The stock of Sorrento Therapeutics Inc (NASDAQ:SRNE) closed at $2.95 and maintained the same position in yesterday’s trading session. Scilex Pharmaceuticals Inc, a subsidiary of Sorrento Therapeutics Inc has proceeded to file a marketing authorization application in the European Union for its lead product candidate, ZTlido™.
The company’s spokesperson opined, “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™.”
Basically, the drug has to get in contact with the skin surface in order to deliver the desired effect. He disclosed that the UK was going to lead review agency or the reference member state with corresponding filings in a number of countries including France, Germany, Italy, Spain and Ireland. MAA is associated with a review time of about 210 days and it is critical to point out that if everything goes according to plan by the 4th quarter of 2018 a decision will have been arrived at.
At the moment, the company is carrying out an evaluation of the various commercial options and partnerships as well for the EU, with 2019 being the potential commercial launch data for Europe. The other thing is that Scilex is at the moment is looking forward for the FDA to review its new drug application for ZTlido™.
Sorrento Therapeutics is one of the few companies around the globe that have come across very serious challenges to hit the highest notches in terms of business success. An official working with the company outlined that they look back with great pride whenever they asses how they were able to move past those challenges.
The approval the product will mark a new start for the company since it will be able to generate high revenues as well as offer high end medical assistance to persons around the globe.