Sorrento Therapeutics, Inc. (Nasdaq: SRNE, “Sorrento”) today
announced receipt of approval from the Brazilian regulatory agency
(ANVISA) for COVISTIX in Brazil.
COVISTIX manufacturing approval (for good
manufacturing practices) from ANVISA was published in the Brazilian
government official journal on October 18th under registration CNPJ
17700763/0001-48, resolution #3951.
COVISTIX marketing authorization from ANVISA was
published in the Brazilian government official journal on November
3rd under the same registration, with reference #
25351.041767/2021-72 / 80961800001.
The registration will be held for Sorrento by
FUTURA Ltd, a highly respected local partner for hospitals and
direct point of care distribution of prescription drugs and health
products, while SYNOVA Ltd will distribute the test among their
client network of diagnostic laboratories.
COVISTIX is a rapid (approximately 15-minute)
diagnostic test for the detection of the SARS-CoV-2 virus
nucleocapsid antigen in nasal samples of patients. With close to
21M COVID-19 cases and over 500,000 attributable deaths to date,
Brazil has been severely impacted by the COVID-19 pandemic, and the
government is actively looking to expand their testing
capabilities. With close to 20,000 new cases per day despite active
vaccination programs, the need to test remains high and represents
a cornerstone of the strategy to curb the spread of disease and new
variants of concern.
With today’s approval, Sorrento will be able to
offer a high quality and affordable diagnostic solution for Brazil.
In addition, recent data made available by an independent third
party favorably compared COVISTIX to a leading ex-USA rapid
diagnostic test, confirming the superior sensitivity of COVISTIX in
a field study. The full study results can be accessed using the
following link:
https://www.medrxiv.org/content/10.1101/2021.09.10.21263410v1
This approval is expected to allow immediate commercial
deployment in Brazil and in multiple Latin American countries with
close ties to the Brazilian market.
“We are very grateful to ANVISA for working with
us closely on this approval for our COVISTIX diagnostic product in
Brazil,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “We
look forward to working even more closely with the government to
help deploy our test at large scale. We have been building our
manufacturing capacity in anticipation of EUA clearances in
multiple countries in need of highly sensitive, and simple COVID-19
rapid antigen testing.”
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, COVIGUARD™, COVI-AMG™,
COVISHIELD™, COVI-MSC™ and COVIDROPS™; and diagnostic test
solutions, including COVITRACK™, COVISTIX™ and COVITRACE™.
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 post-herpetic neuralgia. RTX has
completed a Phase 1B trial for intractable pain associated with
cancer and a Phase 1B trial in osteoarthritis patients. SEMDEXA is
in a pivotal Phase 3 trial for the treatment of lumbosacral
radicular pain, or sciatica. ZTlido® was approved by the FDA on
February 28, 2018.
For more information visit
www.sorrentotherapeutics.com.
Forward-Looking Statements
This press release and any statements made for
and during any presentation or meeting contain forward-looking
statements related to Sorrento Therapeutics, Inc., under the safe
harbor provisions of Section 21E of the Private Securities
Litigation Reform Act of 1995 and subject to risks and
uncertainties that could cause actual results to differ materially
from those projected. Forward-looking statements include statements
regarding COVISTIX; the performance capabilities of COVISTIX,
including its sensitivity and specificity; the speed at which
COVISTIX provides results or is able to provide results; the
expected entry into a distribution agreement to enable purchase
orders for the distribution of COVISTIX; the potential deployment
of COVISTIX as a tool for surveillance and disease tracking
programs; the continued commercialization of COVISTIX in Brazil and
in multiple Latin American countries; Sorrento’s manufacturing
capacity and ability to produce and deliver a high volume of
COVISTIX tests; and Sorrento’s potential position in the
diagnostics and therapeutics industries. 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 and
its subsidiaries', affiliates’ and partners’ technologies and
prospects and collaborations with partners, including, but not
limited to risks related to conducting additional studies and
seeking additional regulatory approvals for COVISTIX, including the
timing for receipt of any such approvals; conducting and receiving
results of clinical trials; clinical development risks, including
risks in the progress, timing, cost, and results of clinical trials
and product development programs; risk of difficulties or delays in
obtaining regulatory approvals; risks that clinical study results
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 that prior test, study and trial
results may not be replicated in future studies and trials; risks
of manufacturing and supplying drug product; risks related to
leveraging the expertise of its employees, subsidiaries, affiliates
and partners to assist the company in the execution of its COVID-19
therapeutic product candidates strategies; risks related to the
global impact of COVID-19; and other risks that are described in
Sorrento's most recent periodic reports filed with the Securities
and Exchange Commission, including Sorrento's Annual Report on Form
10-K for the year ended December 31, 2020, 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.
Sorrento® and the Sorrento logo are registered
trademarks of Sorrento Therapeutics, Inc.
G-MAB™, DAR-T™, SOFUSA™, COVIGUARD™, COVI-AMG™,
COVISHIELD™, Gene-MAb™, COVIDROPS™, COVI-MSC™, COVITRACK™,
COVITRACE™ and COVISTIX™ are trademarks of Sorrento Therapeutics,
Inc.
SEMDEXA™ is a trademark of Semnur
Pharmaceuticals, Inc.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc.
All other trademarks are the property of their
respective owners.
©2021 Sorrento Therapeutics, Inc. All Rights
Reserved.
Contact
Alexis Nahama, DVM (SVP Corporate Development)
Email: mediarelations@sorrentotherapeutics.com
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