括这些文件中列出的风险因素.提醒投资者不要过分依赖这些前瞻性陈述,这些陈述仅代表截至本新闻稿发布之日,除非法律要求,否则Scilex没有义务更新本新闻稿中的任何前瞻性陈述。

Contacts:

联系人:

Investors and Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (650) 516-4310

投资者和媒体
Scilex 控股公司
圣安东尼奥路 960 号
加利福尼亚州帕洛阿尔托 94303
办公室:(650) 516-4310

Email: investorrelations@scilexholding.com

电子邮件:investorrelations@scilexholding.com

Website:

网站:

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.

SEMDEXA(SP-102)是Scilex Holding Company的全资子公司Semnur Pharmicals, Inc. 拥有的商标。美国食品和药物管理局计划对专有名称进行审查。

ZTlido is a registered trademark owned by Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex Holding Company.

ztLido是Scilex Holding Company的全资子公司Scilex Pharmicals Inc. 拥有的注册商标。

Gloperba is the subject of an exclusive, transferable license to use the registered trademark by Scilex Holding Company.

Gloperba 获得 Scilex Holding Company 独家、可转让的使用注册商标的许可。

ELYXYB is a registered trademark owned by Scilex Holding Company.

ELYXYB 是 Scilex 控股公司拥有的注册商标。

All other trademarks are the property of their respective owners.

所有其他商标均为其各自所有者的财产。

2024 Scilex Holding Company All Rights Reserved.

2024 Scilex 控股公司版权所有

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