Pharma Focus Asia

Sorrento Therapeutics Announces the Merger of Scilex and Semnur to Create a Global Leader

Monday, March 25, 2019

Sorrento Therapeutics, Inc announced today that its majority owned subsidiary Scilex Pharmaceuticals Inc. (Scilex) has closed a transaction to merge with Mountain View, California, based Semnur Pharmaceuticals, Inc. (Semnur) to form a new company, Scilex Holding Company (Scilex Holding). Sorrento’s equity stake in Scilex (77%) has been converted into a 58% stake in Scilex Holding. With Scilex’s lead product ZTlido® (lidocaine topical system 1.8%) ramping rapidly in the early months of commercial launch and Semnur’s lead compound (non-opioid corticosteroid gel) in Phase 3 pivotal studies for the treatment of lumbar radicular pain/sciatica with Fast Track status from the FDA, Scilex Holding is well positioned to become a global leader in non-opioid pain management.

“This transaction is highly synergistic. Scilex has built up a commercial organization with over 100 highly experienced sales representatives, fully staffed marketing, market access, and medical liaison teams while Semnur has a very exciting Phase 3 compound in non-opioid pain management.  The synergy is compelling on multiple fronts. With Semnur’s SP102, ZTlido and the RTX product lines, Sorrento is now well positioned to address an approximately $63 billion pain therapeutics market,” stated Dr. Henry Ji, Chairman and CEO of Sorrento. “Semnur CEO Jaisim Shah and his team are bringing a tremendous amount of industry knowledge and an impressive proven record in pharmaceutical commercialization to the combined company.  I am confident that under Jaisim’s leadership, Scilex Holding will emerge as a preeminent force in the industry.”

Mahendra Shah, Chairman of Semnur, which was backed by leading healthcare venture capital firms including Canaan Partners, Frazier Healthcare Partners, and Vivo Capital, commented, “We are very excited for Semnur to be part of the Sorrento family. With the ongoing opioid crisis, both companies have been in active dialogue with local, state and federal agencies on best strategies and methods to treat a continuum of chronic and acute pain conditions using non-addictive non-opioid therapies. We are confident that Scilex Holding can take full advantage of the opportunities created in this paradigm shift.” Newly appointed Scilex Holding CEO Jaisim Shah added “I am delighted to be a part of this strategic combination which collectively underscores our mission to provide innovative non-opioid therapies to as many patients as possible. It also addresses alternative approaches to pain management mandated due to the epidemic overuse of opioids.”  

Semnur’s lead compound SP102 has been awarded fast track status by the FDA.  It is the first non-opioid corticosteroid formulated as a viscous gel injection in development for the treatment of lumbar radicular pain/sciatica, containing no neurotoxic preservatives, surfactants, solvents or particulates. The FDA’s Fast Track program was implemented to expedite the development and regulatory review of therapeutic programs that seek to address significant unmet medical needs.  As Scilex Holding develops SP-102 for lumbar radicular pain, the company will be eligible for more frequent communication with the FDA related to the drug development plan and data necessary to expedite the development of this novel non-opioid pain treatment.  SP-102 is currently in a pivotal trial “Corticosteroid Lumbar Epidural Analgesia for Radiculopathy (C.L.E.A.R.).” The CLEAR study is a randomized, double-blind, placebo-controlled Phase 3 trial that will enroll 400 patients with lumbar radicular pain at 40+ sites across the U.S.  The primary endpoint is mean change in the Numerical Pain Rating Scale for leg pain in patients receiving SP-102 compared to intramuscular injection of placebo over four weeks.  The secondary endpoints include other measures of pain at 4 and 12 weeks as well as time to repeat injection of SP-102, safety and function.  The study includes an open-label extension to build the safety database of patients treated with SP-102.  Lifetime prevalence of lower back pain with radiculopathy ranges from 12% to 43%.

ZTlido® (lidocaine topical system 1.8%) uses an advanced adhesion technology, providing more efficient lidocaine delivery than Lidoderm® (lidocaine patch 5%) over a full 12 hours. Poor adhesion is the most common complaint associated with lidocaine patches and ZTlido® has proven adhesion superiority over Lidoderm®. Post-herpetic neuralgia (PHN) is the most common complication of shingles, a condition caused by the herpes zoster virus. PHN affects an estimated 1 million people in the United States each year.  ZTlido® received its FDA approval through a 505(b)(2) regulatory pathway, which required establishment of its bioequivalence to Lidoderm® in two separate pharmacokinetic studies. ZTlido® was approved by the FDA in February 2018 for relief of pain associated with PHN.  Also under development is a topical system with a three-fold higher concentration of lidocaine, which takes advantage of ZTlido’s thinner and more efficient delivery system to potentially address other types of pain.

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