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 a
Master Distributor Agreement with Devart Middle East Food
Supplements (“Devart Middle East”), as Master Distributor, and CH
Trading Group LLC (“CH Trading Group”), as Territories Distributor,
to expand the distribution of ZTlido® into the countries of
Morocco, Tunisia, Libya, Jordan, Iraq, and South Africa
(“Designated Territories”).
The Master Distributor Agreement is an outgrowth
Scilex’s existing Product Distribution Agreement with CH Trading
Group, under which CH Trading Group is continuing the process of
expanding commercialization of ZTlido® in the Middle East and
North/South Africa markets and has the opportunity to distribute
across the broader Islamic world and further expand the
relationship for other products in Scilex’s non-opioid pain
portfolio.
Under the Master Distributor Agreement, Devart
Middle East assumes the responsibility, among other things, of
promoting, marketing, selling and distributing ZTlido®, and
potentially other Scilex products, through a network of business
associates, into the above Designated Territories.
ZTlido® is a lidocaine topical system approved
for the relief of neuropathic pain associated with post-herpetic
neuralgia (PHN). ZTlido® was strategically designed to address the
limitations of current prescription lidocaine patches by providing
significantly improved adhesion and continuous pain relief
throughout the 12-hour administration period.
- Over one
million patients are estimated to have been treated with ZTlido® in
the United States since its launch according to Symphony Health
prescription data.
- ZTlido® is now
the number one prescribed, non-opioid, branded, pain medication by
pain specialists in the United States, based on Symphony Health
prescription data gathered for 2023.
- In the U.S.,
patients report 89% satisfaction with ZTlido®, in a 2023 patient
survey conducted by Scilex (n=100, rating as “completely” or
“mostly” satisfied with ZTlido® treatment).
For more information on Scilex Holding Company, refer to
www.scilexholding.com
For more information on Scilex Holding Company Sustainability
Report, refer to www.scilexholding.com/investors/sustainability
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.
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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.
In addition, Scilex has three product
candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate
viscous gel) (“SEMDEXATM” 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.
About CH Trading Group
CH Trading Group LLC is part of the CH Group
family of companies. CH Group constitutes a diversified
conglomerate targeting eight economic” Sectors”: healthcare,
pharmaceuticals, food, finance, cosmetics, tourism, fashion,
media/entertainment. Spanning a variety of multi-national products,
services and solutions, its world mission involves connecting,
developing, and promoting, from Local to Global™ and throughout the
world, all aspects of a wholesome, healthy, and productive
lifestyle.
CH Trading Group focuses on international
import/export and trade, prioritizing the countries of the
Organization of Islamic Cooperation (OIC), as well as the Middle
East and North Africa (MENA) and Gulf Cooperation Council (GCC)
Regions. It has responded to worldwide demands for identifying and
securing supply chains by introducing innovative products,
including from the US, and developing a robust distribution network
for goods.
For more information, please visit
https://chgroupus.com/
About Devart Middle East
Devart Middle East Food Supplements is part of
the DevartLab Group family, headquartered in Egypt. Devartlab Group
consists of investors and enterprising visionaries focusing on
three pivotal areas: pharmaceuticals, non-banking microfinance and
cutting-edge digital solutions, across various Islamic Markets and
beyond into the European and US markets. Its diverse expertise
includes healthcare, technology, B2C finance, business innovation,
manufacturing, promotion, marketing, sales and distribution.
For more information, please visit:
https://devartlab.com/en
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
the Company’s preliminary unaudited financial results for the month
ended July 31, 2024, the Company’s outlook, goals and expectations
for 2024, and the Company’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 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.
Scilex (NASDAQ:SCLX)
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Scilex (NASDAQ:SCLX)
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から 8 2023 まで 8 2024