Scilex Holding Company (Scilex), a majority-owned subsidiary of
Sorrento Therapeutics, Inc. (Nasdaq: SRNE), announces the
completion of post-merger integration.
Following the merger with Semnur Pharmaceuticals, Inc. in March
2019, and the contribution of Scilex Pharmaceuticals Inc. equity to
Scilex Holding Company, Scilex rapidly proceeded to implement key
changes necessary to ensure the long-term success of the newly
formed company.
- Right-sized corporate management team. New senior executive
team benefits from significant drug commercialization experience.
New focus on operational excellence in support of commercial launch
of ZTlido® (lidocaine topical system) 1.8%.
- Realigned sales territories to maximize growth in high
potential areas. Reduced overall sales related expenses by over 20%
without any expected negative impact to field operation performance
and enabled better targeting of addressable markets. Gross sales in
the past three months have shown strong and sustained
month-over-month growth, increasing from approximately $1 million
in March, to $2.4 million in April and $3.3 million in May,
respectively.
- Reprioritized drug development pipeline. 1) SP-102 phase 3
clinical trial remains on track to be completed by first half of
2020. 2) The 5.4% (3X strength) lidocaine topical system is being
evaluated for a lower back pain indication in an upcoming phase 2
trial expected to start in the second half of 2019.
Jaisim Shah, Chief Executive Officer and President of Scilex,
commented, “We are very pleased with the rapid progress made to
reorient the company to ensure focus on key areas post-merger. We
now have in place the full senior executive team complemented by an
outstanding team of field sales reps and managed care access
managers, who are deeply knowledgeable reimbursement experts.
Leading Global venture capital firms including Canaan
Partners, Frazier Healthcare Partners, and Vivo Capital,
are shareholders in Scilex along with Sorrento and Japan’s Itochu
Corporation, a $100 billion Fortune Global 20 company. With the
ongoing opioid crisis in our nation, Scilex has been in active
dialogues with local, state and federal agencies on best strategies
and methods to treat a continuum of chronic and acute pain
conditions using non-addictive non-opioid therapies. Scilex can
take full advantage of the opportunities created in this paradigm
shift.”
About Sorrento Therapeutics, Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to turn
malignant cancers into manageable and possibly curable diseases.
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”),
clinical stage immuno-cellular therapies (“CAR-T”), intracellular
targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”),
and clinical stage oncolytic virus (“Seprehvir®”).
Sorrento's commitment to life-enhancing therapies for cancer
patients is also demonstrated by our effort to advance
Resiniferatoxin (“RTX”), a first-in-class (TRPV1 agonist)
non-opioid pain management small molecule, ZTlido® and SP-102, a
non-opioid corticosteroid gel. Resiniferatoxin is completing Phase
1b trials in terminal cancer patients and knee osteoarthritis
patients. ZTlido was approved by US FDA on 02/28/18. SP-102 is in
Phase 3 pivotal study for the treatment of lumbar radicular
pain/sciatica. RTX Phase 3 studies in osteoarthritis knee pain are
scheduled to start later in 2019.
For more information visit www.sorrentotherapeutics.com
About Scilex Holding Company
Scilex Holding Company, a majority-owned subsidiary of Sorrento
located in San Diego, California, responsibly develops and brings
branded products to market using technologies designed to maximize
quality of life for the patients we serve. We are uncompromising in
our focus to become the global pharmaceutical leader in non-opioid
pain management through social, environmental, economic and ethical
principles. Dedicated to valued partnerships, we strive to deliver
next-generation products that met patients’ needs. Through Scilex
Pharmaceuticals Inc., our wholly owned subsidiary, our product,
ZTlido® (lidocaine topical system) 1.8%, is a branded lidocaine
topical system formulation for the treatment of relieving the pain
of post-herpetic neuralgia, also referred to as after-shingles
pain. For more information visit www.scilexpharma.com.
About ZTlido® (lidocaine topical system)
1.8%
Indication ZTLIDO is indicated for relief of pain associated
with post-herpetic neuralgia (PHN).
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. 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. Inform
patients of these potential reactions and that severe skin
irritation may occur with ZTLIDO if applied for a longer period
than instructed.
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, eye glasses/eye wear) 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:
https://www.ztlido.com/prescribing-information.pdf
Forward-Looking Statements
This press release and any statements made for and during any
presentation or meeting contains forward-looking statements related
to Sorrento Therapeutics, Inc. and its subsidiaries, including but
not limited to Scilex Pharmaceuticals Inc., Semnur Pharmaceuticals,
Inc. and Scilex Holding Company, 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 developments of
and prospects for SP-102 and ZTlido®; Sorrento's, Scilex Holding
Company, Scilex Pharmaceuticals Inc.’s and Semnur Pharmaceuticals,
Inc.’s products, product candidates and technologies, including its
non-opioid pain products and product candidates; Scilex Holding
Company’s ability to continue to accelerate the development of
SP-102 and 5.4% lidocaine patch for lower back pain; reductions in
sales related expenses and the anticipated impact on field
operation performance; estimated monthly gross sales amounts and
expectations for Sorrento's and its subsidiaries’ technologies and
product candidates and financing prospects. Risks and uncertainties
that could cause our actual results to differ materially and
adversely from those expressed in our forward-looking statements,
include, but are not limited to: risks related to Sorrento's, its
subsidiaries' technologies and prospects; the possibility that
ZTlido® (lidocaine topical system) 1.8% may not be commercially
successful, risks that SP-102 and 5.4% (3x) lidocaine patch may not
meet any or all endpoints of a clinical study and that any data
generated from such studies may not support a regulatory submission
or approval; risks related to seeking regulatory approvals and
conducting clinical trials; and other matters that are described in
Sorrento's Annual Report on Form 10-K for the year ended December
31, 2018, and subsequent Quarterly Reports on Form 10-Q filed with
the Securities and Exchange Commission, 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 we undertake no obligation
to update any forward-looking statement in this press release
except as required by law. In addition, the preliminary gross sales
information presented in this press release is based on Sorrento’s
and Scilex Holding Company’s current expectations and may be
adjusted as a result of, among other things, completion of
customary quarterly review procedures.
Media and Investor Relations
Contact: Alexis Nahama, SVP Corporate Development
Telephone: 1.858.203.4120
Email: mediarelations@sorrentotherapeutics.com
Website: www.sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.
ZTlido® and G-MAB™ are trademarks owned by Scilex
Pharmaceuticals Inc. and Sorrento, respectively.
SEMDEXA™ (SP-102) is a trademark owned by Semnur
Pharmaceuticals, Inc. A proprietary name review by the FDA is
planned.
Seprehvir®, is a registered trademark of Virttu Biologics
Limited, a wholly-owned subsidiary of TNK Therapeutics, Inc. and
part of the group of companies owned by Sorrento Therapeutics,
Inc.
All other trademarks are the property of their respective
owners.
© 2019 Sorrento Therapeutics, Inc. All Rights Reserved.
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