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.
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