SAN DIEGO, CA, USA I November 14, 2017 I Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (“Sorrento”), announced today that Scilex Pharmaceuticals Inc. (“Scilex”), a majority-owned subsidiary of Sorrento, filed the European Marketing Authorization Application (MAA) for its lead product candidate, ZTlido™ (lidocaine medicated plaster 1.8%), through a hybrid regulatory pathway with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK).
ZTlido™ was specifically designed to efficiently deliver lidocaine and have superior adhesion as compared to the US and EU reference products, Lidoderm®/ Versatis® respectively, in recognition that adhesion is critical to the safety, efficacy and quality of a patch or medicated plaster pharmaceutical product. This is especially the case for patch or medicated plaster systems such as ZTlido™, where the drug is contained in the adhesive and must be in contact with the skin to deliver the drug.
The UK will be the reference member state, or lead review agency, with corresponding filings in multiple other countries including Germany, France, Spain, Italy and Ireland.
The review time for the MAA is 210 days with clock stops for information requests from agencies. Scilex expects to have a decision in the 4th quarter of 2018.
The company is currently evaluating commercial options and partnerships for the EU, with a potential commercial launch date for Europe in 2019.
Scilex currently has a new drug application under review with the FDA in the US for ZTlido™.
About Scilex Pharmaceuticals Inc.
Scilex, a majority-owned subsidiary of Sorrento Therapeutics located in San Diego, California, 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. Leveraging on our global 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 for the treatment of 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 a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. 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”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Sephrevir®”).
Sorrento’s commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) and ZTlido. Resiniferatoxin is completing a phase IB trial in terminal cancer patients. ZTlido is in regulatory review following NDA re-submission.
SOURCE: Sorrento Therapeutics
Post Views: 31
SAN DIEGO, CA, USA I November 14, 2017 I Sorrento Therapeutics, Inc. (NASDAQ: SRNE) (“Sorrento”), announced today that Scilex Pharmaceuticals Inc. (“Scilex”), a majority-owned subsidiary of Sorrento, filed the European Marketing Authorization Application (MAA) for its lead product candidate, ZTlido™ (lidocaine medicated plaster 1.8%), through a hybrid regulatory pathway with the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK).
ZTlido™ was specifically designed to efficiently deliver lidocaine and have superior adhesion as compared to the US and EU reference products, Lidoderm®/ Versatis® respectively, in recognition that adhesion is critical to the safety, efficacy and quality of a patch or medicated plaster pharmaceutical product. This is especially the case for patch or medicated plaster systems such as ZTlido™, where the drug is contained in the adhesive and must be in contact with the skin to deliver the drug.
The UK will be the reference member state, or lead review agency, with corresponding filings in multiple other countries including Germany, France, Spain, Italy and Ireland.
The review time for the MAA is 210 days with clock stops for information requests from agencies. Scilex expects to have a decision in the 4th quarter of 2018.
The company is currently evaluating commercial options and partnerships for the EU, with a potential commercial launch date for Europe in 2019.
Scilex currently has a new drug application under review with the FDA in the US for ZTlido™.
About Scilex Pharmaceuticals Inc.
Scilex, a majority-owned subsidiary of Sorrento Therapeutics located in San Diego, California, 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. Leveraging on our global 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 for the treatment of 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 a clinical stage, antibody-centric, biopharmaceutical company developing new therapies to turn malignant cancers into manageable and possibly curable diseases. 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”), intracellular targeting antibodies (“iTAbs”), antibody-drug conjugates (“ADC”), and clinical stage oncolytic virus (“Sephrevir®”).
Sorrento’s commitment to life-enhancing therapies for cancer patients is also demonstrated by our effort to advance a first-in-class (TRPV1 agonist) non-opioid pain management small molecule in Resiniferatoxin (“RTX”) and ZTlido. Resiniferatoxin is completing a phase IB trial in terminal cancer patients. ZTlido is in regulatory review following NDA re-submission.
SOURCE: Sorrento Therapeutics
Post Views: 31
