Colchicine

PALO ALTO, Calif., June 20, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “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 in anticipation of selling our commercially available products to new and current special customers, Scilex has entered into a non-exclusive distribution agreement with a well-known and highly respected distributor with over 10 years of sales excellence, Endeavor Distribution LLC. (“Endeavor”). Endeavor has logistics expertise to sell and distribute our currently marketed non-opioid products nationally. Endeavor is an Oklahoma-owned and operated company committed to top-notch logistics and distribution service. They have been involved in logistics, warehousing, manufacturing, fulfillment center preparation, and customer service for over 10 years and will be leveraging that experience to provide our clients the best pick and pack fulfillment and other warehouse and distribution services. “The commercialization of Scilex’s three non-opioid products continues on schedule and we anticipate growth to accelerate through this year and beyond 2024. Given our accelerated pace of product growth, we are aggressively implementing our strategy of building out additional logistics and distribution for our commercial products. Signing an additional distribution partner at this point sets the stage for a successful and aggressive product launch into specialized point of care customers. We will continue to carefully refine our launch strategy and selectively add distribution partners who serve our shared customers with excellence,” said Jaisim Shah, CEO and President of Scilex. For more information on Scilex Holding Company, refer to www.scilexholding.com For more information on ZTlido® including Full Prescribing Information, refer to www.ztlido.com. For more information on ELYXYB®, including Full Prescribing Information, refer to www.elyxyb.com. For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com. https://www.facebook.com/scilex.pharm https://www.linkedin.com/company/scilex-holding-company/ info@scilexholding.com 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. 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 was 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 been 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. 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 new distributor agreement, the exploration of potential transactions involving Semnur, the expectation that any such transactions would be available and able to be completed, the expectation that any such potential transaction will maximize the value of Semnur and SP-102 for Scilex and its stockholders, Scilex’s expectation that SP-102’s Phase 3 study represents a potential significant improvement in treatment of adult patients with lumbosacral radicular pain (sciatica), statements regarding SP-102 (SEMDEXA™), if approved by the FDA, including the potential market and demand of SP-102 (SEMDEXA™), Scilex’s expectation that SP-102 (SEMDEXA™) would be an important addition to treatment options for patients with lumbosacral radicular pain and Scilex’s development and commercialization plans. 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 Scilex’s ability to engage in any potential transaction involving Semnur and SP-102, including the ability to conduct a spin-off, merger, dividend, reclassification or other similar transaction; 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 subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, 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 MediaScilex Holding Company 960 San Antonio RoadPalo Alto, CA 94303Office: (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 Scilex Holding Company to use the registered trademark. 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.

– Initiative aimed at improving access and outcomes for patients with recurrent pericarditis – – American Heart Association to work with champions at 15 healthcare sites to implement initiative activities and improve care quality – HAMILTON, Bermuda, June 17, 2024 (GLOBE NEWSWIRE) -- Kiniksa Pharmaceuticals, Ltd. (Nasdaq: KNSA) (Kiniksa), a commercial-stage biopharmaceutical company with a pipeline of immune-modulating assets designed to target a spectrum of cardiovascular and autoimmune diseases, today announced its sponsorship of the American Heart Association’s new Addressing Recurrent Pericarditis initiative, a multi-faceted effort to improve quality of care through identification, dissemination, and implementation of best practices for the diagnosis and management of recurrent pericarditis. “We are proud to sponsor the American Heart Association’s Addressing Recurrent Pericarditis initiative. Recurrent pericarditis is a rare, chronic, flaring disease, in which patients are frequently misdiagnosed or undertreated due to a lack of access to expert care. In addition to elevating awareness and knowledge around recurrent pericarditis, this initiative will also help strengthen overall care by working to improve processes for diagnosing, referring, and treating patients,” said John F. Paolini, M.D., Ph.D., FACC, Chief Medical Officer of Kiniksa. “Furthermore, this initiative will facilitate knowledge-sharing across a collaborative network of healthcare providers, with the objective of establishing a clear model to streamline patient access to expert care and improved outcomes nationwide.” Through the Addressing Recurrent Pericarditis initiative, the American Heart Association will establish a learning collaborative of champions at fifteen healthcare sites for recurrent pericarditis care. These champions will analyze patient identification and referral pathways, seeking to identify gaps and pragmatic solutions. The ultimate goal of the initiative is to improve outcomes and quality of life for recurrent pericarditis patients by disseminating best practices through national education, model sharing, abstract development, and patient- and physician-targeted podcasts and webinars. “Recurrent pericarditis symptoms can have significant impact on emotional health and quality of life, but they often go undiagnosed and untreated,” said Mariell Jessup, M.D., FAHA, Chief Science and Medical Officer of the American Heart Association. “This new initiative will share insights and best practices nationally to improve identification and treatment for patients with this disease.” Participating sites in the learning collaborative include: Ascension St. Thomas Heart (Nashville, Tennessee)Bluhm Cardiovascular Institute, Northwestern Medicine (Chicago, Illinois)Brigham & Women’s Hospital (Boston, Massachusetts)Cleveland Clinic (Cleveland, Ohio)Houston Medical Hospital (Houston, Texas)Knight Cardiovascular Institute Cardiology Clinic, Oregon Health & Science University (Portland, Oregon)Massachusetts General Hospital (Boston, Massachusetts)Mayo Clinic – Rochester (Rochester, Minnesota)My Cardiologist/CVAUSA (Miami, Florida)New York University Grossman School of Medicine (New York, New York)Pacific Heart Institute (Santa Monica, California)The Regents of the University of California Irvine (Irvine, California)University of Michigan (Ann Arbor, Michigan)University of Utah Hospital (Salt Lake City, Utah)University of Virginia (Charlottesville, Virginia) About Recurrent PericarditisRecurrent pericarditis is a painful and debilitating chronic autoinflammatory cardiovascular disease marked by inflammation of the pericardium and is often associated with changes in electrical conduction and sometimes buildup of fluid around the heart, called pericardial effusion. Recurrent pericarditis symptoms have an impact on quality of life, limit physical activities, and lead to frequent emergency department visits and hospitalizations. Data shows that approximately 40,000 patients in the U.S. seek and receive treatment for recurrent pericarditis each year. Of that group, approximately 14,000 patients experience two or more recurrences due to persistent underlying disease or inadequate response to conventional therapies, such as nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, and corticosteroids. About KiniksaKiniksa is a commercial-stage biopharmaceutical company focused on discovering, acquiring, developing, and commercializing therapeutic medicines for patients suffering from debilitating diseases with significant unmet medical need. Kiniksa’s immune-modulating assets, ARCALYST, abiprubart, and mavrilimumab, are based on strong biologic rationale or validated mechanisms, target a spectrum of underserved cardiovascular and autoimmune conditions, and offer the potential for differentiation. For more information, please visit www.kiniksa.com. Forward-Looking StatementsThis press release contains forward-looking statements. In some cases, you can identify forward- looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions, although not all forward-looking statements contain these identifying words. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation, statements regarding: the ultimate number of healthcare sites that will participate in the learning collaborative; our belief that the Addressing Recurrent Pericarditis initiative will (a) improve quality of care through identification, dissemination and implementation of best practices for the diagnosis and management of recurrent pericarditis, (b) elevate awareness and knowledge around recurrent pericarditis, (c) strengthen overall care by working to improve processes for diagnosing, referring and treating patients, and (d) facilitate knowledge-sharing across a collaborative network of healthcare providers to streamline patient access to expert care and improve outcomes nationwide; that the healthcare champions participating in the Addressing Recurrent Pericarditis initiative will analyze patient identification and referral pathways, seeking to identify gaps and pragmatic solutions with the ultimate goal of improving outcomes, quality of life, identification and treatment for recurrent pericarditis patients by disseminating insights and best practices; and our belief that all of our product candidates offer the potential for differentiation. These forward-looking statements are based on management’s current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our and our partners’ achievements to be materially different from those expressed or implied by the forward-looking statements. These and other important factors discussed in our filings with the U.S. Securities and Exchange Commission, including under the caption “Risk Factors” contained therein, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. Except as required by law, we disclaim any intention or obligation to update or revise any forward-looking statements. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Every Second Counts! ® Kiniksa Investor and Media ContactRachel Frank(339) 970-9437rfrank@kiniksa.com