Scilex Holding Company (“Scilex”), a commercial biopharmaceutical
company focused on developing and commercializing non-opioid
therapies for patients with acute and chronic pain, today announced
that FDA has granted fast track designation for its investigational
drug and device product candidate, SP-103. Scilex is a nearly 100%
(or over 99.9%) majority-owned subsidiary of Sorrento Therapeutics,
Inc. (Nasdaq: SRNE, “Sorrento”).
Scilex is developing SP-103 to be a non-opioid
triple-strength, non-aqueous lidocaine topical system for the
treatment of acute LBP. If approved, SP-103 could become the first
FDA-approved lidocaine topical product for the treatment of acute
LBP. Acute LBP can range in intensity from a dull, constant ache to
a sudden, sharp sensation that leaves the person incapacitated.
According to the CDC in 2020, LBP was the most common type of pain
reported by patients, with 25% of U.S. adults reporting LBP in the
prior 3 months1. LBP is estimated to have a total potential global
market opportunity of approximately $10.0 billion by 2026.2
“We are pleased that the FDA has granted Fast
Track Designation for SP-103,” said Dr. Dmitri Lissin, Chief
Medical Officer of Scilex. “The FDA's decision to place SP-103 in a
category that may enable expedited development and review is an
important milestone for Scilex.”
There are currently no approved pharmaceutical
treatments specifically indicated for the treatment of acute LBP.
The market Scilex intends to address with SP-103, if approved,
includes etiologies that are currently treated with non-procedural
or non-surgical interventions, and where available treatments
provide inadequate pain relief or result in unacceptable adverse
effects. These treatments may include NSAIDs, antidepressants and
opioids, as well as off-label use of lidocaine patches.
“We are very pleased that the FDA has granted
Fast Track designation for the non-opioid SP-103 program, the next
generation triple strength formulation of ZTlido®,” said Jaisim
Shah, President and Chief Executive Officer of Scilex. There are
currently very limited approved treatment options for acute low
back pain, a serious condition the prevalence of which continues to
rise, leaving this affected group with very limited safe and
effective treatment options to date. Receiving this designation
underscores the potential of the ZTlido® platform and the need for
a new therapy like SP-103 that may improve outcomes for those with
this serious debilitating condition.”
The safe and effective treatment of acute LBP
represents high unmet needs and creates a large market opportunity.
LBP is one of the costliest musculoskeletal conditions in
industrialized countries. Experts have estimated that approximately
80% of Americans will experience LBP during their lifetime. The
annual prevalence of LBP is 15% to 45% with a point prevalence of
approximately 30% in the United States. Sixty percent of those who
suffer from acute LBP recover in six weeks and up to 80-90% recover
within 12 weeks. However, the recovery of the remaining patients
with LBP is less certain. LBP accounts for 19% of all workers’
compensation claims in the United States.3 Americans spent at least
$135 billion in 2016 on treating low back and neck pain, which was
the highest expenditure among 154 conditions studied by the
Department of the Institute for Health Metrics and Evaluation at
the University of Washington.4
Scilex’s triple-strength SP-103 is an
investigational, non-aqueous lidocaine topical system undergoing
clinical development in acute LBP conditions. SP-103 builds on the
learnings from Scilex’s FDA-approved product, ZTlido® (topical
lidocaine system) 1.8%, because both products share the same
adhesive drug delivery formulation and manufacturing technology.
Scilex believes that, if approved, SP-103 could become the first
FDA-approved lidocaine topical product for acute LBP indications.
All current uses of topical lidocaine products for acute LBP are
off-label. SP-103 has three times the drug load of ZTlido® (108 mg
versus 36 mg) in the same adhesive system to potentially deliver a
three-fold level of the drug within a targeted area, but retaining
the convenience of a single topical system. Additionally, SP-103 is
designed to deliver a localized dose of lidocaine that is three
times greater than any lidocaine topical product that Scilex is
aware of either on the market or in development. Scilex believes
that, if approved, SP-103 may be able to address the limitations of
prescription lidocaine patches in treating acute LBP by delivering
a higher dose of lidocaine to the application site. As part of the
lifecycle management, Scilex will also target localized
musculoskeletal pain, acute and chronic pain conditions, and
post-operation pain management, to focus on developing and
commercializing non-opioid therapies for patients with acute and
chronic pain. Scilex expects to complete its current Phase 2 trial
of SP-103, randomized, double-blind, placebo controlled, parallel
group, multicenter study to evaluate the safety and efficacy in
subjects with acute lower back pain (LBP) in 10 U.S. sites, in
Q1-2023. The outcome should enable planning of subsequent Phase 3
trial(s). ClinicalTrials.gov link: Safety and Efficacy of SP-103 in
Subjects With Moderate to Severe Acute Lower Back Pain - Full Text
View - ClinicalTrials.gov
Under Section 561A(f)(2) of the United States
Federal Food, Drug, and Cosmetic Act, Scilex is required to make
our expanded access policy for SP-103 (lidocaine topical system)
5.4% publicly available by September 10, 2022 (within 15 days of
the signature date of the FDA Fast Track letter).
Scilex Holding Company and Vickers Vantage Corp.
I (Nasdaq: VCKA) (“Vickers”), a special purpose acquisition company
sponsored by Vickers Venture Fund VI Pte Ltd and Vickers Venture
Fund VI (Plan) Pte Ltd, have entered into a definitive business
combination agreement ("BCA") on March 17, 2022. Upon the closing
of the transaction, the combined company (the “Combined Company”)
will be renamed Scilex Holding Company, and its common stock and
warrants to purchase common stock are expected to be listed on
Nasdaq under the ticker symbol “SCLX” and “SCLXW”, respectively.
The boards of directors of each of Vickers, Scilex and Sorrento
have unanimously approved the proposed transaction. The closing of
the transaction, which is expected to occur in the third quarter or
early fourth quarter of 2022, is subject to the approval of
Vickers’s and Scilex’s shareholders and the satisfaction or waiver
of certain other customary closing conditions.
About Scilex Holding Company
Scilex Holding Company, a nearly 100% (or over
99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc., is
an innovative revenue-generating company focused on acquiring,
developing and commercialization of non-opioid pain management
products for treatment of acute and chronic pain. Scilex is
uncompromising in its focus to become the global pain management
leader committed to social, environmental, economic, and ethical
principles to responsibly develop pharmaceutical products to
maximize quality of life. Results from the Phase III Pivotal Trial
C.L.E.A.R. Program for SEMDEXA™, its novel, non-opioid product for
the treatment of lumbosacral radicular pain (sciatica), were
announced in March 2022. Scilex targets indications with high unmet
needs and large market opportunities with non-opioid therapies for
the treatment of patients with moderate to severe pain.
Scilex launched its first commercial product in October 2018,
in-licensed a commercial product in June 2022, and is developing
its late-stage pipeline, which includes a pivotal Phase 3 candidate
and one Phase 2 and one Phase 1 candidate. Its commercial product,
ZTlido® (lidocaine topical system) 1.8%, or ZTlido®, is a
prescription lidocaine topical product approved by the U.S. Food
and Drug Administration for the relief of pain associated with
postherpetic neuralgia, which is a form of post-shingles nerve
pain. Scilex in-licensed the exclusive right to commercialize
Gloperba® (colchicine USP) oral solution, an FDA-approved
prophylactic treatment for painful gout flares in adults, in the
U.S. Scilex is planning to commercialize Gloperba® beginning in the
first half of 2023 and is well-positioned to market and distribute
the product. Scilex’s three product candidates are SP-102
(injectable dexamethasone sodium phosphate viscous gel product
containing 10 mg dexamethasone), or SEMDEXA™, a Phase 3, novel,
viscous gel formulation of a widely used corticosteroid for
epidural injections to treat lumbosacral radicular pain, or
sciatica, with FDA Fast Track status; SP-103 (lidocaine topical
system) 5.4%, a Phase 2, triple-strength formulation of ZTlido®,
for the treatment of low back pain, with FDA Fast Track status; and
SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone
Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain,
fibromyalgia in multiple Phase 1 programs expected to be initiated
this year. For further information regarding the SP-102 Phase 3
efficacy trial, see NCT identifier NCT03372161
– Corticosteroid Lumbar Epidural Analgesia for Radiculopathy –
Full Text View – ClinicalTrials.gov.
Scilex Holding Company is headquartered in Palo
Alto, California, with operations in both Palo Alto and San Diego,
California. For further information please visit
www.scilexholding.com.
About Sorrento Therapeutics
Sorrento is a clinical and commercial stage
biopharmaceutical company developing new therapies to treat cancer,
pain (non-opioid treatments), autoimmune disease and COVID-19.
Sorrento’s multimodal, multipronged approach to fighting cancer is
made possible by its extensive immuno-oncology platforms, including
key assets such as next-generation tyrosine kinase inhibitors
(“TKIs”), fully human antibodies (“G-MAB™ library”),
immuno-cellular therapies (“DAR-T™”), antibody-drug conjugates
(“ADCs”), and oncolytic virus (“Seprehvec™”). Sorrento is also
developing potential antiviral therapies and vaccines against
coronaviruses, including STI-1558, COVISHIELD™ and COVIDROPS™; and
diagnostic test solutions, including COVIMARK™.
Sorrento’s commitment to life-enhancing
therapies for patients is also demonstrated by our effort to
advance (TRPV1 agonist) non-opioid pain management small molecule,
resiniferatoxin (“RTX”), and SP-102 (10 mg, dexamethasone sodium
phosphate viscous gel) (SEMDEXA™), a novel, viscous gel formulation
of a widely used corticosteroid for epidural injections to treat
lumbosacral radicular pain, or sciatica, and to commercialize
ZTlido® (lidocaine topical system) 1.8% for the treatment of
postherpetic neuralgia (PHN). RTX has been cleared for a Phase II
trial for intractable pain associated with cancer and a Phase II
trial in osteoarthritis patients. Positive final results from the
Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its novel,
non-opioid product for the treatment of lumbosacral radicular pain
(sciatica), were announced in March 2022. ZTlido® was approved by
the FDA on February 28, 2018.
For more information
visit www.sorrentotherapeutics.com
About Vickers Vantage Corp.
I
Vickers Vantage Corp. I is a blank check company
formed for the purpose of effecting a merger, share exchange, asset
acquisition, share purchase, reorganization or similar business
combination with one or more businesses or entities.
Important Information for Investors and
Stockholders
This press release relates to a proposed
transaction between Scilex and Vickers. This press release does not
constitute an offer to sell or exchange, or the solicitation of an
offer to buy or exchange, any securities, nor shall there be any
sale of securities in any jurisdiction in which such offer, sale or
exchange would be unlawful prior to registration or qualification
under the securities laws of any such jurisdiction. In connection
with the transaction described herein, Vickers has filed a
Registration Statement on Form S-4 (the “Registration Statement”),
which includes a document that serves as a prospectus and proxy
statement of Vickers, referred to as the proxy
statement/prospectus. After the Registration Statement is declared
effective by the SEC, the proxy statement/prospectus will be sent
to all Vickers shareholders as of a record date for the meeting of
Vickers shareholders to be established for voting on the proposed
business combination. Vickers will also file other documents
regarding the proposed transaction with the SEC. This press release
does not contain all of the information that will be contained in
the proxy statement/prospectus or other documents filed or to be
filed with the SEC. Investors and security holders of
Vickers are urged to read these materials (including any amendments
or supplements thereto) and any other relevant documents in
connection with the transaction that Vickers files with the SEC
when, and if, they become available because they will contain
important information about Vickers, Scilex and the proposed
transaction. Investors and security holders will be
able to obtain free copies of the Registration Statement, the proxy
statement/prospectus and all other relevant documents filed or that
will be filed with the SEC by Vickers through the website
maintained by the SEC at www.sec.gov.
Participants in the
Solicitation
Vickers and its directors and executive officers
may be deemed participants in the solicitation of proxies from
Vickers’s shareholders in connection with the transaction. A list
of the names of such directors and executive officers and
information regarding their interests in the proposed business
combination will be contained in the proxy statement/prospectus
when available. You may obtain free copies of these documents as
described in the preceding paragraph.
Scilex and its directors and executive officers
may also be deemed to be participants in the solicitation of
proxies from the shareholders of Vickers in connection with the
proposed transaction. Information about Scilex’s directors and
executive officers and information regarding their interests in the
proposed transaction will be included in the proxy
statement/prospectus for the proposed transaction.
Non-Solicitation
This press release is not a proxy statement or
solicitation of a proxy, consent or authorization with respect to
any securities or in respect of the potential transaction and shall
not constitute an offer to sell or a solicitation of an offer to
buy the securities of Vickers, the Combined Company or Scilex, nor
shall there be any sale of any such securities in any state or
jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of such state or jurisdiction. No offer of
securities shall be made except by means of a prospectus meeting
the requirements of the Securities Act of 1933, as amended.
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 Vickers, Sorrento and its subsidiaries, including but
not limited to Scilex, 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 any potential benefits of
the Fast Track Designation for SP-103, the total potential global
market opportunity for LBP, the ability of SP-103 to address
limitations of prescription lidocaine patches in treating acute
LBP, Scilex’s expected timeline to complete the Phase 2 trial for
SP-103, the proposed business combination between Scilex and
Vickers, including the timing of such business combination, the
potential listing of the Combined Company’s common stock and
warrants to purchase common stock on Nasdaq or other major
securities exchange and the anticipated stock ticker symbol for
such shares and warrants to purchase common stock, the expectation
that Vickers will file subsequent amendments to the Registration
Statement on Form S-4, the estimated or anticipated future
results and benefits of the Combined Company following the proposed
business combination, including the likelihood and ability of the
parties to successfully consummate the proposed business
combination, future opportunities for the Combined Company, the
timing of the completion of the proposed business combination,
Scilex’s and the Combined Company’s proposed business strategies,
the expected cash resources of the Combined Company and the
expected uses thereof; Scilex’s and the Combined Company’s current
and prospective product candidates, planned clinical trials and
preclinical activities and potential product approvals, as well as
the potential for market acceptance of any approved products and
the related market opportunity; statements regarding SP-102
(SEMDEXA™), SP-103 or SP-104, if approved by the FDA; Scilex’s
development and commercialization plans; and Sorrento’s products,
technologies and prospects and Scilex’s products, technologies and
prospects. Risks and uncertainties that could cause
Sorrento’s and Scilex’s actual results to differ materially and
adversely from those expressed in our forward-looking statements,
include, but are not limited to: the inability of the parties to
consummate the proposed business combination transaction for any
reason or the occurrence of any event, change or other
circumstances that could give rise to the termination of the BCA,
including any failure to meet applicable closing conditions;
changes in the structure, timing and completion of the proposed
transaction between Vickers and Scilex; Vickers’s ability to
continue its listing on the Nasdaq Capital Market until closing of
the proposed transaction; the Combined Company’s ability to list
its securities on Nasdaq or other major securities exchange after
closing of the proposed transaction; the ability of the parties to
achieve the benefits of the proposed transaction, including future
financial and operating results of the Combined Company; the
ability of the parties to realize the expected synergies from the
proposed transaction; risks related to the outcome of any legal
proceedings that may be instituted against the parties following
the announcement of the proposed business combination; general
economic, political and business conditions; risks related to the
ongoing COVID-19 pandemic; 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 results of the Phase 2 trial for SP-103
or Phase 1 trials for SP-104 may not be successful; risks that the
prior results of the clinical trials of SP-102 (SEMDEXA™), SP-103
or SP-104 may not be replicated; regulatory and intellectual
property risks; the risk that any requisite regulatory approvals to
complete the transaction are not obtained, are delayed or are
subject to unanticipated conditions that could adversely affect the
Combined Company or the expected benefits of the proposed
transaction or that the approval of Vickers’s shareholders is not
obtained; the risk of failure to realize the anticipated benefits
of the proposed transaction; the amount of redemption requests made
by Vickers’s shareholders and other risks and uncertainties
indicated from time to time and other risks set forth in Sorrento’s
and Vickers’s filings with the SEC, including in the Registration
Statement. Investors are cautioned not to place undue reliance on
these forward-looking statements, which speak only as of the date
of this release, and we undertake no obligation to update any
forward-looking statement in this press release except as may be
required by law.
Contacts:
For Scilex Holding Company
Jaisim ShahChief Executive OfficerScilex Holding Company 960 San
Antonio RoadPalo Alto, CA 94303Office: (650) 516-4310Email:
jshah@scilexpharma.com
Website: www.sorrentotherapeutics.com and
www.scilexholding.com
Investors and Media Contact:
Contact:
Brian CooleyEmail:
mediarelations@sorrentotherapeutics.comWebsite:
www.sorrentotherapeutics.comFor Vickers Vantage Corp. I
Jeffrey Chi Chief Executive Officer 85 Broad Street, 16th
FloorNew York, NY 10004Phone: (646) 974-8301Email:
jeff.chi@vickersventure.com
Website: www.vickersvantage.com
Investors and Media Contact: Nicolette Ten, Senior Account
Executive, SPRGEmail: nicolette.ten@sprg.com.sg
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, Seprehvec™, SOFUSA™,
COVISHIELD™, COVI-MSC™, and COVIMARK™ are trademarks of Sorrento
Therapeutics, Inc.
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 an exclusive, transferable license
to use the trademark by Scilex Holding Company.
All other trademarks are the property of their
respective owners.
© 2022 Sorrento Therapeutics, Inc. All Rights
Reserved.
Reference
-
https://www.cdc.gov/acute-pain/low-back-pain/index.html
-
https://brandessenceresearch.com/healthcare/lower-back-pain-market-size
-
https://www.medscape.com/answers/1144130-118907/what-is-the-prevalence-of-low-back-pain-lbp
-
https://www.healthdata.org/news-release/low-back-and-neck-pain-tops-us-health-spending
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