Sorrento Receives EUA Approval and Import License From Mexico Authority COFEPRIS For COVI-STIX™ (COVID-19 Virus Rapid Antigen Detection Test) and Plans Product Launch With Initial Shipments in July

News date: 24 June 2021Source: https://www.globenewswire.com/news-release/2021/06/24/2252863/0/en/Sorrento-Receives-EUA-Approval-and-Import-License-From-Mexico-Authority-COFEPRIS-For-COVI-STIX-COVID-19-Virus-Rapid-Antigen-Detection-Test-and-Plans-Product-Launch-With-Initial-Shi.html
  • Sorrento received official EUA registration and product import license: COFEPRIS EUA registration number “OFICIO: CAS/10720/2021”.
     
  • Sorrento is establishing its “Sorrento Mexico Ltd” subsidiary to enable commercialization of COVI-STIX™ and future COVID-19 related products in the country.
     
  • Sorrento expects the first shipments for initial COVI-STIX test orders to be delivered in July.

SAN DIEGO, June 24, 2021 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (Nasdaq: SRNE, "Sorrento") today announced that following its receipt of EUA approval from COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) under registration number “OFICIO: CAS/10720/2021”, it is establishing a local “Sorrento Mexico Ltd” subsidiary to manage commercial operations in Mexico.

COVI-STIX is a sensitive and rapid (approximately 15-minute) diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal or nasopharyngeal samples of patients ("Inmunoensayo de flujo lateral para la detección cualitativa de la proteína nucleocápside del SARS-CoV-2"). COFEPRIS issued Emergency Use Authorization (EUA) approval and an importation permit for COVI-STIX on June 14, 2021.

Sorrento will commercially launch the COVI-STIX test in Mexico with the first shipments expected to be delivered in July.

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™”). Sorrento is also developing potential antiviral therapies and vaccines against coronaviruses, including COVIGUARD™, COVI-AMG™, COVISHIELD™, Gene-MAb™, COVI-MSC™ and COVIDROPS™; and diagnostic test solutions, including COVITRACK™, COVI-STIX™ 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 IB 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 Sorrento establishing a subsidiary in Mexico for commercialization of the COVI-STIX test and future approved products; the sensitivity and speed at which COVI-STIX provides results or is able to provide results; the expected timing for delivery of the first shipments of COVI-STIX; 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 the commercialization of COVI-STIX, and additional regulatory clearances of Sorrento's products; risk of difficulties or delays in launching COVI-STIX in Mexico; risks of manufacturing and supplying diagnostic 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 product commercialization 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.