Scilex Holding Company (“Scilex”), a Sorrento Company (nearly 100%
or over 99.9% majority-owned subsidiary of Sorrento Therapeutics,
Inc.) (Nasdaq: SRNE, “Sorrento”) and a commercial biopharmaceutical
company focused on developing and commercializing non-opioid
therapies for patients with acute and chronic pain, announced
dosing of the first subject in a Phase 2, randomized, double-blind,
placebo-controlled, parallel group, multicenter study to evaluate
the safety and efficacy of SP-103 in subjects with acute LBP.
“It is a significant milestone for Scilex to begin the next
development phase of the triple-dose strength of FDA-approved
ZTlido® (lidocaine topical system) 1.8% (“ZTlido®”). Most of the
off-label use of topical lidocaine products is for the treatment of
LBP. However, the low dosage strength of existing lidocaine
products does not always provide sufficient pain relief3. A higher
concentration of lidocaine per given area of a patch may lead to
better efficacy and provide evidence for registering SP-103 for the
treatment of acute LBP in patients with mostly superficial muscular
pain. Based on the favorable data from the pharmacokinetics study,
Scilex is advancing this program into Phase 2 with initiation of
the study in LBP patients,” said Dr. Dmitri Lissin, Chief Medical
Officer of Scilex.
“It is exciting to see a product in development with a higher
concentration of lidocaine and great adhesion qualities. This
product may greatly help patients with muscular pain in the lower
back, and may also help to avoid use of systemic medications,
associated with systemic side effects, including opioids,” said
Alan Miller, M.D., Director of Interventional Pain Management at
Coastal Spine & Pain Center, Fernandina Beach, Florida.
Scilex’s current marketed product, ZTlido (lidocaine topical
system), has label claims regarding superior adhesion qualities as
compared to other products and SP-103 has the same adhesion
characteristics.
“SP-103 has the potential to meet our core goal of developing
best-in-class pain management therapies to significantly improve
the lives of patients with LBP who are seeking new effective
treatments. Scilex is excited about this potentially safe and
effective treatment without the limitations of currently used
off-label therapies, including opioids with risks of abuse and
addiction. ZTlido is already approved for use of up to 3 patches at
once with proven safety. We believe that one SP-103 patch with the
same systemic exposure to lidocaine may have a good probability of
efficacy in this indication with a very low risk for safety
concerns,” said Jaisim Shah, Chief Executive Officer of Scilex.
Scilex is developing SP-103 to be a triple-strength, non-aqueous
lidocaine topical system 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. It is
estimated that approximately 65 million adults in the U.S., or 25%
of U.S. adults, suffer from acute back pain1 with a total potential
global market opportunity of approximately $10.0 billion by
2026.
There are currently no approved non-NSAID (non-steroidal
anti-inflammatory drugs) pharmaceutical treatments specifically
indicated for the treatment of acute LBP. The market we intend 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.
The safe and effective treatment of acute LBP represents high
unmet needs and creates a large market opportunity. LBP is one of
the costliest benign 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 weeks2.
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. 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.
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 ZTlido because both products share the same adhesive drug
delivery formulation and manufacturing technology. If approved, we
believe that SP-103 could become the first-in-class 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 threefold the level of
the drug within a targeted area, still with 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 we are aware of either on the market
or in development. If approved, we believe 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 this trial
in one year. The outcome should enable planning of subsequent phase
3 trial(s).
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, 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 by the third quarter of 2022, is subject
to the approval of Vickers’s shareholders and the satisfaction or
waiver of certain other customary closing conditions.
A corporate presentation describing Scilex's development plans
can be found at www.scilexholding.com.
About Scilex Holding Company
Scilex Holding Company, a nearly 100% (or over
99.9%) majority-owned subsidiary of Sorrento Therapeutics, Inc., is
dedicated to the development 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. Highly positive 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 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’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; 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, Inc.
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 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 Abivertinib, COVISHIELD™ and COVI-MSC™;
and diagnostic test solutions, including COVIMARK™.
Sorrento's commitment to life-enhancing
therapies for patients is also demonstrated by our effort to
advance a first-in-class (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 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 the efficacy and safety
profile of SP-103 for treatment of LBP in patients, the ability of
SP-103 to address limitations of prescription lidocaine patches in
treating acute LBP, the number of patients to be enrolled in this
Phase 2 study, Scilex’s expected timeline to complete this Phase 2
study and plans for subsequent phase 3 trial(s), 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 with the SEC, 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, including the potential for Scilex’s product candidates
to be best-in-class or first-in-class therapies. 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 may not be successful; risks that the prior
results of the clinical trials of SP-102 (SEMDEXA™) or SP-103 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 CooleySenior Vice PresidentCorporate
Communications and Investor RelationshipsHead of Lymphatic Drug
DeliveryEmail: mediarelations@sorrentotherapeutics.comWebsite:
www.sorrentotherapeutics.com
For 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.
All other trademarks are the property of their
respective owners.
© 2022 Sorrento Therapeutics, Inc. All Rights
Reserved.
References
- https://www.cdc.gov/acute-pain/low-back-pain/index.html
-
https://www.medscape.com/answers/1144130-118907/what-is-the-prevalence-of-low-back-pain-lbp
- The Efficacy, Effectiveness and Safety of 5% Transdermal
Lidocaine Patch for Chronic Low Back Pain: A Narrative Review.
Santana JA, et al. PM&R. 2020. PMID: 32189475 Review.Options in
topical therapies in the management of patients with acute
pain.McCarberg B, D'Arcy Y. Postgrad Med. 2013 Jul;125(4 Suppl
1):19-24. PMID: 24547600 Review.Lidocaine patch treatment in
patients with low back pain: results of an open-label,
nonrandomized pilot study. Gimbel J, Linn R, Hale M, Nicholson B.
Am J Ther. 2005 Jul-Aug;12(4):311-9. doi: PMID: 16041194
- Cost-effectiveness Of Treatments for Low Back Pain:
https://www.practicalpainmanagement.com/pain/spine/cost-effectiveness-treatments-low-back-pain
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