Sorrento Subsidiary, SCILEX Pharmaceuticals, Announces Key Endpoints Met in the European Union Pivotal Bioequivalence Clinical Study for Its Lead Product, ZTlido™
- Marketing Authorization Application is expected to be filed in mid-2017
SAN DIEGO, Jan. 9, 2017 /PRNewswire/ -- SCILEX Pharmaceuticals Inc. ("SCILEX"), a subsidiary of Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") today announced that its pivotal study for its lead investigational product, ZTlido™ (lidocaine patch 1.8%), has met a primary endpoint establishing comparative pharmacokinetics and a secondary endpoint of bioequivalence as compared to the reference product in Europe, Versatis® (lidocaine medicated plaster 5%).
This study (EU pivotal study) was performed similarly to the previously reported US pivotal study which established comparative pharmacokinetics and bioequivalence between ZTlido™ and Lidoderm® (lidocaine patch 5%). The full data is planned to be filed with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom as part of a hybrid Marketing Authorization Application (MAA) 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 the highest risk of contracting PHN. Versatis is recommended as a first-line treatment for PHN by the European Federation of Neurological Societies. The sales for Versatis® in Europe totaled over $250 million in 2015.
ZTlido's anhydrous patch is based on a novel and proprietary technology that contains only 36 mg of lidocaine versus Versatis, which holds 700 mg of lidocaine per patch.
"We are pleased to report consistently positive results now for both our US and European pivotal studies and look forward to moving this key product closer to commercialization. We believe ZTlido™'s ultra-thin and pliable features will be instrumental in helping patients better manage the debilitating pain associated with PHN," said Anthony Mack, President of SCILEX.
"Sorrento is equally pleased with the outcome of this data on the heels of the positive US pivotal study," said Dr. Henry Ji, President and Chief Executive Officer of Sorrento. "The European Union represents an attractive opportunity for ZTlido™ and we are now in a strong position to further discussions with potential strategic partners for that region."
The EU pivotal trial was a randomized, cross-over, comparative pharmacokinetic study designed to characterize the systemic exposure, pharmacokinetics, apparent-dose, bioequivalence, and safety of ZTlido™ versus Versatis® in 54 healthy subjects.
An initial analysis of the data establishes the bioequivalence of ZTlido™ to Versatis® 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). These data are summarized below. SCILEX is still analyzing the data for other endpoints in the study.
| PK Parameter |
Geometric Mean |
90% Confidence Interval |
|
| Lower Bound |
Upper Bound |
||
| Cmax |
90.5% |
85.5% |
95.8% |
| AUC0-t |
89.4% |
85.3% |
93.6% |
| AUC0-inf |
89.1% |
85.2% |
93.2% |
About SCILEX Pharmaceuticals Inc.
SCILEX, located in San Diego, California and a majority-owned subsidiary of Sorrento Therapeutics, 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. By leveraging on key strategic partnerships, our goal is to deliver the next generation of trailblazing products that are responsible by design. The Company's lead product candidate under development, ZTlido™ (lidocaine patch 1.8%), is a branded lidocaine patch which is being developed for the treatment of pain associated with post-herpetic neuralgia (PHN), 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 cancer, inflammation and autoimmune diseases. Sorrento's lead product candidates include oncolytic immunotherapies and cellular therapies for oncology and hematological malignancies.
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 filing of an MAA for ZTlido, the movement toward commercialization, ZTlido's ability to manage pain, the potential for partnerships in the EU, SCILEX's prospects, Sorrento's strategy and other forward-looking statements. 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 MAA filing 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.
© 2017 Sorrento Therapeutics, Inc. All Rights Reserved.
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