Scilex Holding Company (“Scilex”), a subsidiary of Sorrento
Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”), announced that,
effective September 1, 2022, ZTlido® (lidocaine topical system)
1.8% will be added to one of the largest national PBMs and a
national health plan – thereby expanding coverage to 30 million
lives and Scilex will continue to work with them to access an
additional 20 million lives. ZTlido® is indicated for relief of
pain associated with post-herpetic neuralgia (PHN), also referred
to as post-shingles pain.
“Scilex commercial team continues to demonstrate success in
expanding access and has prioritized and targeted select payor
accounts to further improve the access for ZTlido®,” said Jaisim
Shah, Chief Executive Officer of Scilex Holding Company.
However, not all lidocaine patch products are created equal.
ZTlido® 1.8% uses proprietary ZTech advanced technology to provide
9x greater bioavailability versus 5% lidocaine patches and superior
adhesion proven in head-to-head studies, and while showering,
bathing or exercising.1-6 This ensures that pain relief is
delivered for the full treatment duration, without interrupting a
patient’s routine.
ZTlido® was approved by the U.S. Food and Drug Administration
(FDA) in 2018 for relief of pain associated with PHN in adults.
Side effects of ZTlido® include application site reactions such as,
irritation, erythema, and pruritus.
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
shareholders and the satisfaction or waiver of certain other
customary closing conditions.
About ZTlido® (lidocaine topical system)
1.8%
Indication: ZTlido® is indicated for relief of pain
associated with post-herpetic neuralgia (PHN) in adults.
Important Safety Information
Contraindications: ZTlido® is contraindicated in patients with a
known history of sensitivity to local anesthetics of the amide
type, or to any other component of the product.
Warnings and Precautions: Accidental exposure can occur even
after a ZTlido® patch has been used. Small children or pets could
suffer serious adverse effects from chewing or ingesting a new or
used ZTlido® patch. Store and dispose of patches properly and keep
out of reach of children and pets.
Excessive dosing or overexposure to lidocaine can occur. Longer
duration of application, application of more than the recommended
number of patches, smaller patients, or impaired elimination may
all contribute to increased blood concentration levels of
lidocaine. If lidocaine overdose is suspected, check drug blood
concentration. Management of overdose includes close monitoring,
supportive care, and symptomatic treatment.
Cases of methemoglobinemia have been reported with local
anesthetic use, although patients with glucose-6-phosphate
dehydrogenase deficiency, congenital or idiopathic
methemoglobinemia, cardiac or pulmonary compromise, or concurrent
exposure to oxidizing agents or their metabolites are more
susceptible to developing clinical manifestations of the condition.
Signs and symptoms include cyanotic skin discoloration and/or
abnormal coloration of the blood and may occur immediately or may
be delayed after exposure. Methemoglobin levels may continue to
rise leading to more serious central nervous system and
cardiovascular adverse effects. If this occurs, discontinue ZTlido®
and any other oxidizing agents. Depending on severity of the
symptoms, patients may respond to supportive care or may require
treatment with methylene blue, exchange transfusion, or hyperbaric
oxygen.
Application site reactions can occur during or immediately after
treatment with ZTlido®. This may include development of blisters,
bruising, burning sensation, depigmentation, dermatitis,
discoloration, edema, erythema, exfoliation, irritation, papules,
petechia, pruritus, vesicles, or may be the locus of abnormal
sensation. These reactions are generally mild and transient,
resolving spontaneously within a few minutes to hours. If
application site reactions occur while the topical system is being
worn, advise the patient to remove ZTlido® and not to reapply until
skin reactions subside.
Hypersensitivity cross-reactions may be possible for patients
allergic to PABA derivatives. Manage hypersensitivity reactions by
conventional means.
Eye exposure with ZTlido® should be avoided. If eye contact
occurs, immediately wash out the eye with water or saline and
protect the eye (such as, eyeglasses/eyewear) until sensation
returns.
Adverse Reactions: Side effects of ZTlido® include application
site reactions such as irritation, erythema, and pruritus. These
are not all of the adverse reactions that may occur. Please see
Full Prescribing Information for more information.
Use in Specific Populations: Use of ZTlido® during lactation
should be used with caution as lidocaine is excreted into breast
milk. The limited human data with lidocaine in pregnant woman is
not sufficient to inform drug-associated risk for major birth
defects and miscarriage.
To report SUSPECTED ADVERSE REACTIONS, contact SCILEX
Pharmaceuticals Inc. at 1-866-SCILEX3 or contact FDA at
1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.Less is More:
ZTlido® 1.8% uses proprietary ZTech advanced technology for proven
bioequivalence to 5% lidocaine patch, but with 9x greater
bioavailability.7-9 Data are from studies performed with 5%
lidocaine patch.
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; 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 (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 the Scilex’s goal to reach 250 million to 260
million covered lives, 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.
References:
- LIDODERM® (lidocaine patch 5%) [prescribing information].
Malvern, PA: Endo Pharmaceuticals Inc; 2018.
- Data on file. SCILEX Pharmaceuticals Inc. SCI-LIDO-PK-001.
- Gudin J, Argoff C, Nalamachu s. 1.8% lidocaine patch (ZTlido):
review of a new formulation. Postgrad Med. 2015;127(suppl):
S44-S45.
- Webster L, Mallick-Searle T, Adler JA, Greuber E, Patel K,
Vought K. ZTlido® (lidocaine topical system) 1.8% has superior
adhesion compared to generic Mylan lidocaine patch 5%. Poster
presented at: PAINWeek; September 3-7, 2019; Las Vegas, NV.
- SCILEX Pharmaceuticals Inc. Data on file:
SCI-LIDO-ADH-003.
- SCILEX Pharmaceuticals Inc. Data on file:
SCI-LIDO-ADH-002.
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