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Featured Company News - Sorrento Submits NDA for ZTlido Next-Gen Lidocaine Patch; Intends to File an MAA in Europe

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LONDON, UK / ACCESSWIRE / August 31, 2017 / Pro-Trader Daily takes a look at the latest corporate events and news making the headlines for Sorrento Therapeutics, Inc. (NASDAQ: SRNE), following which we have published a free report that can be viewed by signing up at http://protraderdaily.com/optin/?symbol=SRNE. The Company announced on August 29, 2017, that its majority-owned subsidiary, SCILEX Pharmaceuticals, Inc., resubmitted the New Drug Application (NDA) and responded to all of US Food and Drug Administration (FDA) comments related to the initial NDA submission for its lead product candidate, ZTlido. ZTlido is a next-gen, non-opioid, lidocaine patch currently in development for the relief of pain associated with post-herpetic neuralgia (PHN), a severe neuropathic pain condition. For immediate access to our complimentary reports, including today's coverage, register for free now at:

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ZTlido

According to the Company, ZTlido was specifically designed to have superior adhesion as compared to the US and EU reference products Lidoderm/Versatis in recognition that adhesion is critical to the safety, efficacy, and quality of a patch or medicated plaster pharmaceutical product. This case is especially crucial here for a patch or medicated plaster systems such as ZTlido and Lidoderm/Versatis where the drug is contained in the adhesive and must be in contact with the skin to deliver the drug.

The novel Technology, ZTlido, allows the ability to deliver a bioequivalent therapeutic dose of lidocaine for the treatment of PHN pain. However, it does so through a drug load of 36 mg/patch, against 700 mg/patch for Lidoderm and Versatis. This biopharmaceutic efficiency leads to an approximately 30-fold reduction in residual drug in ZTlido after use when compared to Lidoderm and Versatis, and can significantly reduce safety risk to children and pets, and present less drug waste when discarded after use.

The Adhesion Study

On June 14, 2017, SCILEX, a Sorrento-subsidiary, announced that its lead investigational product, ZTlido demonstrated superior adhesion versus the EU reference product, Versatis, during a recently executed comparative adhesion performance study. The data presented complemented a previous clinical adhesion study performed to support the NDA submission for ZTlido in the US, where greater than 90% of the subjects demonstrated greater than 90% adhesion over the administration period of 12 hours, using the FDA recommended 5-point scale.

The adhesion study was designed and carried out as an open label, three-period, single-patch application, adhesion performance study of ZTlido versus Versatis. The study was completed in 44 healthy volunteers, where they were assessed for adhesion at 0, 3, 6, 9, and 12 hours respectively. Adhesion was scored using The European Medicines Agency (EMA) scale ranging from a score of 6 being greater than 95% adhesion and a score of 0, where greater than 70% adhesion represented significant adhesion failure. ZTlido demonstrated superior adhesion as compared to Versatis with a mean adhesion score of 5.35 versus 3.59 for Versatis (p<0.001). After the 12-hour dosage period, ZTlido had a mean adhesion score of 5.006 while Versatis had a mean adhesion of 2.268.

The Announcement

Sorrento announced that the state-of-the-art manufacturing technology used for ZTlido production enabled high drug delivery efficiency with strong adhesive properties. The NDA, subject to being accepted by the FDA, will go through a review process which could be 6 months. If approved, ZTlido could be ready for commercial launch in the US in 2018. The Company also plans to submit a marketing authorization application (MAA) for ZTlido in Europe in Q4 2016. According to the Company, the total full-year 2016 sales of currently approved prescription lidocaine patches in the US and Europe were about $750 million, where it expects ZTlido to be a significant player in the market.

Last Close Stock Review

At the closing bell, on Wednesday, August 30, 2017, Sorrento Therapeutics' stock surged 10.77%, ending the trading session at $1.80. A total volume of 1.11 million shares have exchanged hands, which was higher than the 3-month average volume of 902.83 thousand shares. The Company's stock price rallied 16.13% in the last three months. The stock currently has a market cap of $133.72 million.

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