– 505(b)(2) NDA resubmission is expected in mid-2017
December 5, 2016
SAN DIEGO, Dec. 5, 2016 /PRNewswire/ — SCILEX Pharmaceuticals Inc. (“SCILEX”), a subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE, “Sorrento”) today announced that its pivotal study for lead investigational product, ZTlido™ (lidocaine patch 1.8%), has met a primary endpoint establishing comparative pharmacokinetics and a secondary endpoint of bioequivalence for ZTlido as compared to the reference product, Lidoderm® (lidocaine patch 5.0%).
The full data will be resubmitted to the U.S. Food and Drug Administration (FDA) as part of the 505(b)(2) new drug application (NDA) in mid-2017.
ZTlido is a next-generation lidocaine patch currently in development for the treatment of post-herpetic neuralgia (“PHN”), a severe neuropathic pain condition. The elderly population, individuals that have suffered a Shingles infection, HIV/AIDS and cancer patients are at highest risk of contracting PHN. In the 2016 Centers for Disease Control and Prevention Guideline for Prescribing Opioids in Chronic Pain, topical lidocaine is recommended for the treatment of neuropathic pain. The prescription lidocaine patch market totaled almost $700 million in 2015.
ZTlido’s anhydrous patch is based on a novel and proprietary technology that contains only 36 mg of lidocaine versus Lidoderm, which holds 700 mg of lidocaine per patch.
“We are very satisfied with the data from this pivotal study, and are now closer to meeting our objective with ZTlido, which is to provide an ultra-thin and pliable patch for patients to better manage the debilitating pain associated with PHN. Our market research shows that these attributes are key to enhancing patient compliance and potentially, enabling better treatment outcomes,” said Anthony Mack, President of SCILEX.
“Sorrento is pleased with the outcome of this study and believes, based on recent discussions with the FDA, that the data will be supportive of SCILEX’ resubmission of its NDA to the FDA. In addition, the positive data is a key validation of SCILEX’ novel technologies and ability to swiftly address important, unmet needs to ameliorate the treatment of acute and chronic conditions. This was a key impetus for Sorrento’s acquisition of SCILEX last month. We are confident that given its potential commercial differentiation, ZTlido will be able to gain a meaningful share of the $700 million lidocaine patch market,” said Dr. Henry Ji, President and Chief Executive Officer of Sorrento.
The clinical study was a randomized, comparative pharmacokinetic study in 54 health subjects designed to characterize the systemic exposure, pharmacokinetics, apparent dose, bioequivalence, and safety of ZTlido against Lidoderm.
An initial analysis of the data available from the study demonstrates the bioequivalence of ZTlido to Lidoderm and that the two products were comparable on two key pharmacokinetic parameters: maximum drug plasma concentration (Cmax) and total drug exposure (area under the curves, or AUCs). The data are summarized below. SCILEX is still analyzing the data for other endpoints in the study.
| PK Parameter | Geometric Mean (Test/Reference *100%) | 90% Confidence Interval | |
| Lower Bound (80.0%) | Upper Bound (125.0%) | ||
| Cmax | 89.5% | 83.8% | 95.5% |
| AUC0-t | 88.2% | 84.1% | 92.5% |
| AUC0-inf | 87.8% | 83.8% | 92.0% |
About SCILEX Pharmaceuticals Inc.
SCILEX, located in San Diego, California, a majority-owned subsidiary of Sorrento, leverages on its core, proprietary technologies to responsibly develop next generation, branded pharmaceutical products to better manage critical conditions and maximize the quality of life of patients and healthcare providers. We are uncompromising in our focus to become the global pharmaceutical leader committed to social, environmental, economic, and ethical responsibility. Dedicated to using our internal partnerships, we deliver the next generation of trailblazing products that are responsible by design. The Company’s lead product under development, ZTlido™ (lidocaine patch 1.8%), is a branded lidocaine patch formulation is being developed for relieving the pain of post-herpetic neuralgia, also referred to as after-shingles pain. For more information visit www.scilexpharma.com.
About Sorrento Therapeutics, Inc.
Sorrento is an antibody-centric, clinical stage biopharmaceutical company developing new treatments for pain management, cancer, inflammation and autoimmune diseases. Sorrento’s lead product candidates include late-stage pain drugs, therapeutic antibodies for cancer, inflammation and autoimmune diseases, as well as clinical stage immune-cellular therapies targeting solid tumors.
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. and its subsidiaries 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 outcome of the data from a clinical trial for ZTlido™, the re-submission of an NDA for ZTlido™, SCILEX’ prospects, Sorrento’s M&A strategy and Sorrento’s ability to accelerate the development of its lead programs, particularly in oncology, in the clinic. 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: that ZTlido™ may not meet all endpoints of the clinical study, that the data may not support an NDA resubmission 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, 2015, as amended. 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.
ZTlido™ is a trademark owned by SCILEX Pharmaceuticals Inc. A proprietary name review by the FDA is planned.
All other trademarks and trade names are the property of their respective owners.
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