Sorrento Receives Brazilian Health Regulatory Agency (ANVISA) Approval for COVISTIX™ (COVID-19 Virus Antigen Detection Test) for Brazil

  • COVISTIX now approved for point of care use in symptomatic patients by ANVISA (national agency for approval of food, cosmetics, and medical devices) in Brazil.
  • Commercialization in progress with distribution agreement locally established and initial purchase orders pending processing.
  • COVISTIX test is an ideal diagnostic tool for potential deployment in surveillance and disease tracking programs.

SAN DIEGO, Nov. 03, 2021 (GLOBE NEWSWIRE) -- 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:

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.

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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.

Alexis Nahama, DVM (SVP Corporate Development)

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