Scilex Holding Company (“Scilex”), a majority-owned subsidiary of
Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento"), today
announced continuous sales growth in ZTlido® from quarter to
quarter in 2020. Scilex expects third quarter 2020 ZTlido® net
sales to grow 26% to approximately $7.2MM, compared to $5.7MM in
Q2-2020. The preliminary third quarter 2020 net sales information
presented in this press release is based on Scilex’s current
expectations and may be adjusted as a result of, among other
things, completion of customary quarterly review procedures.
Scilex’s SP-102 (SEMDEXA™) is currently being evaluated in a
pivotal Phase 3 clinical trial in the U.S. to evaluate patients
with lumbosacral radicular pain/sciatica. The trial is expected to
complete enrollment in the fourth quarter of 2020 and top-line data
is expected in the second quarter of 2021. Scilex
intends to use the results from this pivotal Phase 3 trial to
discuss with U.S. health authorities the basis for licensure
application to the U.S. Food and Drug Administration (FDA) for this
high unmet need indication where no treatments have been approved
and which is responsible for millions of people suffering in the
U.S. alone. Scilex has extensive clinical and pre-clinical data
(including multiple Phase 2 clinical trials) with the novel viscous
formulation of SP-102, which was designed to provide extended local
effect for sciatica patients. The robust data collected over the
course of the company’s multi-year clinical development program
will be presented to the U.S. FDA as part of a new drug
application.
The CLEAR (“Corticosteroid Lumbar Epidural Analgesia for
Radiculopathy”) clinical study is a randomized, double-blind,
placebo-controlled Phase 3 trial that is expected to enroll 400
patients with lumbosacral radicular pain at 40+ sites across the
U.S. The primary endpoint of the study is mean change in the
Numeric Pain Rating Scale (NPRS) for leg pain with SP-102 epidural
injection compared to intramuscular injection of placebo over four
weeks. The secondary endpoints include other measures of pain at 4
and 12 weeks as well as time to repeat injection of SP-102, safety
and function. The study includes an open-label extension to build
the safety database of patients treated with SP-102.
“We are anxiously awaiting a new injectable formulation of
dexamethasone and registration for treatment of radicular pain
based on results of a large, randomized placebo-controlled
multi-center trial. If approved by the FDA, SP-102 would be the
first corticosteroid for epidural injections addressing safety
issues with steroid medications, currently used off-label, and an
important addition to armamentarium of interventional pain
physicians,” said Dr. Steve Cohen, Chief of Pain Medicine and
Professor of Anesthesiology & Critical Care Medicine, Neurology
and Physical Medicine & Rehabilitation, Johns Hopkins School of
Medicine, and Professor of Anesthesiology and Physical Medicine
& Rehabilitation, Walter Reed National Military Medical Center,
Uniformed Services University of the Health Sciences.
SP-102 is a novel, non-opioid injectable viscous gel formulation
in development for the treatment of lumbosacral radicular pain,
containing no neurotoxic preservatives, surfactants, solvents or
particulates. The SP-102 formulation is administered by epidural
injection. Based on preclinical and clinical studies conducted to
date, it extends the residency time at the site of injection and
has not demonstrated the safety concerns that led the FDA to issue
a class warning on the currently off-label use of injectable
corticosteroids to include information about the risk of serious
neurologic events with epidural steroid injections (ESIs).
“Lumbosacral radicular pain, otherwise known as sciatica, is
commonly treated by off-label epidural steroid injections. There
are an estimated ten to eleven million epidural steroid injections
administered per year in the U.S. alone and there are no approved
steroids for epidural injections.2 The clinical results for the
pivotal Phase 3 trial for SP-102 will be a seminal milestone for
Scilex and may provide encouraging news for the many millions of
people who are confronting debilitating radicular pain/sciatica. We
believe that SP-102 could be the first FDA-approved epidural
steroid product for patients suffering from this common, painful
condition,” said Jaisim Shah, President and Chief Executive Officer
of Scilex.
In 2019, the overall estimated number of ESI procedures in the
U.S. was 11.6 million across all Medicare and private coverage
patients, with lumbar radiculopathy / sciatica procedures
comprising approximately 88% of all ESIs administered. Despite
widespread utilization of ESIs, concerns persist in the market
about particulate steroids and potential side effect and safety
concerns (e.g., stroke) from current off-label use. As a result, a
significant unmet medical need exists within the market for a
potent, non-particulate ESI formulation that demonstrated safety
and effectiveness in controlled clinical trial
evaluations.1
In the U.S., more than 30 million people live with low back and
radicular pain, with this population expected to grow as the
population ages.4,5 Many patients experience moderate to severe
pain with intolerance and/or inadequate response to current
analgesic therapies such as opioids and nonsteroidal
anti-inflammatory drugs (NSAIDs).6,7 There is a great need for
highly effective analgesic medications to provide patient relief
without the toxicity and tolerability challenges of NSAIDs and
opioids.5 Opioid prescriptions account for about 40 percent of the
chronic pain market and carry a well-known risk of abuse and
misuse, underscoring the need for alternative pain therapies
without the medical and societal challenges.5,8
Chronic pain affects 100 million, or almost one- in-three,
Americans9, with nearly 33 million patients suffering from lower
back pain in the U.S.10, and costs the United States approximately
$560 to $635 billion annually., Government agencies, physicians,
patients, and payers are looking for alternatives to opioids to
reduce the risk of dependency or addiction, and serious side
effects (such as respiratory depression and constipation), while
still offering potent solutions for people living with chronic
pain.
About Sorrento Therapeutics,
Inc.
Sorrento is a clinical stage, antibody-centric,
biopharmaceutical company developing new therapies to treat cancers
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"), clinical stage immuno-cellular therapies
("CAR-T", "DAR-T"), antibody-drug conjugates ("ADCs"), and clinical
stage oncolytic virus ("Seprehvir®", “Seprehvec™”). Sorrento is
also developing potential antiviral therapies and vaccines against
coronaviruses, including COVIDTRAP™, ACE-MAB™, COVI-MAB™,
COVI-GUARD™, COVI-SHIELD™, COVI-AMG™ and T-VIVA-19™; and diagnostic
test solutions, including COVI-TRACK™, COVI-STIX™ and
COVI-TRACE™.
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 ZTlido® (lidocaine topical system)
1.8% for the treatment of post-herpetic neuralgia. RTX has
completed a phase 1B trial for intractable pain associated with
cancer and a phase 1B trial in osteoarthritis patients. ZTlido® was
approved by the FDA on February 28, 2018. SP-102 is undergoing a
Phase 3 pivotal trial for the treatment of lumbosacral radicular
pain/sciatica.
For more information visit www.sorrentotherapeutics.com
About Scilex Holding
Company.
Scilex Holding Company, a majority-owned subsidiary of Sorrento
Therapeutics, Inc. (Nasdaq: SRNE), is a commercial-stage,
non-opioid pain management company focused on the development and
commercialization of topical and injectable therapies. Scilex
targets indications with high unmet needs and large market
opportunities with non-opioid therapies for the treatment of
patients with moderate to severe chronic 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 a Phase 2 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 two product candidates are
SP-102 (10 mg, dexamethasone sodium phosphate viscous gel), or
SEMDEXA™, a Phase 3, novel, viscous gel formulation of a widely
used corticosteroid for epidural injections to treat lumbosacral
radicular pain, or sciatica, and SP-103 (lidocaine topical system)
5.4%, or SP-103, a Phase 2, next-generation, triple-strength
formulation of ZTlido, for the treatment of chronic low back
pain.
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
Sorrento Therapeutics, Inc. and its subsidiaries, including but not
limited to Scilex Holding Company, Scilex Pharmaceuticals, Inc. and
Semnur Pharmaceuticals, Inc. 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 expected timing for
completing enrollment for the Phase 3 trial for SP-102; expected
third quarter 2020 ZTlido® net sales; the expected timing for
receipt of top-line data for the Phase 3 trial for SP-102;
discussions with the FDA and health authorities regarding any new
drug application for SP-102; clinical trial endpoints; expectations
that SP-102 may be the first FDA-approved epidural steroid product
for the treatment of sciatica; the outcome of the data from a
clinical trial for SP-102; Scilex Holding’s prospects; future
clinical trials and the results thereof and market and patient
population trends. 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 the completion of the customary
quarterly financial statement review procedures; clinical
development risks, including risks in the progress, timing, cost,
and results of clinical trials and product development programs;
risks that prior test, study and trial results may not be
replicated in future studies and trials; risks that SP-102 may not
meet all endpoints of the clinical study and that the data may not
support an NDA submission; risks of difficulties or delays in
obtaining regulatory approvals and risks related to the global
impact of COVID-19. 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.
Media and Investor Relations
Contact: Alexis Nahama, SVP Corporate DevelopmentTelephone:
1.858.203.4120Email:
mediarelations@sorrentotherapeutics.comWebsite:
www.sorrentotherapeutics.com
Sorrento® and the Sorrento logo are registered trademarks of
Sorrento Therapeutics, Inc.
G-MAB™, COVI-GUARDTM, COVI-SHIELD™, COVI-AMG™, COVIDTRAP™,
T-VIVA-19™, COVI-MAB™, ACE-MABTM, COVI-TRACK™, COVI-STIX™ and
COVI-TRACE™ are trademarks of Sorrento Therapeutics, Inc.
ZTlido® is a trademark owned by Scilex Pharmaceuticals Inc.
All other trademarks are the property of their respective
owners.
© 2020 Sorrento Therapeutics, Inc. All Rights Reserved.
References
(1) Syneos Health Consulting; Syneos is a leading
management consulting firm specializing in life sciences
industry(2) NEJM July 3, 2014 Editorial: Epidural
Glucocorticoid Injections in Patients with Lumbar Spinal Stenosis;
Gunnar B.J. Andersson, M.D., Ph.D.(3) Institute of
Medicine, National Center for Health Statistics, and Datamonitor
December 2009(4) Decisions Resources Group. Chronic
Pain: Disease Landscape and Forecast. 2016; 76 & 80(5)
Decisions Resources Group. Chronic Pain: Disease
Landscape and Forecast. 2016; 40(6) Decisions
Resources Group. Chronic Pain: Disease Landscape and Forecast.
2016; 62(7) Decisions Resources Group. Chronic Pain:
Disease Landscape and Forecast. 2016; 62(8) Decisions
Resources Group. Chronic Pain: Disease Landscape and Forecast.
2016; 8(9) 2015 NIH Report: David B. Reuben, Anika A.
H. Alvanzo, Takamaru Ashikaga, G. Anne Bogat, Christopher M.
Callahan, Victoria Ruffing, David C. Steffens. National Institutes
of Health Pathways to Prevention Workshop: The Role of Opioids in
the Treatment of Chronic Pain. Annals of Internal Medicine, 2015;
DOI: 10.7326/M14-2775(10) Decision Resources Group (2016)
Sorrento Therapeutics (NASDAQ:SRNE)
Historical Stock Chart
From Aug 2024 to Sep 2024
Sorrento Therapeutics (NASDAQ:SRNE)
Historical Stock Chart
From Sep 2023 to Sep 2024