Sorrento Therapeutics Inc (SRNE)

[XenaLives]

Sorrento Establishes Business Unit to Address Market Opportunity for Proprietary Water Soluble Cannabidiol (CBD) Formulations
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April 16, 2019 09:00 ET | Source: Sorrento Therapeutics, Inc.
Cannabidiol (CBD) material from virtually THC-free (<0.3%) hemp plants sources
Excipients on the FDA approved GRAS (Generally Regarded As Safe) list
Water soluble formulations with target concentration exceeding 5% (50 mg/mL)
Development programs for pharmaceutical oral and injectable CBD in multiple disease indications, including but not limited to nervous system, autoimmune or inflammatory diseases and pain management applications
Consumer Health applications and partnerships for high quality CBD concentrates intended for the growing consumer market needs
SAN DIEGO, April 16, 2019 (GLOBE NEWSWIRE) -- Sorrento Therapeutics, Inc. (NASDAQ: SRNE, "Sorrento") announced today that it has established a new business unit to focus on the market potential for its innovative water soluble cannabidiol (CBD) formulation technology.

Cannabidiol (CBD) has been under consideration within the pharmaceutical side of Sorrento for its interesting pharmacological properties and potential clinical benefits in multiple central nervous system, autoimmune or inflammatory disease and pain related indications.

Current CBD products face the limitations of oil-based formulations. Available oral CBD products, formulated in sesame or olive oil, can be associated with gastro-intestinal intolerance (diarrhea). It is anticipated that aqueous formulations would overcome this inconvenient characteristic. The challenge so far has been to achieve comparable concentrations between oil or water based formulations given the lipophilic properties of CBD.

Sorrento scientists have extensive experience developing innovative drug formulations to solubilize otherwise insoluble pharmaceutical compounds, utilizing GRAS (generally recognized as safe) excipients. Multiple promising water soluble formulations are currently in stability studies for the drug development program. Safety assessment and pharmacokinetic studies in animals are under way to support water soluble human CBD drug development (IND enabling studies). If bioequivalence is confirmed in animal studies, the selected water-based formulation would be eligible for further human studies towards an FDA approval using the 505(b)(2) pathway for any indication currently approved for CBD.

Some Sorrento pharmaceutical formulations have been identified as highly scalable and therefore great candidates for a consumer application. Sorrento scientists have also worked towards achieving formulations that are preservative free and with no known impurities. These pharmaceutical standards are often lacking in CBD consumer business products.

The Sorrento consumer-targeted CBD concentrate could range anywhere from 5% to 10% (50 - 100 mg/ml). This concentration range is believed to be among the highest in the industry, and potentially the highest concentration achieved for a water soluble formulation.

The Company has initiated discussions with global food and beverage producers that have a strong interest in non-oil based CBD concentrate products. Sorrento is also in the process of securing exclusive supply agreements with hemp growers and CBD purification facilities in preparation for significant demand of high quality hemp plant materials and water soluble and purified CBD.

“Without distracting from our pharmaceutical business, we have the ability to leverage another Sorrento innovative technology – this time from our formulation experts – and make it available to the broader consumer market” stated Dr. Henry Ji, CEO and Chairman of Sorrento Therapeutics. “Longer-term, we may consider spinning off our CBD consumer business into an independently operated company if appropriate, while our research and clinical development team continues to explore the potential pharmaceutical applications of cannabidiol (CBD) for the medical markets”.

https://www.globenewswire.com/news-release/2019/04/16/1804804/0/en/Sorrento-Establishes-Business-Unit-to-Address-Market-Opportunity-for-Proprietary-Water-Soluble-Cannabidiol-CBD-Formulations.html